aetherSlide is a software-only device intended for viewing and managing 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. aetherSlide is not intended for use with frozen section, 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. aetherSlide is intended for use with the Philips Ultra Fast Scanner (UFS) and the Philips PS27QHDCR monitor.

Device Description

aetherSlide, version 101692 is a web-based, software only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue obtained from Philips Ultra Fast Scanner (UFS). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the aetherSlide device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pixel-wise comparison (Image Fidelity): Images reproduced by aetherSlide should be visually adequate.	The 95th percentile of pixel-wise differences between aetherSlide and PIPS IMS was less than 3 CIEDE2000, indicating pixel-wise identical output images, and color images were visually adequate.
Turnaround time - Case Selection: Not longer than 10 seconds until the image is fully loaded after selecting a case.	Turnaround times for opening an image were determined and found to be adequate for the intended use.
Turnaround time - Panning: Not longer than 7 seconds until the image is fully loaded when panning one-quarter of the monitor.	Turnaround times for panning were determined and found to be adequate for the intended use.
Measurements (Accuracy): Perform accurate measurements.	Measurement accuracy was verified using a scanned image of a grid micrometer and found to be accurate for the intended use.
Usability: Safe and effective for intended users, uses, and use environments.	The usability test demonstrated the subject device is safe and effective for the intended users, uses, and use environments.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The pixel-wise comparison mentions "the same iSyntax file" but does not quantify the number of such files or cases used. Similarly, for turnaround time, measurements, and usability, specific sample sizes are not provided.
- Data Provenance: Not explicitly stated. The document mentions the device is intended for use with "scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue" obtained from the Philips Ultra Fast Scanner (UFS). This implies the data would be clinical pathology slides, but their origin (country, retrospective/prospective collection) is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are primarily technical performance assessments (pixel comparison, turnaround time, measurement accuracy, usability) rather than diagnostic accuracy studies requiring expert consensus as ground truth. The "ground truth" for these tests would be the reference values or expected outcomes based on the technical specifications of the images or system.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as the studies are focused on technical performance rather than diagnostic outcomes.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The aetherSlide is described as a "software-only device intended for viewing and managing digital images... It is an aid to the pathologist to review, interpret and manage digital images...". It is a WSI viewer and manager, not an AI-assisted diagnostic tool designed to improve human reader performance (e.g., by detecting abnormalities). Therefore, this type of study would not be applicable for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, standalone technical performance assessments were done. The pixel-wise comparison, turnaround time tests, and measurement accuracy tests are evaluations of the algorithm's direct performance in rendering images, speed, and accuracy, independent of a pathologist's diagnostic performance. The usability testing, while involving human users, focuses on the system's interface and interaction, not diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Technical Reference Standards:
  - Pixel-wise comparison: The ground truth was the image reproduced by the predicate device (Philips IntelliSite Pathology Solution - PIPS IMS) for the same iSyntax file.
  - Turnaround time: The ground truth was the pre-defined target times (10 seconds for case selection, 7 seconds for panning).
  - Measurements: The ground truth was the known dimensions on a "scanned image of the grid micrometer."
  - Usability: The ground truth would be the safety and effectiveness criteria outlined in the usability engineering guidance (e.g., task completion rates, error rates, user feedback conforming to safety and effectiveness).
The sample size for the training set:
- The document does not mention a training set size. The aetherSlide is a viewer and management software, not a machine learning model that typically requires a dedicated training set. Its functionality is based on rendering and interacting with existing digital slide images.
How the ground truth for the training set was established:
- As there is no mention of a machine learning component or a training set for diagnostic purposes, the concept of establishing ground truth for a training set is not applicable to the information provided.

Summary

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May 30, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

AetherAI Co., Ltd. Leticia Hong Team Leader of RA 15F & 15F-1., No. 508, Sec. 7 Zhongxiao E. Rd., Nangang Dist. Taipei City. 115011 Taiwan

Re: K233126

Trade/Device Name: aetherSlide Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: September 15, 2023 Received: September 27, 2023

Dear Leticia Hong:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shyam Kalavar -S

Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K233126

Device Name aetherSlide

Indications for Use (Describe)

For In Vitro Diagnostic Use

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Date of Summary: 05/30/2024

1. Submitter: aetherAI Co., Ltd.

Address:	15F & 15F-1, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City 115011, Taiwan (R.O.C.)
Phone:	+886-2-27856892
Contact:	Leticia Hong (leticiahong@aetherai.com)

3. Identification of the Subject Device:

Proprietary/Trade Name:	aetherSlide
Version:	101692
Classification Product Code:	QKQ
Regulation Number:	21 CFR 864.3700
Regulation Description:	Digital Pathology Image Viewing andManagement Software
Review Panel:	88 - Pathology
Device Class:	II
510 (k) SubmissionNumber:	K233126

4. Identification of the Predicate Device:

Predicate Device Name:	Philips IntelliSite Pathology Solution(PIPS)
Applicant:	Philips Medical Systems Nederland B.V
Classification Product Code:	PSY
Regulation number:	21 CFR 864.3700
Device Class:	II
Submission Number:	DEN160056

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ട. Indications for Use / Intended Use of the Device

For In Vitro Diagnostic Use

6. Description of the Device

aetherSlide is operated as follows:

1. Image acquisition is performed using the Philips UFS. The operator conducts quality control of the digital slides according to Philips UFS instructions and laboratory specifications to determine if re-scans are necessary.
Once the WSI is acquired using Philips UFS, it becomes available in the 2. Philips IntelliSite Pathology Solution (PIPS) database file systems. The operator then exports the WSI in iSyntax format from PIPS Image Management System (IMS) to a designated storage path.
1. The operator can manually upload the exported WSI into aetherSlide via

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aetherSlide Gateway, which is a separate medical image communications software. Alternatively, the aetherSlide Gateway can automatically initiate the upload of the WSI into aetherSlide when the auto-upload function is activated on the settings page of aetherSlide Gateway. Once the WSI is uploaded, the reading pathologist uses the device to perform the following actions:

. View slide image
. Zoom and pan the image
Measure distances in the image
. Annotate the image
1. After viewing all images for a patient (case), the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).

aetherSlide is designed to be deployed to a customer-managed infrastructure and may be accessed on the user's workstation browser. aetherSlide operates with and is validated for use with the components specified the tables below:

Components	Manufacturer	Model
Scanner	Philips MedicalSystems NederlandB.V.	Ultra Fast Scanner
Display	Philips MedicalSystems NederlandB.V.	PS27QHDCR Monitor

Table 1. Interoperable Components for Use with aetherSlide

Table 2. Computer Environment/Svstem Requirements
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Environment	Component	Minimum Requirements
Client PC
Hardware	Processor	Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores
	Memory	4 GB RAM or higher
	Storage	128 GB SSD or higher
	Network	100 Mbps Ethernet or above

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Environment	Component	Minimum Requirements
Software	Operating System	Microsoft Windows 11
	Browser	Google Chrome (122 or higher)
Gateway Workstation
Hardware	Processor	Intel or AMD with 64-bit support, at least 2 GHz, at least 2 cores
	Memory	4 GB RAM or higher
	Storage	128 GB SSD or higher
	Network	100 Mbps Ethernet or above
Software	Operating System	Microsoft Windows 11
Server
Hardware	Processor	Intel or AMD with 64-bit support, at least 2 GHz, at least 8 cores
	Memory	16 GB RAM or higher
	Storage	512 GB SSD or higher
	Network	1 Gbps or above
Software	Operating System	Ubuntu 22.04 LTS

7. Summary of Performance Testing

A series of tests were performed to assess the safety and effectiveness of aetherSlide. All the test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use.

The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)''

Test	Result
Pixel-wise comparison	Pixel-wise comparison study was conducted to compare images reproduced by aetherSlide and PIPS IMS for the same iSyntax file to validate identical image reproduction. Test results showed that the 95th percentile of pixelwise differences between aetherSlide and PIPS IMS was less than 3 CIEDE2000, indicating that their output images

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	are pixel-wise identical. Therefore, it wasdetermined that color images reproduced byaetherSlide were visually adequate with respect toits intended use.
Turnaround time	The system requirements have been fulfilled:· When selecting a case, it should not take longerthan 10 seconds until the image is fully loaded.· When panning the image (one quarter of themonitor) it shall not take longer than 7 secondsuntil the image is fully loaded.Turnaround times for opening an image andpanning have been determined and found to beadequate for the intended use of the subjectdevice.
Measurements	Measurement accuracy has been verified using ascanned image of the grid micrometer. aetherSlidehas been found to perform accurate measurementswith respect to its intended use.
Usability testing	The usability test was conducted per FDAguidance “Applying Human Factors and UsabilityEngineering to Medical Devices (2016)”. The testresult demonstrated that the subject device hasbeen found to be safe and effective for theintended users, uses, and use environments.

8. Substantial Equivalence Determination

The aetherSlide submitted in this 510(k) file is substantially equivalent in intended use, safety and performance claims to the cleared device, Philips IntelliSite Pathology Solution (PIPS) (DEN160056).

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Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	aetherAI Co., Ltd.	Philips Medical Systems Nederland B.V.
Trade Name	aetherSlide	Philips IntelliSite Pathology Solution (PIPS)
Submission No.	K233126	DEN160056
Indications forUse/Intended Use	For In Vitro Diagnostic UseaetherSlide is a software-only device intendedfor viewing and managing digital images ofscanned surgical pathology slides preparedfrom formalin-fixed paraffin embedded(FFPE) tissue. It is an aid to the pathologist toreview, interpret and manage digital images ofpathology slides for primary diagnosis.aetherSlide is not intended for use with frozensection, cytology, or non-FFPEhematopathology specimens.It is the responsibility of a qualifiedpathologist to employ appropriate proceduresand safeguards to assure the quality of theimages obtained and, where necessary, useconventional light microscopy review whenmaking a diagnostic decision. aetherSlide is	The Philips IntelliSite Pathology Solution(PIPS) is an automated digital slide creation,viewing, and management system. The PIPSis intended for in vitro diagnostic use as an aidto the pathologist to review and interpretdigital images of surgical pathology slidesprepared from formalin-fixed paraffinembedded (FFPE) tissue.The PIPS is not intended for use with frozensection, cytology, or non FFPEhematopathology specimens. The PIPScomprises the Image Management System(IMS), the Ultra Fast Scanner (UFS) andDisplay. The PIPS is for creation and viewingof digital images of scanned glass slides thatwould otherwise be appropriate for manualvisualization by conventional light
Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	aetherAI Co., Ltd.	Philips Medical Systems Nederland B.V.
Trade Name	aetherSlide	Philips IntelliSite Pathology Solution (PIPS)
Submission No.	K233126	DEN160056
	intended for use with the Philips Ultra FastScanner (UFS) and the Philips PS27QHDCRmonitor.	microscopy. It is the responsibility of aqualified pathologist to employ appropriateprocedures and safeguards to assure thevalidity of the interpretation of imagesobtained using PIPS.
Specimen Type	Digitized surgical pathology slides preparedfrom FFPE tissue	Surgical pathology slides prepared from FFPEtissue	SimilarThe specimen type of thesubject device is the digitizedslides, which is obtained fromthe PIPIS UFS, and thepredicate device includes thecreation of digital imagesused PIPS UFS. Thus, theequivalence would not beaffected.
Image File Format	iSyntax	iSyntax	Same
ImageManipulation	Panning, zooming, color manipulationfunction, annotations, and measurements	Panning, zooming, color manipulationfunction, annotations, and measurements	SimilarThe performance of the
Item	Subject Device	Predicate Device	Substantial Equivalence Discussion
Manufacturer	aetherAI Co., Ltd.	Philips Medical Systems Nederland B.V.
Trade Name	aetherSlide	Philips IntelliSite Pathology Solution (PIPS)
Submission No.	K233126	DEN160056
Functions	(only for distance)	(distance & area)	subject device is not affectedand meet the requirements.Thus, it would not affect theequivalence.
Type of SoftwareApplication	Internet browser-based application	Internet browser-based application	Same
DeviceComponents	aetherSlide imaging viewing software,aetherSlide Gateway	Ultra Fast Scanner (UFS), ImageManagement System (IMS), Display	SimilarThe aetherSlide Gateway isused for uploading the slideinto aetherSlide. Thisdifference would not affectthe performance of thesubject device and itsequivalence.
Principle ofOperation	After WSI images are successfully acquiredby using PIPS UFS, the WSI images are storedin the image storage provided by the end user.During review, the pathologist opens WSI	After WSI images are successfully acquiredby using PIPS UFS, the WSI images are storedin IMS Application Server & Storage softwarethat is not provided as part of the PIPS, but	SimilarThe performance of thesubject device is not affectedand meet the requirements
Item	Subject Device	Predicate Device	Substantial EquivalenceDiscussion
Manufacturer	aetherAI Co., Ltd.	Philips Medical Systems Nederland B.V.
Trade Name	aetherSlide	Philips IntelliSite Pathology Solution (PIPS)
Submission No.	K233126	DEN160056
	images from storage, performs further QC andreads WSI images of the slides to make adiagnosis.	may be located in a central server roomseparate from the workstation with the IMSviewing software and Display. During review,the pathologist opens WSI images from IMSServer & Storage, perform further QC andreads WSI images of the slides to make adiagnosis.	Thus, it would not affect theequivalence.
Image Storage	Images are stored in an end user providedimage storage attached to the local network.	Images are stored in the end user providedimage storage (PIPS IMS Application Server& Storage) attached to the local network.	SimilarThe performance associatedwith image storage of subjectdevice is not affected andmeet the requirements. Thus,it would not affect theequivalence.

Table 3. Summary of Technological Characteristics

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9. Similarity and Difference

The subject device has similar indications for use/intended use, similar technology/principle of operation, technological characteristics, and safety and performance to the predicate device, when used with the PIPS UFS scanner and the Philips PS27QHDCR monitor.

However, there is slight difference between the subject device and the predicate device which include the following aspect:

. Medical image communication software
Once a slide image is acquired using PIPS UFS, according to its Instructions for Use, and becomes available in scanner database file systems, aetherSlide contains a Gateway which will automatically initiate uploading the slide image and corresponding metadata to the storage (not part of the device), or allow the operator to manually upload the slide image via aetherSlide Gateway. aetherSlide Gateway will perform integrity checks at the time of upload when data is copied to storage.

Nevertheless, verification activities were conducted on the subject device, and all tests were verified to meet the required acceptance criteria. The result of the verification tests indicated that aforementioned differences do not affect the indications for use/intended use of the subject device or raise any unresolved issues. Consequently, any differences between the subject device and the predicate device are insignificant and do not present any substantial equivalence concerns. The subject device is substantially equivalent to the predicate device as claimed.

10. Conclusion

After analyzing non-clinical safety and performance testing data, it can be concluded that when aetherSlide is used with the PIPS UFS scanner and the Philips PS27QHDCR monitor, it is substantially equivalent to the predicate device.

Regulation Number and Section

§ 864.3700 Whole slide imaging system.

(a)
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.(b)
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.