(136 days)
The Scan View System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types: CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
The Scan View System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytogenetics experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
The provided text describes the regulatory submission for the ScanView device but does not contain detailed acceptance criteria or a comprehensive study plan or results that would allow for a complete answer to all parts of the request.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document mentions "bench and clinical data demonstrate that the device meets the required specifications," but the specifications themselves are not provided.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, processing speed) are reported in the text.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned. The "Indications for Use" states the device is an "aiding tool to the pathologist or cytogeneticist," implying these are the expected users, but it doesn't specify their role in establishing ground truth for the study.
4. Adjudication Method:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: Not indicated. The document focuses on the device as an "aiding tool" but doesn't describe a study comparing human performance with and without AI assistance.
- Effect size: Not applicable as no MRMC study details are provided.
6. Standalone Performance Study:
- Was it done?: Not explicitly stated, but the "Safety & Effectiveness" section notes "bench and clinical data demonstrate that the device meets the required specifications." This implies some form of device performance assessment, but whether it was "standalone" in detail (without human in the loop for assessment) is not clear, nor are the results provided.
7. Type of Ground Truth Used:
- Not mentioned.
8. Sample Size for the Training Set:
- Not mentioned.
9. How the Ground Truth for the Training Set Was Established:
- Not mentioned.
Summary of available information:
- Device Name: ScanView
- Intended Use: Automated scanning microscope and image analysis system for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in detecting, classifying, and enumerating cells of interest based on color, intensity, size, pattern, and shape.
- Specific Indication: Detects CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc.) and is limited to the analysis of CEP XY probes for assessing bone marrow transplantation effectiveness in opposite-sex transplants.
- Compliance: Designed, verified, and validated complying with 21CFR 820.30 regulations. Bench and clinical data were used.
- Predicate Devices: FISHView K050236 and CytoVision CEP XY K042542.
Conclusion:
The provided 510(k) summary focuses on the regulatory submission, device description, and indications for use. It makes a general claim of demonstrating safety and effectiveness through "bench and clinical data" but does not provide the specific details of the acceptance criteria, study design, sample sizes, ground truth establishment, or performance results that are requested. To answer these questions, one would need to access the full 510(k) submission document or a more detailed technical report.
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).