(226 days)
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:
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- 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.
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- 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.
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- 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
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Pixel-wise comparison (of images reproduced by Viewer+ and NZViewMD for the same file generated from NanoZoomer S360md Slide Scanner) | The 95th percentile of pixel-wise differences between Viewer+ and NZViewMD was less than 3 CIEDE2000, indicating their output images are pixel-wise identical and visually adequate. |
| Turnaround time (for opening, panning, and zooming an image) | Found to be adequate for the intended use of the device. |
| Measurement accuracy (using scanned images of biological slides) | Viewer+ was found to perform accurate measurements with respect to its intended use. |
| Usability testing | Demonstrated that the subject device is 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 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.
§ 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.