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For In Vitro Diagnostic Use

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.

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.

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

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

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