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510(k) Data Aggregation
(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.
Here's an analysis based on the provided text:
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.
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(288 days)
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 the JVC Kenwood JD-C240BN01A display. 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 diagnostic-quality 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, annotated, 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, the NZViewMD Software and the JVC Kenwood JD-C240BN01A display.
Here's a summary of the acceptance criteria and study details for the NanoZoomer S360MD Slide scanner system, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Diagnosis Study) | Reported Device Performance (Primary Diagnosis Study) |
|---|---|
| Upper bound of the two-sided 95% CI of the difference between overall major discordance rates of WSI diagnoses and Glass diagnoses < 4% | Results "very similar to prior studies of digital pathology devices" (0.4% difference for NanoZoomer System compared to glass) |
| Major discordance rate of the WSI diagnoses < 7% | 3.5% major discordance rate for the NanoZoomer System (implied overall, as specific overall rate not explicitly stated, but organ-specific rates are provided and generally fall below this, with some exceptions that are explained by low sample sizes for those specific organs) |
| Acceptance Criteria (Feature Detection Study) | Reported Device Performance (Feature Detection Study) |
|---|---|
| Lower limit of the 95% confidence interval (CI) of the Average Positive Agreement exceeding 85% | Intra-scanner: 94.3% (92.8, 95.7), 95.0% (93.5, 96.3), 94.3% (92.8, 95.7) for individual scanners; Total 94.5% (93.7, 95.3). All CIs exceed 85%. |
| Inter-scanner: 92.5% (90.4, 94.2), 93.1% (91.2, 94.9), 91.4% (89.3, 93.4) for different comparisons; Total 92.4% (90.7, 93.8). All CIs exceed 85%. | |
| Inter-site: 93.1% (90.9, 94.9), 93.6% (91.5, 95.4), 93.7% (91.6, 95.5) for different comparisons; Total 93.4% (91.8, 94.9). All CIs exceed 85%. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the total sample size for the test set across all studies, nor the country of origin. It indicates that the primary diagnosis study involved multiple organs with varying numbers of cases:
- Breast: 1198 (Observed) cases for WSI Major Discordance, 1200 (Observed) for Glass Major Discordance
- Prostate: 1200 (Observed) cases for WSI Major Discordance, 1200 (Observed) for Glass Major Discordance
- Respiratory: 400 cases
- Colorectal: 600 cases
- GE Junction: 400 cases
- Stomach: 400 cases
- Skin: 700 cases
- Lymph Node: 400 cases
- Bladder: 400 cases
- Gynecological: 600 cases
- Liver/Bile Duct: 200 cases each
- Endocrine: 400 cases
- Brain/Neuro: 240 cases
- Kidney: 200 cases
- Salivary Gland: 200 cases
- Hernial/Peritoneal, Gallbladder, Appendix, Soft Tissue Tumors, Anus/Perianal, Other Miscellaneous: Smaller numbers, some as low as 40 or 79.
The data provenance is not specified as retrospective or prospective, but the description of the "Primary Diagnosis Study" suggests a prospective comparison between WSI and glass slide diagnoses.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the exact number of experts (pathologists) involved in establishing the ground truth, nor their specific qualifications (e.g., years of experience). It only states that the system is intended "as an aid to the pathologist to review and interpret digital images" and that "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."
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "major discordance rates" between WSI diagnoses and Glass diagnoses, implying a comparison against an existing diagnosis, but the process of resolving disagreements or establishing a definitive ground truth in cases of discordance is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The study described is a comparative effectiveness study comparing WSI diagnoses to glass slide diagnoses. It is not an "AI vs. without AI assistance" study. The NanoZoomer System is described as an "automated digital slide creation, viewing, and management system" and not specifically an AI-driven diagnostic aid. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable or provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. The NanoZoomer System is described as a tool for a pathologist to review and interpret images – a human-in-the-loop system.
7. The Type of Ground Truth Used
For the primary diagnosis study, the ground truth appears to be established through the comparison of diagnoses made using the NanoZoomer System (WSI diagnoses) versus diagnoses made using conventional light microscopy of glass slides (Glass diagnoses). The document specifically details "major discordance rates" between these two methods rather than against an independent gold standard like pathology or outcomes data. For the feature detection study, the ground truth is inferred by the agreement rates of feature detection across different scans/scanners/sites, essentially defining agreement as the ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. The NanoZoomer System is primarily a slide scanning, viewing, and management system, not described as an AI algorithm that requires a separate training set for diagnostic purposes.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned for an AI algorithm, this information is not applicable.
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