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For In Vitro Diagnostic Use

Viewer+ 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. Viewer+ 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. Viewer+ is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner and BARCO MDPC-8127 display.

Viewer+, version 1.0.1, is a web-based software device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from Hamamatsu NanoZoomer S360MD Slide scanner and viewed on BARCO MDPC-8127 display. Viewer+ renders these digitized pathology images for review, management, and navigation for pathology primary diagnosis.

Viewer+ is operated as follows:

• 1. Image acquisition is performed using the NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary.
• 2. Once image acquisition is complete and the image becomes available in the scanner's database file system, a separate medical image communications software (not part of the device) automatically uploads the image and its corresponding metadata to persistent cloud storage. Image and data integrity checks are performed during the upload to ensure data accuracy.
• 3. The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and areas, and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size of images or cases used for the "Test Set" in the performance studies. It mentions "scanned images of the biological slides" for measurement accuracy and "images reproduced by Viewer+ and NZViewMD for the same file" for pixel-wise comparison.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. It mentions that the device is "an aid to the pathologist" and that "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." However, this relates to the intended use and not a specific part of the performance testing described.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set results. The pixel-wise comparison relies on quantitative color differences, and usability is assessed according to FDA guidance.

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

No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is mentioned or implied in the provided text. The device is a "viewer" and not an AI-assisted diagnostic tool that would typically involve such a study.

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

The performance tests described (pixel-wise comparison, turnaround time, measurements) primarily relate to the technical functionality of the Viewer+ software itself, which is a viewing and management tool. These tests can be interpreted as standalone assessments of the software's performance in rendering images and providing basic functions like measurements. However, it's crucial to note that Viewer+ is an "aid to the pathologist" and not intended to provide automated diagnoses without human intervention. The "standalone" performance here refers to its core functionalities as a viewer, not as an autonomous diagnostic algorithm.

7. Type of Ground Truth Used

• Pixel-wise comparison: The ground truth for this test was the image reproduced by the predicate device's software (NZViewMD) for the same scanned file. The comparison was quantitative (CIEDE2000).
• Measurements: The ground truth would likely be established by known physical dimensions on the biological slides, verified by other means, or through precise calibration. The document states "Measurement accuracy has been verified using scanned images of the biological slides."
• Usability testing: The ground truth here is the fulfillment of usability requirements and user satisfaction/safety criteria, as assessed against FDA guidance.

8. Sample Size for the Training Set

The document does not mention the existence of a "training set" in the context of the Viewer+ device. This is a software-only device for viewing and managing images, not an AI/ML algorithm that typically requires a training set for model development.

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

As no training set is mentioned for this device, information on how its ground truth was established is not applicable.

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