(246 days)
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
| 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
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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.
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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.
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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.
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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.
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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.
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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).
- Technical Reference Standards:
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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.
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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.
§ 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.