MetaLite DX Digital Pathology Software 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 for the purposes of pathology primary diagnosis. It is an aid to the pathologist to review, interpret and manage digital images of pathology slides.

MetaLite DX Digital Pathology Software 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. MetaLite DX Digital Pathology Software is intended for use with Philips Ultra Fast Scanner and the Barco MDPC-8127 display.

Device Description

MetaLite DX Digital Pathology Software, Model MLDXUS, version 1.2.1 is software designed for viewing digital pathology images of glass slides from the Philips IntelliSite Pathology Solution Ultra-Fast Scanner (PIPS-UFS), version 1.8.4 on Barco MDPC-8127 display.

MetaLite DX Digital Pathology Software is operated as follows:

Before scanning the slide on the PIPS-UFS, the technician performs quality control on the tissue of interest. The images captured by the PIPS-UFS are compressed using Philips' proprietary iSyntax format and are transmitted to the Philips Image Management System (IMS).

(1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical interface for the pathologist to view.

(2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas).

(3) 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).

The software has various features such as zoom-in and zoom-out functions, scale display, thumbnail view, measurement function, annotation function, and panning function to help pathologists interpret, diagnose and manage digital whole slide images. The MetaLite DX Digital Pathology Software is validated for use with the components specified the tables below.

AI/ML Overview

Let's break down the acceptance criteria and the study proving the device meets them based on the provided text.

Based on the provided text, the "MetaLite DX Digital Pathology Software" (MLDXUS) is a software-only device intended for viewing and managing digital images of scanned surgical pathology slides for primary diagnosis. The performance testing section describes the studies conducted to demonstrate its safety and effectiveness.

Here's the information organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Pixel-wise comparison	The output images of the MetaLite DX Digital Pathology Software should be visually identical to those produced by the predicate device (PIPS IMS) for the same file.	The 95th percentile of pixel-wise differences between MetaLite DX Digital Pathology Software and PIPS IMS was less than 3 CIEDE2000, indicating that their output images are pixel-wise identical and visually adequate.
Turnaround time	Opening, panning, and zooming an image should be within an adequate timeframe for intended use (implicitly, within 5 seconds based on the outcome).	The turnaround time for opening, panning, and zooming an image is within 5 seconds. This was determined and found to be adequate for the intended use.
Measurements	The software should perform accurate measurements.	Measurement accuracy was verified using a scanned image of a calibration scale slide. MetaLite DX Digital Pathology Software was found to perform accurate measurements with respect to its intended use. (Note: Predicate device also measures area, but this device only explicitly states distance measurement in the comparison table, although the performance statement is general for "measurements").
Usability testing	The device should be safe and effective for its intended users, uses, and use environments.	Conducted per FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)". The test result demonstrated that the subject device has been found to be safe and effective for the intended users, uses, and use environments.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for the test sets used in the pixel-wise comparison, turnaround time, measurement accuracy, or usability testing.

The document does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). It only states that the images used were "iSyntax file generated from UFS 1.8.4," which refers to the Philips Ultra Fast Scanner, a compatible component.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for any of the performance tests.

For the pixel-wise comparison, the ground truth seems to be the output of the predicate device (PIPS IMS) for the same initial image file, rather than expert judgment on clinical images.
For turnaround time and measurements, the ground truth would be objectively measurable (time, known distances on a calibration slide).
For usability testing, ground truth typically involves observing user interactions and identifying errors or difficulties, rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted for the MetaLite DX Digital Pathology Software as described in this document. The studies performed focus on technical performance (pixel comparison, speed, measurement accuracy) and usability of the software as a viewing and management tool, not on its impact on human reader diagnostic accuracy or efficiency with and without AI assistance. The device is purely a viewer/manager and does not incorporate AI for diagnosis.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described are primarily standalone in the sense that they evaluate the software's technical performance attributes (pixel reproduction, speed, measurement accuracy) independent of a pathologist's diagnostic performance. The usability test involved human interaction but assessed the usability of the software interface, not the diagnostic accuracy of the human using it. The device itself is described as "software only" and an "aid to the pathologist," rather than an AI diagnostic algorithm.

7. Type of Ground Truth Used

Pixel-wise comparison: The ground truth appears to be the output of a reference system (PIPS IMS) for the same iSyntax file. This is a technical ground truth based on image fidelity.
Turnaround time: The ground truth is objective measurement of time.
Measurements: The ground truth is objective, known distances on a calibration scale slide.
Usability testing: The ground truth is based on observed user interactions, identification of use errors, and compliance with human factors principles, as guided by FDA guidelines.

There is no mention of clinical ground truth (e.g., expert consensus on pathology diagnoses, or outcomes data) being used for these particular performance tests, as the device is not a diagnostic AI algorithm.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set size. This is consistent with the device being a viewer and manager of digital images, not an AI algorithm that requires a training set for model development.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for this type of device, this information is not applicable and not provided in the document.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

October 28, 2024

JelloX Biotech Inc. Tzu-Han Fan Medical Laboratory Scientist No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County, 302041 Taiwan

Re: K240303

Trade/Device Name: MetaLite DX Digital Pathology Software Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: December 13, 2023 Received: February 2, 2024

Dear Tzu-Han Fan:

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/cdrb/cfdocs/cfpm/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 QS 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 (QS) 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 mediation-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

Enclosure

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Indications for Use

510(k) Number (if known) K240303

Device Name MetaLite DX Digital Pathology Software

Indications for Use (Describe) For In Vitro Diagnostic Use

MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

October 28, 2024 1. Date of Summary:
1. Submitter: JelloX Biotech Inc. Address: No. 66-5, Shengyi 5th Rd., Zhubei City, Hsinchu County, 302041, Taiwan (R.O.C) Phone: +886-3-6583058 ext 204 Contact: Tzu-Han Fan Email fancyhan@jellox.com

MetaLite DX Digital Pathology

1. Identification of the Device: Proprietary/Trade Name:

	Software
Model Number:	MLDXUS
Version:	1.2.1
Regulation Description:	Whole Slide Imaging System
Review Panel:	88 – Pathology
Regulation Number:	21 CFR 864.3700
Product Code:	QKQ
Device Class:	Class II
510(k) Submission Number:	K240303

1. Identification of the Predicate Device:

Predicate Device Name:	Philips IntelliSite PathologySolution (PIPS)
Model Number:	N/A
510(k) Number:	K203845
Manufacturer:	Philips Medical SystemsNederland B.V.
Regulation Number:	21 CFR 864.3700
Product Code:	PSY
Device Class:	Class II

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ട. Intended Use/ Indications for Use of the Device

For In Vitro Diagnostic Use

MetaLite DX Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

6. Device Description

MetaLite DX Digital Pathology Software is operated as follows:

(1) After the Whole Slide Images (WSIs) are successfully, acquired by using PIPS-UFS, the WSIs are stored in the Local file system. A qualified pathologist will upload compatible iSyntax format digital pathology images, and the software will load them to the "Main Viewer" area of the graphical

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interface for the pathologist to view.

(2) Once properly loaded, the pathologist will use the inherent features of the device (including tools that allow for adjusting the position and viewing angle of the image, measuring lengths between two coordinates, and adding annotations to specific regional areas).
(3) 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).

Table 1. Interoperable Components for Use with MetaLite DX Digital Pathology Software

Component	Manufacturer	Model
Scanner	Philips Medical SystemsNederland B.V.	Ultra Fast Scanner (UFS),Version 1.8.4
Display	Barco NV	MDPC-8127

Table 2. Computer Environment/System Requirements

Environment	Component	Minimum Requirements
Client PC
Hardware	Processor	Intel® Core (TM) I7 11th Gen or above
	Memory	16GB or above
	Storage	USB Flash Drive 8GB or above
Software	Operating System	Windows 10 or above

Summary of Performance Testing 7.

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A series of tests were performed to assess the safety and effectiveness of the subject device, MetaLite DX Digital Pathology Software.

The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)" and "Applying Human Factors and Usability Engineering to Medical Devices (2016)".

Test	Result
Pixel-wise comparison	Pixel-wise comparison study was conducted tocompare images reproduced by MetaLite DXDigital Pathology Software and PIPS IMS forthe same iSyntax file generated from UFS 1.8.4to validate identical image reproduction. Testresults showed that the 95th percentile ofpixelwise differences between MetaLite DXDigital Pathology Software and PIPS IMS wasless than 3 CIEDE2000, indicating that theiroutput images are pixel-wise identical.Therefore, it was determined that color imagesreproduced by MetaLite DX Digital PathologySoftware were visually adequate with respectto its intended use.
Turnaround time	The turnaround time of opening, panning andzooming an image is within 5 seconds, whichhas been determined and found to beadequate for the intended use of the subjectdevice.
Measurements	Measurement accuracy has been verified usinga scanned image of the calibration scale slide.MetaLite DX Digital Pathology Software hasbeen found to perform accurate measurementswith respect to its intended use.
Usability testing	The usability test was conducted per FDAguidance "Applying Human Factors andUsability Engineering to Medical Devices"
	(2016)". The test result demonstrated that the
	subject device has been found to be safe and
	effective for the intended users, uses, and use
	environments.

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All test results demonstrate MetaLite DX Digital Pathology Software meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

Substantial Equivalence Determination 8.

MetaLite DX Digital Pathology Software submitted in this 510(k) file is substantially equivalent in intended use, principles of operation, safety and performance to the cleared Philips IntelliSite Pathology Solution (PIPS) (K203845). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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Item	Subject device	Predicate device	Substantialequivalencedetermination
510(k) No.	K240303	K203845
Proprietary Name	MetaLite DX DigitalPathology Software	Philips IntelliSite PathologySolution (PIPS)	N/A
Manufacturer	JelloX Biotech Inc.	Philips Medical SystemsNederland B.V.
Product Code	QKQ	PSY
Classification	Class II	Class II	Same
Intended Use	For In Vitro Diagnostic UseMetaLite DX DigitalPathology Software is asoftware only device intendedfor viewing and managementof digital images of scannedsurgical pathology slidesprepared from formalin-fixedparaffin embedded (FFPE)tissue for the purposes of	The Philips IntelliSitePathology Solution (PIPS) is anautomated digital slide creation,viewing, and managementsystem. The PIPS is intendedfor in vitro diagnostic use as anaid to the pathologist to reviewand interpret digital images ofsurgical pathology slidesprepared from formalin-fixedparaffin embedded (FFPE)	SameBoth software aredesigned to view andmanage the digital imageof scanned surgicalpathology slides preparedfrom formalin-fixedparaffin embedded (FFPE)tissue.
Item	Subject device	Predicate device	Substantialequivalencedetermination
	pathology primary diagnosis.It is an aid to the pathologistto review, interpret andmanage digital images ofpathology slides.	tissue. The PIPS is not intendedfor use with frozen section,cytology, or non-FFPEhematopathology specimens.The PIPS comprises the ImageManagement System (IMS), theUltra Fast Scanner (UFS) andDisplay. The PIPS is forcreation and viewing of digitalimages of scanned glass slidesthat would otherwise beappropriate for manualvisualization by conventionallight microscopy. It is theresponsibility of a qualifiedpathologist to employappropriate procedures andsafeguards to assure the validityof the interpretation of images
	MetaLite DX DigitalPathology Software is notintended for use with frozensection, cytology, or non-FFPE hematopathologyspecimens.It is the responsibility of aqualified pathologist toemploy appropriateprocedures and safeguards toassure the quality of theimages obtained and, wherenecessary, use conventional
Item	Subject device	Predicate device	Substantialequivalencedetermination
	light microscopy reviewwhen making a diagnosticdecision. MetaLite DXDigital Pathology Software isintended for use with PhilipsUltra Fast Scanner and theBarco MDPC-8127 display.	obtained using PIPS.
Specimen Type	Digitized surgical pathologyslides prepared from FFPEtissue	Surgical pathology slidesprepared from FFPE tissue	Same
Image file format	iSyntax	iSyntax	Same
ImageManipulationFunctions	Panning, zooming, colormanipulation function,annotations, and measurements(distance)	Panning, zooming, colormanipulation function,annotations, and measurements(distance & area)	SimilarSame image manipulationfunction where subjectdevice only measuresdistance
Type ofSoftwareApplication	Stand-alone software	Internet browser-basedapplication	DifferentThe difference in softwareapplication does not raise
Item	Subject device	Predicate device	Substantialequivalencedetermination
DeviceComponents	MetaLite DX DigitalPathology Software	Ultra Fast Scanner (UFS),Image Management System(IMS) and Display	DifferentThe subject device cansubstitute the IMS in thepredicate device and thisdoes not raise new safetyand effectiveness questions
Principle ofOperation	After WSI images aresuccessfully acquired by usingPhilips IntelliSite PathologySolution Ultra Fast Scanner(PIPS-UFS), the pathologistperforms further QC and readsWSI images of the slides tomake a diagnosis	After WSI images aresuccessfully acquired by usingPIPS UFS, the WSI images arestored in IMS ApplicationServer & Storage software thatis not provided as part of thePIPS but may be located in acentral server room separatefrom the workstation with theIMS viewing software andDisplay. During review, the	Same
Item	Subject device	Predicate device	Substantial equivalence determination
Image Storage	Images are stored in the local computer	pathologist opens WSI images from IMS Server & Storage, perform further QC and reads WSI images of the slides to make a diagnosisAfter 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	DifferentNetwork connectivity is not needed for subject software to function
Item	Subject device	Predicate device	Substantialequivalencedetermination
		WSI images of the slides tomake a diagnosis

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9. Similarities and Differences

The subject device has similar indications for use/intended use and principle of operation as the predicate device.

There are three differences between the subject device and the predicate device, including the software application, the device component and the image storage.

For the device component, both devices are intended for viewing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The display used with subject product is Barco MDPC-8127, which has been confirmed to be substantially equivalent to the PS27QHDCR used in predicate device.

For the software application, the subject device is a stand-alone software, in contrast to the predicate device which operates as an internet browser-based software. The difference does not raise new safety and effectiveness questions.

Conversely, as the subject device does not require internet connectivity, it decreases the risk of vulnerability through the internet. The maintenance for the subject device includes installation and update is conducted by qualified specialist of JelloX Biotech Inc., this also enhances network security.

For the image storage, subject device would store images in local computer without using network to assess image data, compared to cloud storage, it significantly reduces the risk of data breaches.

The subject device has undergone safety and performance tests, and the results complied with the test requests. The subject device is substantially equivalent to the predicate device in intended use, principles of operation, safety and performance claims.

Conclusion 10.

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that when MetaLite DX Digital Pathology Software is used with the PIPS USF scanner and the Barco MDPC-8127 display, 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.