← Product Code [QKQ](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/QKQ) · K210811 # Dynamyx Digital Pathology Software (K210811) _Inspirata, Inc. · QKQ · Mar 1, 2022 · Pathology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/QKQ/K210811 ## Device Facts - **Applicant:** Inspirata, Inc. - **Product Code:** [QKQ](/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/QKQ.md) - **Decision Date:** Mar 1, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.3700 - **Device Class:** Class 2 - **Review Panel:** Pathology - **Attributes:** Software as a Medical Device ## Indications for Use Dynamyx Digital Pathology Software is 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 and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor. ## Device Story Client-server software for viewing/managing whole slide images (WSI) from Leica Aperio AT2 DX or Philips Ultra-Fast Scanner; imports images into Dynamyx Digital Archive; uses lossless compression for display. Pathologists use Installed Client or Web Client to pan, zoom, measure, and annotate images for primary diagnosis. Histology technicians perform initial QC to confirm image quality before pathologist review. System provides visual indicators for diagnostic status. Benefits include standardized digital workflow, remote access to cases, and integrated tools for measurement/annotation to support diagnostic accuracy. ## Clinical Evidence No clinical data. Bench testing only: pixel-wise comparison of 33 FFPE slides (60 image pairs per configuration) demonstrated identical reproduction (zero ΔE) compared to predicates. Turnaround time, measurement accuracy (within 5%), and summative human factors/usability testing were performed. ## Technological Characteristics Client-server software; standalone medical device. Supports Leica Aperio AT2 DX and Philips Ultra Fast Scanner inputs. Connectivity: local network image storage. Display: indicated for use with Dell MR2416 and Philips PP27QHD monitors. Functions: image decoding, lossless compression, panning, zooming, annotation, measurement. No hardware included. ## Regulatory 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](/device/DEN160056.md)) - Aperio AT2 DX System ([K190332](/device/K190332.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY ## I Background Information: A 510(k) Number K210811 B Applicant Inspirata, Inc. C Proprietary and Established Names Dynamyx Digital Pathology Software 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. B Indication(s) for Use: Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} Dynamyx Digital Pathology Software is 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 and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips Ultra Fast Scanner and Philips PP27QHD monitor. ## C Special Conditions for Use Statement(s): Rx - For Prescription Use Only ## IV Device/System Characteristics: ## A Device Description: Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips IntelliSite Pathology Solution (PIPS) Ultra-Fast Scanner (UFS). Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the image to the Dynamyx viewers. Whole slide images are viewed in the Dynamyx image viewer window by pathologists for the purposes of making a primary diagnosis. The pathologist can also navigate (pan and zoom) and annotate the images. Dynamyx incorporates typical histology/pathology workflow and is operated as follows: 1. The subject device receives whole slide images from the scanner and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g., the pixel size) is stored in the subject device's database to increase the operational performance (e.g., response times) of Dynamyx. 2. Whole slide images are reviewed first by the scanning technician such as a histologist to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review quality control (QC) status determined by the scanning technician indicates which whole slide images have been reviewed and have passed QC. The QC status is available to the reading pathologist. K210811 - Page 2 of 10 {2} 3. The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive. 4. The reading pathologist uses Dynamyx to view and perform the following actions on the displayed image: a. Zoom and pan the image b. Adjust the apparent image observed magnification level c. Measure distances and areas d. Annotate images and cases 5. The above steps are repeated as required. After viewing all images, the pathologist will render a diagnosis which is documented in a laboratory information system. # Minimum System Requirements - Computer Environment The system requirements are given in Tables 1 through 2d below. Table 1: WSI scanners and displays that can be used with Dynamyx Digital Pathology Software | Manufacturer | Model | | --- | --- | | Philips Medical Systems Nederland B.V. | Scanner: Ultra-Fast Scanner (UFS) | | | Display: MMPC-4127F1/PP27QHD | | Leica Biosystems Imaging, Inc. | Scanner: Aperio AT2 DX Slide | | | Display: MR2416 (Dell) | Note: Philips PP27QHD monitor must be used with Philips Ultra-Fast Scanner and Dell MR2416 monitor must be used with Leica Aperio AT2 DX Scanner. The monitors are not interchangeable. Table 2a: Computer environment minimum requirements for Dynamyx Digital Pathology Software, Dynamyx Server | Hardware | Server | vCPU | Memory | Drives | | --- | --- | --- | --- | --- | | | Workflow Server | 2 cores | Total - 8 GB | C Drive - 200 GB | | | SQL Server | 2 cores | Total - 8 GB | C Drive - 200 GB E Drive - 600 GB F Drive - 600 GB | | | Digital Archive Server | 8 cores | Total - 16 GB | C Drive - 200 GB E Drive - 200 GB F Drive - Image Store (Drive of appropriate size) | | | Web Server | 2 cores | Total - 8 GB | C Drive - 200 GB E Drive - 25 GB | | | Job Agent Server | 4 cores | Total - 8 GB | C Drive - 200 GB | K210811 - Page 3 of 10 {3} Table 2b: Computer environment minimum requirements for Dynamyx Digital Pathology Software, Histology Workstation | Software | Component | Specifications/Application | Comments | | --- | --- | --- | --- | | | Processor | Intel i5 or greater | N/A | | Hardware | Memory | 8 GB RAM | N/A | | | Internal Storage | 7200 RPM or faster disks or SSD | Space requirements are nominal (<10GB) | | | Network Connectivity | 100 Mbps Full Duplex | 1Gbps preferred | | | Video Adapter | Web GL compatible | N/A | | | Display | If Leica scanner, then use Dell MR2416 display | Required for Image QC review | | | Display | If Philips scanner, then use PP27QHD display | | | Software | Operating System | Windows 10 | Latest patches recommended | Table 2c: Computer environment minimum requirements for Dynamyx Digital Pathology Software, Pathology Workstation (Web based) | Hardware | Component | Specification/Application | Comments | | --- | --- | --- | --- | | | Processor | Intel i5 or greater | N/A | | | Memory | 8 GB RAM | N/A | | | Internal Storage | N/A | N/A | | | Network Connectivity | 100 Mbps Full Duplex | N/A | | | Video Adapter | Web GL compatible | N/A | | | Display | If Leica scanner, then use Dell MR2416 display If Philips scanner, then use PP27QHD display | Required for Diagnostic Use (Dx) | | Software | Operating System | Windows 10 | Latest patches recommended | | | Browser | Chrome | Latest version of browser is recommended | K210811 - Page 4 of 10 {4} Table 2d: Computer environment minimum requirements for Dynamyx Digital Pathology Software, Pathology Workstation (installed) | Hardware | Component | Specification | Comments | | --- | --- | --- | --- | | | Processor | Intel i5 or greater | N/A | | | Memory | 8 GB RAM | N/A | | | Internal Storage | 7200 RPM or faster disks or SSD | Space requirements are nominal (<10GB) | | | Network Connectivity | 100 Mbps Full Duplex | 1Gbps preferred | | | Video Adapter | Web GL compatible | N/A | | | Display | If Leica scanner, then use Dell MR2416 display If Philips scanner, then use PP27QHD display | Required for Diagnostic Use (Dx) | | Software | Operating System | Windows 10 | Latest patches recommended | # B Instrument Description Information: 1. Instrument Name: Dynamyx Digital Pathology Software 2. Specimen Type: Surgical pathology slides prepared from FFPE tissue 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 or Leica Aperio AT2 DX Slide Scanner. 4. Calibration: Not applicable 5. Quality Control: When used as part of the Philips IntelliSite Pathology Solution (PIPS) system, the following QC procedure is used: The scanning technician views slide macro images on the Philips' K210811 - Page 5 of 10 {5} Ultra-Fast Scanner interface to confirm all tissue is contained in the scanned area and then uses the Dynamyx Digital Pathology Software to confirm the scanned image quality (e.g., focus, color, stitch errors, missing tissue). The QC status is available to pathologist. When used with the Leica Aperio AT2 DX System, the following QC procedure is used: The scanning technician views the slide macro image on the Leica system's interface to confirm all tissue is contained in the scanned area and then uses the Dynamyx Digital Pathology Software to confirm the scanned image quality (e.g., focus, color, stitch errors, missing tissue). The QC status is available to pathologist. Refer to the Dynamyx Digital Pathology Software user guide for additional information. ## V Substantial Equivalence Information: ### A Predicate Device Name(s): Philips IntelliSite Pathology Solution (PIPS) Aperio AT2 DX System ### B Predicate 510(k) Number(s): DEN160056 K190332 ### C Comparison with Predicate(s): | Device & Predicate Device(s): | K210811 | DEN160056 | K190332 | | --- | --- | --- | --- | | Device Trade Name | Dynamyx Digital Pathology Software | Philips IntelliSite Pathology Solution (PIPS) | Leica Aperio AT2 DX System | | General Device Characteristics: Similarities | | | | | Intended Use/Indications For Use | Dynamyx Digital Pathology Software is 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 | 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 | The Leica Aperio AT2 DX System is an automated digital slide creation and viewing system. The Leica Aperio AT2 DX System 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 | K210811 - Page 6 of 10 {6} K210811 - Page 7 of 10 | | and interpret these digital images for the purposes of primary diagnosis. Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software. The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica’s Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips’ Ultra Fast Scanner and Philips PP27QHD monitor. | 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 PIPS. | paraffin embedded (FFPE) tissue. The Leica Aperio AT2 DX System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The Leica Aperio AT2 DX System is composed of the Leica Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Leica Aperio AT2 DX System 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 the Leica Aperio AT2 DX System. | | --- | --- | --- | --- | | Specimen Type | Surgical pathology slides prepared from FFPE tissue | Same | Same | | Image Storage | Images are stored in end user provided image storage attached to the local network | Same | Same | | Image Manipulation Functions | Panning, zooming, image adjustments, annotations, and distance/area measurements | Same | Same | | Image Review and Diagnosis | During review, the pathologist opens WSI | Same | Same | {7} K210811 - Page 8 of 10 | | images acquired with the WSI scanner from the image storage, performs further QC and interprets the WSI images to make a diagnosis | | | | --- | --- | --- | --- | | Diagnostic Status of Images | Displays a visual indicator for the diagnostic status of an image | Same | Same | | User Interface | Full-featured image viewer with integrated case list containing slide thumbnails | Same | Same | | General Device Characteristic: Differences | | | | | Device Components | Dynamyx digital pathology software | Ultra-Fast Scanner (UFS), Image Management System (IMS), Display | Aperio AT2 DX scanner, the ImageScope DX review application and Display | VI Standards/Guidance Documents Referenced: 1. Guidance for Industry “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016 2. ANSI AAMI IEC 62304:2006 & A1:2016 - Medical device software - Software life cycle processes 3. ANSI AAMI IEC 62366-1:2015+AMD1:2020 – Application of usability engineering to medical devices 4. ANSI AAMI ISO 14971: 2019 – Applications of risk management to medical devices 5. AAMI TIR 45:2012 - Guidance on the use of AGILE practices in the development of medical device software VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: Not applicable. 2. Linearity: Not applicable. {8} 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 Dynamyx Digital Pathology Software device was performed. The new device was compared to the Image Management Software (IMS) component of the Philips PIPS device and the ImageScope DX viewer software of Leica Aperio AT2 DX System. The following testing was performed: a. Pixel-wise comparison with the predicate device including zooming and panning operations The equivalence between the subject and predicate image review manipulation software (IRMS, as defined in the FDA guidance titled "Guidance for Industry "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016 [TPA guidance, IV(A)(9)] was supported by bench testing data based on pixel-level comparison. The subject IRMS was tested as operating with the intended components, including the scanner, image management system and display. Scanned images from 33 FFPE tissue glass slides from different anatomic locations were used as the test input. For each region of interest (ROI), the differences between the views generated by the subject and predicate IRMS were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric $\Delta E$ for each corresponding pixel pair. The two views generated by the subject and predicate IRMS were adjusted and registered by using only the graphical user interface without image processing. The test cases of ROIs included relevant biological features at different magnification levels such as $40\mathrm{x}$, $20\mathrm{x}$ and $10\mathrm{x}$. Horizontal/vertical stitching seams between the tiles were included in the ROIs when possible. Sixty image pairs at $40\mathrm{x}$, $20\mathrm{x}$, and $10\mathrm{x}$ were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Leica AT2 DX. Similarly, sixty image pairs at $40\mathrm{x}$ and $20\mathrm{x}$ were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Philips PIPS. In addition, sixty image pairs at $40\mathrm{x}$ and $20\mathrm{x}$ were used to test Dynamyx Digital Pathology Software Pathologist Workstation Web Client running in the Chrome browser against Philips PIPS. The color differences of all pixels within each ROI were reported. The image data of all ROIs were also provided for verification. The test results demonstrated that all image pairs are identical with zero $\Delta E$. The subject device has been found to adequately reproduce digital pathology images at the pixel level with respect to its intended use. K210811 - Page 9 of 10 {9} b. Turnaround Time Turnaround time test was performed to verify the streaming indicator functionality and to measure the turnaround time for initial image load, panning via mouse drag and zooming with 10 concurrent users using Leica Aperio AT2 DX scanner images and Philips UFS images. Test results are acceptable. c. Measurement Accuracy Measurement accuracy testing was performed to verify the calculated measurement for each annotation (e.g., length and area) is accurate to within 5% of the reference measurement using a certified micron scale image created using a Leica Aperio AT2 DX scanner and a Philips UFS. Test results showed that the subject device performed accurate measurements with respect to its intended use. d. Human Factors (Usability) Testing Formative and summative usability testing was conducted on the Dynamyx Pathology Workstation and the Histologist Workstation interfaces in accordance with FDA Guidance on "Applying Human Factors and Usability Engineering to Medical Devices. 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 were 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. K210811 - Page 10 of 10 --- **Source:** [https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/QKQ/K210811](https://fda.innolitics.com/submissions/PA/subpart-d%E2%80%94pathology-instrumentation-and-accessories/QKQ/K210811) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com