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510(k) Data Aggregation
(269 days)
RadiForce MX317W-PA
RadiForce MX317W-PA is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software that have been validated for use with this device.
RadiForce MX317W-PA is an aid to the pathologist and is used for review and interpretation of histopathology slides for the purposes of primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using this product. The display is not intended for use with digital images from frozen section, cytology, or non- formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
RadiForce MX317W-PA is a color LCD monitor for viewing digital images of histopathology slides. The color LCD panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size is 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1674 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve, a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
"Patho" is for intended digital pathology use mode.
The provided FDA 510(k) clearance letter for the RadiForce MX317W-PA describes a display device for digital histopathology. It does not contain information about an AI/ML medical device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (such as accuracy, sensitivity, specificity, MRMC studies, and ground truth establishment methods for large datasets) is not present in this document.
The document primarily focuses on the technical performance and equivalence of a display monitor to a predicate device. The "performance testing" section refers to bench tests validating display characteristics like spatial resolution, luminance, and color, not the clinical performance of an AI algorithm interpreting medical images.
Given the information provided, here's an analysis based on the actual content:
Based on the provided document, the RadiForce MX317W-PA is a display monitor, not an AI/ML medical device designed for image interpretation. Therefore, the acceptance criteria and study detailed below pertain to the display's technical performance and its equivalence to a predicate display, not to an AI algorithm's diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "the display characteristics of the RadiForce MX317W-PA meet the pre-defined criteria when criteria are set." However, the exact numerical acceptance criteria for each bench test (e.g., minimum luminance, pixel defect limits) are not explicitly listed in the provided text. The document only lists the types of tests performed and states that the device "has display characteristics equivalent to those of the predicate device" and "meet the pre-defined criteria."
| Acceptance Criteria Category | Reported Device Performance Summary (as per document) |
|---|---|
| User controls (Modes & settings) | Performed, assumed met |
| Spatial resolution | Performed, assumed met, equivalent to predicate |
| Pixel defects | Performed, assumed met, equivalent to predicate |
| Artifacts | Performed, assumed met, equivalent to predicate |
| Temporal response | Performed, assumed met, equivalent to predicate |
| Maximum and minimum luminance | Performed, assumed met, equivalent to predicate |
| Grayscale | Performed, assumed met, equivalent to predicate |
| Luminance uniformity and Mura test | Performed, assumed met, equivalent to predicate |
| Stability of luminance and chromaticity response | Performed, assumed met, equivalent to predicate |
| Bidirectional reflection distribution function | Performed, assumed met, equivalent to predicate |
| Gray Tracking | Performed, assumed met, equivalent to predicate |
| Color scale | Performed, assumed met, equivalent to predicate |
| Color gamut volume | Performed, assumed met, equivalent to predicate |
Note: The document only states that these tests were performed and that the results show equivalence to the predicate device and that the device meets pre-defined criteria. It does not provide the specific numerical results or the exact numerical acceptance criteria for each test.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document describes bench tests performed on a single device, the RadiForce MX317W-PA (it's a physical monitor, not a software algorithm processing a dataset). There is no mention of a "test set" in the context of a dataset of medical images.
- Data Provenance: Not applicable. The "data" here refers to the measured performance characteristics of the physical display device itself during bench testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The ground truth for a display monitor's technical performance is established by standardized measurement equipment and protocols, not by expert interpretation of images. The device itself is the object under test for its physical characteristics.
4. Adjudication Method for the Test Set
- Not applicable. This concept applies to human or AI interpretation of medical images, where discrepancies among readers or algorithms might need resolution. For physical device performance, measurements are generally objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not performed/Applicable. An MRMC study is designed to assess the performance of a diagnostic aid (like AI) on image interpretation by human readers. This device is a display monitor, not an AI algorithm. Its function is to display images, not to interpret them or assist human interpreters in a diagnostic decision-making process that would warrant an MRMC study.
6. Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. As stated, this is a display monitor, not an algorithm.
7. Type of Ground Truth Used:
- The ground truth for the display's performance tests would be metrology-based standards and calibration references (e.g., standard luminance values, colorimetry standards) against which the display's output is measured. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy studies.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware; it does not involve training data or machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set exists for this device.
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