Rapid PE Triage and Notification (PETN)

K220499 · Ischemaview, Inc. · QAS · May 17, 2022 · Radiology

Device Facts

• Record ID: K220499
• Device Name: Rapid PE Triage and Notification (PETN)
• Applicant: Ischemaview, Inc.
• Product Code: QAS · Radiology
• Decision Date: May 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams. Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Rapid PETN are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

Device Story

Rapid PETN is a radiological computer-assisted triage and notification software. It processes CTPA images to detect suspected central pulmonary embolism (PE). The device operates within the Rapid Platform, utilizing an AI/ML algorithm to analyze images in parallel with standard-of-care interpretation. It runs on a server or standalone desktop application. When a suspected finding is detected, the system sends a notification to clinicians, including compressed preview images for informational purposes. The device does not alter original images and is not for diagnostic use. Clinicians use the notification to prioritize their workflow and must review full images per standard of care. The device benefits patients by potentially reducing time to diagnosis and treatment for PE.

Clinical Evidence

Performance validation used 306 CTPA cases with ground truth established by 3 experts (2:3 confirmation). Primary endpoints: Sensitivity 0.96 (95% CI: 0.92-0.98) and Specificity 0.89 (95% CI: 0.83-0.93). Secondary endpoint: mean processing time 2.64 minutes. Sub-stratification provided for gender, age, scanner manufacturer, slice thickness, and detector rows. No clinical prospective/retrospective patient outcome data reported; validation based on retrospective image analysis.

Technological Characteristics

Software-based radiological triage tool; AI/ML algorithm; DICOM compliant (NEMA PS 3.1-3.20); operates on server or workstation; validated for GE, Siemens, and Toshiba scanners; single-energy CTPA input; non-diagnostic preview image generation; no image alteration or segmentation.

Indications for Use

Indicated for use in adults to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of central pulmonary embolism (PE) pathology in CTPA images. Intended for single-energy exams only.

Regulatory Classification

Identification

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 1. Design verification and validation must include: i. A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. ii. A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (e.g., improved time to review of prioritized images for pre-specified clinicians). iii. Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment. iv. Standalone performance testing protocols and results of the device. v. Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results). 2. Labeling must include the following: i. A detailed description of the patient population for which the device is indicated for use. ii. A detailed description of the intended user and user training that addresses appropriate use protocols for the device. iii. Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality for certain subpopulations), as applicable. iv. A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images. v. Device operating instructions. vi. A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts ( *e.g.,* subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device. (v) Appropriate software documentation ( *e.g.,* device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use; (ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device; (iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( *e.g.,* poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images; (v) Device operating instructions; and (vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (*e.g.,* confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Predicate Devices

• Aidoc Briefcase (K190072)

Submission Summary (Full Text)

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iSchemaView Inc. % Mr. James Rosa SVP Regulatory and Quality 1120 Washington Ave., Ste 200 GOLDEN CO 80401

May 17, 2022

## Re: K220499

Trade/Device Name: Rapid PE Triage and Notification (PETN) Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: April 13, 2022 Received: April 14, 2022

Dear Mr. Rosa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K220499

Device Name Rapid PE Triage and Notification (PETN)

#### Indications for Use (Describe)

Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams.

Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Rapid PETN are intended to be used in conjunction with other patient information and based on ther professional judgment, to assist with trage/proritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 20px;"> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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### 510(k) Summary

### iSchemaView, Inc.'s Rapid PE Triage and Notification (PETN)

This document contains the 510(k) summary for the iSchemaView Rapid PETN. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

## Applicant Name and Address:

| Name: | iSchemaView, Inc. |
|-------------------|------------------------------------------------------------------|
| Address: | 1120 Washington St., Suite 200<br>Golden, CO 80401 |
| Official Contact: | Jim Rosa<br>Phone: [phone]<br>Email: [e-mail] |

February 12, 2022 Summary Preparation Date:

## Device Name and Classification:

| Trade Name: | Rapid PE Triage and Notification (PETN) |
|-----------------------|---------------------------------------------------|
| Common Name: | PACS – Picture Archiving Communications<br>System |
| Classification: | II |
| Product Code: | Primary: QAS |
| Regulation No: | 21 C.F.R. §892.2080 |
| Classification Panel: | Radiology Devices |

#### Predicate Devices:

The iSchemaView Rapid PETN is claimed to be substantially equivalent to the following legally marketed predicate devices:

Aidoc Briefcase (K190072)

#### Device Description:

Rapid PETN is a radiological computer-assisted triage and notification software device. The Rapid PETN module is a contrast enhanced CTPA processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected Central Pulmonary Emboli (PE). The PETN module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of central PE based on positive findings. The Rapid PETN module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

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## Indications for Use:

Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams.

Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Rapid PETN are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

## Technological Characteristics and Substantial Equivalence:

Rapid PETN does not raise new questions of safety or effectiveness compared to the previously cleared Briefcase (K190072). Both devices are radiological computer-aided triage and notification software applications for use with CTPA input. There are minor differences in intended use and technical characteristics with the predicate device; however, with the minor change excluding the ICH claims, the clinical use for Rapid PETN is the same as the CTPA indication for the predicate with no additional risk. Thus, the Rapid PETN software is substantially equivalent.

The following table summarizes and compares data on the Briefcase (K190072) to the Rapid PETN that is the subject of this Traditional 510(k) submission.

| Parameter | K190072 - Predicate Device | Rapid PETN – Subject Device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | QAS | QAS |
| Regulation | 21 CFR §892.2080 | 21 CFR §892.2080 |
| Intended Use/<br>Indications for<br>Use | BriefCase is a radiological computer<br>aided triage and notification software<br>indicated for use in the analysis of<br>non-enhanced head CT and CTPA<br>images. The device is intended to<br>assist hospital networks and trained<br>radiologists in workflow triage by<br>flagging and communication of<br>suspected positive findings of<br>Intracranial Hemorrhage (ICH) and<br>Pulmonary Embolism (PE)<br>pathologies. For the PE pathology,<br>the software is only intended to be<br>used on single-energy exams. | Rapid PE Triage and Notification (PETN)<br>is a radiological computer aided triage and<br>notification software indicated for use in<br>the analysis of CTPA images. The device<br>is intended to assist hospital networks and<br>trained clinicians in workflow triage by<br>flagging and communication of suspected<br>positive findings of central pulmonary<br>embolism (PE) pathology in adults. The<br>software is only intended to be used on<br>single-energy exams.<br><br>Rapid PETN uses an artificial intelligence<br>algorithm to analyze images and highlight<br>cases with detected findings on a server or |
| Parameter | K190072 - Predicate Device | Rapid PETN – Subject Device |
| | BriefCase uses an artificial<br>intelligence algorithm to analyze<br>images and highlight cases with<br>detected findings on a standalone<br>desktop application in parallel to the<br>ongoing standard of care image<br>interpretation. The user is presented<br>with notifications for cases with<br>suspected findings. Notifications<br>include compressed preview images<br>that are meant for informational<br>purposes only and not intended for<br>diagnostic use beyond notification.<br>The device does not alter the original<br>medical image and is not intended to<br>be used as a diagnostic device.<br>The results of BriefCase are intended<br>to be used in conjunction with other<br>patient information and based on<br>their professional judgment, to assist<br>with triage/prioritization of medical<br>images. Notified clinicians are<br>responsible for viewing full images<br>per the standard of care. | standalone desktop application in parallel to<br>the ongoing standard of care image<br>interpretation. The user is presented with<br>notifications for cases with suspected<br>findings. Notifications include compressed<br>preview images that are meant for<br>informational purposes only and not<br>intended for diagnostic use beyond<br>notification. The device does not alter the<br>original medical image and is not intended to<br>be used as a diagnostic device.<br>The results of Rapid PETN are intended to<br>be used in conjunction with other patient<br>information and based on their<br>professional judgment, to assist with<br>triage/prioritization of medical images.<br>Notified clinicians are responsible for<br>viewing full images per the standard of<br>care. Rapid PETN is validated for use on<br>GE, Siemens and Toshiba scanners. |
| User | Radiologist | Radiologist, Clinician |
| Basic PACS<br>Functions | Software package which interfaces<br>to a PACS or allows viewing within<br>the application | Same |
| Computer Platform | PC | Server or Workstation |
| Software | AI/ML | AI/ML |
| DICOM Compliance | Yes, using CT and CTPA | Yes, using CTPA |
| Segmentation | No, Device does not mark,<br>annotate, or direct users' attention<br>to a specific location in the original<br>image | No, Device does not mark, annotate, or<br>direct users' attention to a specific location<br>in the original image |
| Preview Images | Presentation of a small,<br>compressed, black and white<br>preview image that is labeled "Not<br>for diagnostic use"; The device<br>operates in parallel with the<br>standard of care, which remains<br>the default option for all cases. | Presentation of a small, compressed, black<br>and white preview image that is labeled "Not<br>for diagnostic use"; The device operates in<br>parallel with the standard of care, which<br>remains the default option for all cases. |
| Alteration of<br>original image | No | No |
| Removal of cases from<br>workflow queue | No | No |

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# AI/ML Module Development:

Algorithm development, including development validation, was performed using 600 (Pos:300, Neg:300) CTPA cases from multiple sites. The data was split into 480 (Pos:240, Neg:240) training cases and 120 (Pos:60, Neg:60) development validation cases. The optimal design performance for the final solution showed a Sensitivity = 0.98 and Specificity = 0.97. The development data included the following distributions:

| Table 1: Age Distribution for Development & Training | | | | |
|------------------------------------------------------|----------|------------|---------|---------|
| PE status | Mean age | Median age | Min age | Max age |
| Positive (N=300) | 63 | 64 | 22 | 93 |
| Negative (N=300) | 51 | 51 | 17 | 89 |

| Table 2: Gender Distribution for Development & Training | | | |
|---------------------------------------------------------|--------|------|---------|
| PE status | Female | Male | Unknown |
| Positive (N=300) | 52% | 47% | < 1% |
| Negative (N=300) | 63% | 37% | 0% |

| Table 3: Scanner Distribution for Development & Training | | | | | |
|----------------------------------------------------------|-----|---------|---------|---------|---------|
| PE status | GE | Siemens | Philips | Toshiba | Unknown |
| Positive (N=300) | 39% | 22% | 13% | 24% | < 2% |
| Negative (N=300) | 72% | 9% | < 1% | 19% | 0% |

An additional 276 negative cases were included to further assess the specificity of the final model. The data included the following distributions:

| Table 4: Age Distribution for Development Validation | | | | |
|------------------------------------------------------|----------|------------|---------|---------|
| PE status | Mean age | Median age | Min age | Max age |
| Negative (N=276) | 56 | 58 | 19 | 91 |

| Table 5: Gender Distribution for Development Validation | | | |
|---------------------------------------------------------|--------|------|---------|
| PE status | Female | Male | Unknown |
| Negative (N=276) | 55% | 45% | 0% |

| Table 6: Scanner Distribution for Development Validation | | | | | |
|----------------------------------------------------------|-----|---------|---------|---------|---------|
| PE status | GE | Siemens | Philips | Toshiba | Unknown |
| Negative (N=276) | 25% | 4% | 0% | 72% | 0% |

## Clinical Characteristics:

The primary users of Rapid PETN software are medical imaging professionals who analyze CTPA images. Rapid PETN provides notification to the physicians of suspected Central PE. The physicians must evaluate the cases for determination of PE through their normal standard of care review once prioritization is received. The Rapid PETN is intended for Adult cases.

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## Performance Standards:

Rapid PE has been developed in conformance with the following standards, as applicable:

| EN ISO 14971:2019 | Application of Risk Management to Medical Devices |
|--------------------|---------------------------------------------------------|
| IEC 62304:2016 | Medical device software – Software lifecycle processes |
| IEC 62366:2015 | Application of Usability Engineering to Medical Devices |
| NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) |

## Performance Data:

Rapid PE complies with DICOM (Digital Imaging and Communications in Medicine) -Developed by the American College of Radiology and the National Electrical Manufacturers Association (NEMA PS 3.1 - 3.20).

iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid PETN module. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid PETN device provides accurate representation of key processing parameters under a range of clinically relevant perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid PETN Module met all design requirements and specifications.

Final performance validation included 306 CTPA cases with ground truth established by 3 experts using a 2:3 confirmation. The primary endpoint passed with Sensitivity = 0.96 (0.92.0.98) and Specificity = 0.89 (0.83.0.93). The cases were split Male:47%, Female 53% with an age range of 22-95 years. The samples were mixed from GE, Philips, Toshiba and Siemens scanners. The secondary endpoint was passed at 2.64 minutes (2.34-4.80 min) processing time, with negligible notification time using wireless and cellular communications. The following tables provide sub-stratification for demographic and scanner performance:

| Gender | Measure | Estimate | Lower 95%<br>CI | Upper 95%<br>CI | |
|--------------|-------------|----------|-----------------|-----------------|-----------------|
| Female (162) | Sensitivity | 0.934 | 0.855 | 0.972 | |
| | Specificity | 0.930 | 0.856 | 0.968 | |
| Male (144) | Sensitivity | 0.986 | 0.927 | 0.998 | |
| | Specificity | 0.829 | 0.724 | 0.899 | |
| Table 2: Age | | | | | |
| Age | Measure | N | Estimate | Lower 95%<br>CI | Upper 95%<br>CI |
| unknown | Sensitivity | 72 | 0.972 | 0.904 | 0.992 |
| | Specificity | 4 | 0.250 | 0.046 | 0.699 |
| < 50 | Sensitivity | 3 | 1.000 | 0.439 | 1.000 |
| | Specificity | 34 | 0.914 | 0.776 | 0.970 |
| 50 - 70 | Sensitivity | 33 | 0.970 | 0.847 | 0.995 |

Table 1: Gender

0.924

0.970

66

33

0.835

0.847

0.967

0.995

Specificity

Sensitivity

>70

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| Age | Measure | N | Estimate | Lower 95%<br>CI | Upper 95%<br>CI |
|-----|-------------|----|----------|-----------------|-----------------|
| | Specificity | 66 | 0.924 | 0.835 | 0.967 |

| Mfr | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|---------|-------------|----|----------|--------------|--------------|
| GE | Sensitivity | 41 | 0.976 | 0.874 | 0.996 |
| GE | Specificity | 51 | 0.882 | 0.766 | 0.945 |
| TOSHIBA | Sensitivity | 21 | 0.952 | 0.773 | 0.992 |
| TOSHIBA | Specificity | 58 | 0.966 | 0.883 | 0.990 |
| SIEMENS | Sensitivity | 16 | 0.938 | 0.717 | 0.989 |
| SIEMENS | Specificity | 43 | 0.860 | 0.727 | 0.934 |

## Table 3: Scanner Brand

### Table 4: Slice Thickness

| Slice Thickness | Measure | N | Estimate | Lower 95%<br>CI | Upper 95%<br>CI |
|-----------------|-------------|-----|----------|-----------------|-----------------|
| <1.5 | Sensitivity | 96 | 0.931 | 0.836 | 0.973 |
| | Specificity | 150 | 0.910 | 0.838 | 0.952 |
| ≥1.5 | Sensitivity | 54 | 0.978 | 0.924 | 0.994 |
| | Specificity | 6 | 0.842 | 0.726 | 0.915 |

## Table 5: Detector Rows

| Rows | Measure | N | Estimate | Lower 95%<br>CI | Upper 95%<br>CI |
|---------|-------------|----|----------|-----------------|-----------------|
| Unknown | Sensitivity | 2 | 1.000 | - | - |
| | Specificity | 0 | - | - | - |
| 16 | Sensitivity | 3 | 1.000 | 0.439 | 1.000 |
| | Specificity | 0 | - | - | - |
| 64 | Sensitivity | 52 | 0.942 | 0.844 | 0.980 |
| | Specificity | 39 | 0.769 | 0.617 | 0.874 |
| 80 | Sensitivity | 3 | 1.000 | 0.439 | 1.000 |
| | Specificity | 57 | 0.982 | 0.907 | 0.997 |
| 128 | Sensitivity | 4 | 1.000 | 0.510 | 1.000 |
| | Specificity | 28 | 0.786 | 0.605 | 0.898 |
| 256 | Sensitivity | 65 | 0.969 | 0.895 | 0.992 |
| | Specificity | 20 | 0.950 | 0.764 | 0.991 |
| 320 | Sensitivity | 18 | 0.944 | 0.742 | 0.990 |
| | Specificity | 1 | 0.000 | - | - |
| 382 | Sensitivity | 3 | 1.000 | 0.439 | 1.000 |
| | Specificity | 11 | 1.000 | 0.741 | 1.000 |

# Table 6: Scanner Mix w/Convolution Kernel Type

| Manufacturer | Reconstruction Method | N | % of Total |
|--------------------|-----------------------|-----|------------|
| GE MEDICAL SYSTEMS | STANDARD | 84 | 27.4% |
| Manufacturer | Reconstruction Method | N | % of Total |
| | FC08 | 2 | 0.7% |
| | SOFT | 1 | 0.3% |
| | B40s | 1 | 0.3% |
| | B | 1 | 0.3% |
| | ['Br38f', '2'] | 1 | 0.3% |
| | Missing | 2 | 0.7% |
| SIEMENS | ['Br38f', '2'] | 14 | 4.6% |
| | Tr20f | 14 | 4.6% |
| | ['Br40d', '3'] | 4 | 1.3% |
| | Br36f | 3 | 1.0% |
| | FC08 | 3 | 1.0% |
| | STANDARD | 2 | 0.7% |
| | ['Br40d', '2'] | 2 | 0.7% |
| | ['Bv36d', '3'] | 2 | 0.7% |
| | B31s | 2 | 0.7% |
| | B26s | 1 | 0.3% |
| | B30f | 1 | 0.3% |
| | B40s | 1 | 0.3% |
| | B70s | 1 | 0.3% |
| | B | 1 | 0.3% |
| | ['Bf37f', '3'] | 1 | 0.3% |
| | ['Br36f', '3'] | 1 | 0.3% |
| | ['Br38f', '3'] | 1 | 0.3% |
| | Missing | 7 | 2.3% |
| Toshiba | FC08 | 54 | 17.6% |
| | FC14 | 11 | 3.6% |
| | FC02 | 2 | 0.7% |
| | FC18 | 2 | 0.7% |
| | STANDARD | 1 | 0.3% |
| | C | 1 | 0.3% |
| | B | 1 | 0.3% |
| | Missing | 6 | 2.0% |
| Other | Other | 75 | 24.3% |
| Totals | All | 306 | 100.0% |

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## Prescriptive Statement:

Caution: Federal law restricts this device to sale by or on the order of a physician.

# Safety & Effectiveness:

Rapid has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid System performance has been validated with phantom and case data.

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## Conclusion:

In conclusion, the iSchemaView Rapid PETN device is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate device, Briefcase (K190072).