(88 days)
The NanoZoomer S360MD Slide scanner system ("NanoZoomer System") is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded ("FFPE") tissue. The NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)-cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. 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 NanoZoomer System.
The NanoZoomer S360MD Slide scanner system is an automated system for creating, viewing, and managing digital slides. The NanoZoomer S360MD Slide scanner system creates diagnosticquality digital images of glass slides containing formalin-fixed paraffin-embedded ("FFPE") tissue. Each digital image covers an entire slide and typically contains billions of image pixels. Slide images may be viewed, stored, retrieved, duplicated, and/or shared, permitting the pathologist to make a primary diagnosis without needing to view the original glass slides through a light microscope.
The NanoZoomer S360MD Slide scanner system is comprised of the NanoZoomer S360MD Slide scanner, NZViewMD image viewing software and compatible display.
The document describes the NanoZoomer S360MD Slide scanner system (K233027), which is an automated digital slide creation, viewing, and management system. This submission primarily focuses on adding compatibility with the BARCO MDPC-8127 Display to the existing NanoZoomer S360MD Slide scanner system (K213883) and establishing a Predetermined Change Control Plan (PCCP) for qualifying additional FDA-cleared displays. No new clinical studies were conducted as part of this submission, as substantial equivalence was demonstrated through non-clinical testing.
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1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the special controls described under 21 C.F.R. § 864.3700 for Whole Slide Imaging Systems, and color reproducibility testing. The reported device performance indicates that the system met these criteria.
| Acceptance Criterion (Test Parameter) | Reported Device Performance (Compliance) |
|---|---|
| 1. Spatial resolution | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 2. Pixel defects (count and map) | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 3. Artifacts | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 4. Maximum and minimum luminance | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 5. Luminance uniformity and Mura test | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 6. Grayscale | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 7. Stability of luminance and chromaticity | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 8. Bidirectional reflection distribution function | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 9. Grav tracking | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 10. Color difference (the display only) | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 11. Color gamut volume | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| 12. Temporal response | Testing was performed to determine compatibility with the BARCO MDPC-8127 Display. (Implies criterion met for substantial equivalence) |
| Color Reproducibility (accuracy and precision) | Test data provided and demonstrated that the product met the acceptance criteria for color accuracy, evaluated using the △E2000 CIEDE2000 metric. |
| Software verification (for BARCO MDPC-8127 display software) | Performed to confirm that the additional software (QA-WEB) did not introduce any issues with the performance of the NanoZoomer S360MD software. (Implies criterion met for substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document specifies that color reproducibility testing "used three NanoZoomer Systems with BARCO MDPC-8127 displays and was conducted using a color calibration slide and a chroma meter." For the other non-clinical tests (spatial resolution, pixel defects, etc.), the document states "compatibility... was determined based on testing the below specified parameters," but it does not explicitly state the number of displays or specific test slides used for each parameter.
- Data Provenance: Not explicitly stated, but the submission is from Hamamatsu Photonics K.K. (Japan), implying the testing was likely conducted by the manufacturer. The tests are non-clinical, so "retrospective or prospective" is not directly applicable in the typical clinical study sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests conducted were non-clinical, related to display and system compatibility parameters. Ground truth for these tests would be established through objective measurement against technical standards and specifications (e.g., using a color calibration slide and chroma meter for color reproducibility), rather than expert assessment of pathological slides.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests were non-clinical technical evaluations and would not involve expert adjudication as typically understood in diagnostic accuracy studies.
5. 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 MRMC study was done. The document explicitly states: "No clinical studies were required to demonstrate substantial equivalence of the modified NanoZoomer S360MD Slide scanner system." This submission focuses on adding a compatible display to an already cleared device and establishing a PCCP, not on evaluating AI assistance or human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The NanoZoomer S360MD Slide scanner system is a whole slide imaging system intended as an aid to a pathologist, not a standalone AI algorithm for diagnosis. The non-clinical tests evaluated the system's technical performance with a new display component.
7. The Type of Ground Truth Used
For the color reproducibility testing, the ground truth was based on a color calibration slide and objective measurements obtained using a chroma meter. For the other non-clinical tests, the ground truth would be against general engineering and display performance specifications and standards relevant to 21 C.F.R. § 864.3700.
8. The Sample Size for the Training Set
Not applicable. This submission concerns compatibility of a new display with an existing cleared system and a PCCP. There is no mention of a machine learning algorithm being trained as part of this submission. The system is a slide scanner and viewer, not an AI diagnostic tool that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI algorithm in this submission.
§ 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.