Novo

K212361 · PathAI, Inc. · QKQ · Aug 11, 2022 · Pathology

Device Facts

• Record ID: K212361
• Device Name: Novo
• Applicant: PathAI, Inc.
• Product Code: QKQ · Pathology
• Decision Date: Aug 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.

Device Story

Novo is a web-based, software-only viewer for digital whole slide images (WSIs) of FFPE surgical pathology slides. Input consists of WSIs acquired via Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner, uploaded to cloud storage. The device transforms these inputs into a web-based interface allowing pathologists to zoom, pan, and manage images for primary diagnosis. Used in clinical settings by pathologists; requires internet access and specific calibrated displays (Barco PP27QHD or Philips PS27QHDCR). Output is a digital image display used by the pathologist to render a diagnosis. The device facilitates remote or digital review, potentially improving workflow efficiency compared to traditional light microscopy while maintaining diagnostic accuracy.

Clinical Evidence

Clinical study compared manual digital (MD) reads using Novo to manual optical (MO) reads using light microscopy against original sign-out diagnosis (ground truth). Primary endpoint: difference in major discordance rates. Results: difference in major discordance rates between MD and GT vs. MO and GT was -0.1% (95% CI: -2.05, 1.78). The upper limit (1.78%) was below the 4% non-inferiority threshold. Bench testing confirmed image reproduction similarity to JPEG-compressed PIPS/IMS images.

Technological Characteristics

Web-based software-only viewer. Operates on standard PC hardware (4GB RAM, Chrome browser). Displays: Color LCD, IPS technology, a-Si Thin Film Transistor, 2560x1440 resolution. Connectivity: Cloud-based, requires 25 Mbps internet, port 443. Image format: DZI (converted from Philips iSyntax).

Indications for Use

Indicated for pathologists to view, interpret, and manage digital images of FFPE surgical pathology slides for primary diagnosis. Not for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

Regulatory Classification

Identification

The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.

Special Controls

A whole slide imaging system must comply with the following special controls: (1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics: (D)Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G)Image composition techniques; (H)Image file formats; (I) Image review manipulation software; (J) Computer environment; (K)Display system. (iii)Detailed bench testing and results at the system level, including for the following, as appropriate: (A)Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error: (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A)Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (e.g., main sign-out diagnosis). (D) A detailed human factors engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: The intended use statement must include the information described in paragraph (i) (1)(i) of this section, as applicable, and a statement that reads, "It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device." (ii) A description of the technical studies and the summary of results, including those that relate to paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information: (i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system. (ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate: (A) Slide feeder; (B) Light source; (C) Imaging optics; (D) Mechanical scanner movement; (E) Digital imaging sensor; (F) Image processing software; (G) Image composition techniques; (H) Image file formats; (I) Image review manipulation software; (J) Computer environment; and (K) Display system. (iii) Detailed bench testing and results at the system level, including for the following, as appropriate: (A) Color reproducibility; (B) Spatial resolution; (C) Focusing test; (D) Whole slide tissue coverage; (E) Stitching error; and (F) Turnaround time. (iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate: (A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included. (C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference ( *e.g.,* main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s). (2) Labeling compliant with 21 CFR 809.10(b) must include the following: (i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.” (ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate. (iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.

Predicate Devices

• Philips IntelliSite Pathology Solution (PIPS) (DEN160056)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

# INSTRUMENT ONLY

I Background Information:

A 510(k) Number

K212361

B Applicant

PathAI, LLC

C Proprietary and Established Names

Novo

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QKQ | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |

II Submission/Device Overview:

A Purpose for Submission:

New device

B Type of Test:

Not applicable – software only device

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) for Use:

Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. Novo is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner and the Barco PP27QHD or Philips PS27QHDCR display.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

IV Device/System Characteristics:

A Device Description:

Novo is a web-based software-only device that is intended to aid pathology professionals in the viewing, interpretation, and management of digital whole slide images (WSIs) of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue using the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS). Novo functionalities include image upload, image management, image conversion and viewing WSIs.

Novo is operated as follows:

1. The user prepares and scans slides and reviews the slide quality in accordance with the PIPS UFS indication for use (IFU) and any other laboratory specific procedures.
2. The user uploads WSIs to cloud storage using Novo and builds a patient accession using the patient's medical record number (MRN), date of birth (DOB) and accession ID to support linkage of one or more slides from a single procedure using patient identifiers in Novo.
3. Once slide image is acquired using PIPS UFS according to its IFU and becomes available in scanner database file systems, Novo will automatically initiate uploading the slide image (using Novo uploader) and corresponding metadata to persistent cloud storage. Integrity checks are performed at upload time when data is copied to storage. During review, the pathologist opens WSI images from storage [displayed as Deep Zoom Image (DZI) images] using Novo, performs further QC and reads WSI images of the slides to make a primary diagnosis. The workflow of a pathologist includes zooming and panning images.

After viewing all images belonging to a particular accession, the pathologist renders a diagnosis.

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Novo operates with the following components:

Table 1: WSI Scanner and Displays

| Manufacturer | Model |
| --- | --- |
| Philips Medical Systems Nederland B.V. | Ultra-Fast Scanner (UFS) |
| Barco N.V. Display | PP27QHD |
| Philips Display | PS27QHDCR |

Table 2: Computer Environment/System Requirements

| System | Details |
| --- | --- |
| Computer System | RAM: 4.0 GB
Display Calibration tool: MediCal QAWeb Agent for Philips and Barco Displays |
| Display | Barco (PP27QHD) or Philips (PS27QHDCR)
Pixel resolution: 2560w x 1440h
Panel type: Color LCD
Technology: IPS technology with a-Si Thin Film Transistor
Physical size: 648.5 mm x 423 mm x 91.3 mm (with backlight disc) |
| Web Browser | Google Chrome 81.0 or later. |
| Network | Internet access
Outbound traffic enabled to port 443
25 Mbps download and upload speed |

C. Instrument Description Information:

1. Instrument Name:
Not applicable – software only device

2. Specimen Identification:
Novo uses digital pathology images obtained from the PIPS UFS of Hematoxylin and Eosin (H&E) stained glass slides. The reading pathologist selects a case (patient) from a worklist external to the subject device whereby the subject device fetches the associated images from the external image storage. The scanned images are identified based on the previously assigned specimen identifier.

3. Specimen Sampling and Handling:
Specimen sampling and handling are performed upstream and independent of the use of the subject device. Specimen sampling includes biopsy or resection specimens which are processed using histology techniques. The FFPE tissue section is H&E stained. Digital images are them obtained from these glass slides using the PIPS UFS.

4. Calibration:
Not applicable

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5. Quality Control:
Before reading pathology images using the Novo device, the pathologist should ensure that all scanned slide images have been imported and for every case, view the thumbnails in the pathology image window to verify that each slide that should be in the case is present (manually verifying tissue block and staining information from LIS).

V Substantial Equivalence Information:

A Predicate Device Name(s):
Philips IntelliSite Pathology Solution (PIPS)

B Predicate 510(k) Number(s):
DEN160056

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K212361 | DEN160056 |
| --- | --- | --- |
| Device Trade Name | Novo | Philips IntelliSite Pathology Solution (PIPS) |
| General Device Characteristic: Similarities | | |
| Intended Use/Indications For Use | Novo is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of pathology slides for primary diagnosis.
Novo is not intended for use with frozen sections, cytology, or non-FFPE, hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. Novo is intended for use with the Philips Ultra Fast Scanner | The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using |

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| | and the Barco PP27QHD or Philips PS27QHDCR display. | PIPS. |
| --- | --- | --- |
| Image File Format | Philips UFS iSyntax File converted to device specific image format | Philips UFS iSyntax File |
| Internet Browser Based | Google Chrome | Same |
| **General Device Characteristic: Differences** | | |
| Image Manipulation Functions | Panning, zooming, notes | Panning, zooming, color manipulation function, annotations, and measurements (distance & area) |
| Device Components | Image viewing software | Ultra Fast Scanner (UFS), Image Management System (IMS), Display |
| Principle of Operation | After WSI images are successfully acquired by using PIPS UFS, the WSI images and are stored in the cloud. During review, the pathologist opens WSI images from storage (displayed as DZI images), performs further QC and reads WSI images of the slides to make a diagnosis. | After WSI images are successfully acquired by using PIPS UFS, the WSI images are stored in IMS Application Server & Storage software that is not provided as part of the PIPS but may be located in a central server room separate from the workstation with the IMS viewing software and Display. During review, the pathologist opens WSI images from IMS Server & Storage, perform further QC and reads WSI images of the slides to make a diagnosis. |
| Image Storage | Images are stored in the cloud | Images are stored in an end user provided image storage (PIPS IMS Application Server & Storage) attached to the local network |

VI Standards/Guidance Documents Referenced:

1. ANSI AAMI ISO 14971:2019, Medical devices – Applications of risk management to medical devices
2. IEC 62304:2006/AMD 1:2015, Medical Device Software – Software Life Cycle Processes
3. IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical devices
4. IEC 82304-1:2016, Health software – Part 1: General requirements for product safety

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

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Not applicable

2. Linearity:
Not applicable

3. Analytical Specificity/Interference:
Not applicable

4. Accuracy (Instrument):
Not applicable

5. Carry-Over:
Not applicable

## B Other Supportive Instrument Performance Characteristics Data:

Technical performance testing for Novo device was performed. The new device was compared to the image management software component of the predicate device. The following testing was performed:

### a. Bench Testing – Pixel-wise comparison test

A pixel-wise comparison test was performed to compare images reproduced by Novo and PIPS IMS for the same iSyntax file to demonstrate identical image reproduction. Thirty H&E-stained FFPE glass slides from various organs and tissue types were used in this test. The slides were scanned with the PIPS UFS, and each slide image was read by a qualified pathologist to choose three regions of interest (ROIs) that included relevant, biologically representative anatomical features. Each ROI was selected with the relevant features placed at the center at magnification levels 20x and 40x. A total of 180 ROIs were made available for both PIPS IMS and Novo to display on the screen using the default settings.

Cypress, a JavaScript-based end-to-end testing framework, was used to capture the screenshots. The Cypress built-in screenshot functionality captured the image sized 1458 pixels by 897 pixels by specifying the HTML canvas element that was displayed. The captured screenshots were then aligned and converted to RGB pixel data using the python imaging library Pillow.

The RGB pixel data was bound to the sRGB color space and converted to the CIELAB color space. The color difference of each corresponding pixel-pair was calculated using the CIEDE2000 ($\Delta E_{00}$) formula for further analysis.

For each ROI, the $\Delta E_{00}$ histogram was calculated as well as its cumulative distribution function, which allows for observation of many statistical results such as maximum $\Delta E_{00}$, minimum $\Delta E_{00}$, 99-percentile, 4-$\Delta E_{00}$, area-over-the-curve, etc.

Test results show that the color differences ($\Delta E_{00}$) between Novo and PIPS/IMS are not zero. Test results are shown in Table 3 below.

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Table 3: Pixel-Wise Comparison Test Results

| Statistical Results | ΔE00 Value (n=180) |
| --- | --- |
| Minimum Mean | 0.50 |
| Maximum Mean | 1.97 |
| Average Mean | 1.10 |
| Minimum Median | 0.46 |
| Maximum Median | 1.61 |
| Average Median | 0.93 |

Further, testing was conducted to compare Novo-generated images with JPEG-compressed PIPS/IMS-generated images. Test results show that the Novo-generated images are similar to PIPS/IMS-generated images that had been JPEG-compressed at quality 95.

Based on the findings from bench testing, an additional clinical study was performed to establish the safety and effectiveness of the device.

# b. Clinical Study

A clinical study was conducted to demonstrate that viewing, reviewing, and diagnosing WSIs of H&E stained FFPE tissue slides using Novo [manual digital read (MD)] is non-inferior to glass slide reads using optical (light) microscopy [manual optical (MO)]. The primary endpoint of the study was the difference in major discordance rates between MD and MO when compared to the reference (main) diagnosis, which was the original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution.

This study included 264 cases which were representative of the breadth and range of organs, sample types and diagnosis including challenging diagnoses in histopathology. Study cases included one representative H&E slide per case. Slides were scanned using the FDA cleared Philips UFS at $40\mathrm{x}$ magnification at one site and reviewed by the study pathologists at their individual sites using the Novo device and a Barco PP27QHD monitor, as specified by Phillips UFS and Novo IFU. Images were checked for image quality according to scanner instructions before upload to the platform.

Three (3) pathologists read all cases which were deidentified, using MD and MO with a washout of two (2) weeks in between the MD and MO. All 3 reading pathologists read the slides for all cases at their individual sites using both MD and MO. The reading pathologists were provided with 3 batches of slides. A case report form (CRF) was completed to document the reading pathologist's diagnosis for each batch, and each read (MD and MO). Reads from both modalities (MD or MO) were adjudicated by one independent pathologist who was not part of the study to determine agreement with the GT and to each other, using standardized pre-defined definitions of harm as follows: 1) concordant, 2) major discordant or 3) minor discordant.

The primary endpoint was to demonstrate that the proportion of major discordances between diagnosis based on MD and GT diagnosis is no worse than 0.04 above the proportion of major discordances between diagnosis based on MO and GT. The secondary endpoint was to show the observed proportion of concordances between diagnosis based on glass slides and WSI is at least $95\%$ .

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Of the 264 cases, one slide was not available for scanning due to breakage and was excluded from both primary and secondary analysis; a second slide was marked as “adjudication not available” and was excluded from primary analysis; a third slide was excluded from both analysis since the slide ID was not confirmed by one of the pathologists. Therefore, the primary analysis included 261 cases and the secondary analysis included 262 cases.

The differences in major discordance rates between MD and GT compared to MO and GT were -0.1% (95% CI, -2.05, 1.78) for all organs as shown in Table 4 below. The upper limit of the CI for the major discordance rate was 1.78%, which is less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study.

Table 4: Clinical Study Results Based on Major Discordance Rates, all organs

| Modality | (n/N) | Discordance Rate (%) | 95% CI (%) |
| --- | --- | --- | --- |
| MO vs GT | (132/783) | 16.9 | (13.05, 20.79) |
| MD vs GT | (131/783) | 16.7 | (12.86, 20.64) |
| Difference | | -0.1 | (-2.05, 1.78) |

Secondary analysis (Table 5 below) showed the observed proportion of concordances between diagnosis based on MO and MD was 95.7%, which surpasses the secondary objective of concordance between MO and MD of at least 95%.

Table 5: Concordance Rate Between MO and MD

| Modality | (n/N) | Concordance Rate (%) | Bootstrap 95% CI |
| --- | --- | --- | --- |
| MO vs MD | (752/786) | 95.7 | (93.74, 97.35) |

The major discordance rate between MO and MD by organ is shown in Table 6 below.

Table 6: Major Discordance Rates by Organ and Modality

| Organ Type | Major discordance rate | | |
| --- | --- | --- | --- |
| | Manual digital (MD) % (n/N) | Manual optical (MO) % (n/N) | Difference% (MD – MO) |
| Adrenal | 0 (0/3) | 0 (0/3) | 0 |
| Anus | 6.06 (2/33) | 9.09 (3/33) | -3.03 |
| Bladder | 45.83 (11/24) | 45.83 (11/24) | 0 |
| Brain/Neuro | 16.67 (1/6) | 0 (0/6) | 16.67 |
| Breast | 28.33 (34/120) | 25.83 (34/120) | 2.5 |
| Colon | 13.58 (11/81) | 11.11 (9/81) | 2.47 |
| Esophagus/GE Junction | 21.21 (7/33) | 12.12 (4/33) | 9.09 |
| Gynecological/Ovary | 20 (3/15) | 20 (3/15) | 0 |
| Kidney/Neoplastic | 0 (0/21) | 0 (0/21) | 0 |

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| Organ Type | Major discordance rate | | |
| --- | --- | --- | --- |
| | Manual digital (MD) % (n/N) | Manual optical (MO) % (n/N) | Difference% (MD – MO) |
| Liver/BD | 0 (0/6) | 0 (0/6) | 0 |
| Lymph Node | 0 (0/24) | 4.17 (1/24) | -4.17 |
| Oral Cavity | 3.03 (1/33) | 3.03 (1/33) | 0 |
| Pancreas | 16.67 (2/12) | 16.67 (2/12) | 0 |
| Prostate | 19.81 (41/207) | 22.22 (46/207) | -2.42 |
| Respiratory | 0 (0/36) | 0 (0/36) | 0 |
| Salivary Gland | 0 (0/6) | 0 (0/6) | 0 |
| Skin | 9.72 (7/72) | 13.89 (10/72) | -4.17 |
| Soft Tissue (Tumors) | 20 (3/15) | 20 (3/15) | 0 |
| Stomach | 6.67 (1/15) | 6.67 (1/15) | 0 |
| Thyroid | 33.33 (7/21) | 33.33 (7/21) | 0 |

Overall, these results demonstrate that the PathAI Novo image viewer is safe and effective when used by pathologists for primary diagnoses purposes.

## c. Turnaround Time for the image to be fully loaded while opening a slide for panning/zooming

Turnaround time (TAT) testing was performed for WSI file processing and DZI loading, panning, and zooming in the subject device. The subject device demonstrated acceptable turnaround time with respect to its intended use for opening the first image and panning and zooming within the image.

## d. Human Factors testing

Human factors study designed around critical user tasks and use scenarios performed by representative users were conducted. A systematic evaluation of task-based usability including critical tasks required for operation of the device were evaluated at multiple sites using multiple users. All tasks associated with reviewing and reporting results for cases including confirmation that all slides belonging to specific cases are reviewed before reporting results, were included in the study. Overall, the results of the human factors testing are acceptable.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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