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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."

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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This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

RadiForce MX317W is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) 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 (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.
RadiCS is application software to be installed in each workstation offering worry-free quality control of diagnostic monitors including the RadiForce MX317W based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce MX317W.
RadiCS is Basic Documentation level and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX317W and it's not a medical imaging software.

The provided text describes the RadiForce MX317W, a color LCD monitor for displaying radiological images. It is a Class II device (Product Code: PGY).

Here's an analysis of the acceptance criteria and the study performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and the device's numerical performance against those targets. Instead, it states that the device's characteristics "meet the pre-defined criteria when criteria are set" and that the test results showed "display characteristics equivalent to those of the predicate device, RadiForce MX315W."

However, it lists the types of performance tests conducted, which implies general acceptance criteria for these characteristics:

2. Sample size used for the test set and the data provenance

The document describes bench testsperformed on the RadiForce MX317W. It does not mention a "test set" in the context of clinical data, images, or patient cases. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable to this type of device and study. The testing was performed on the physical monitor itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The ground truth for the performance of a display device is established through technical measurements using specialized equipment and adherence to industry standards/guidelines (e.g., AAPM TG18), rather than expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there was no clinical test set involving human interpretation of images. The performance was assessed through objective physical measurements.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic software, not for a display device like the RadiForce MX317W. The document explicitly states: "No animal or clinical testing was performed on the RadiForce MX317W."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The RadiForce MX317W is a display device, not an algorithm or AI system. Its performance is assessed as a standalone hardware unit for displaying images, not as an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the display characteristics (e.g., MTF, luminance, DICOM GSDF conformance) was established based on technical standards and guidelines, specifically "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28, 2022, and the "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)". This involves objective physical measurements against defined technical specifications.

8. The sample size for the training set

This information is not applicable. The RadiForce MX317W is a hardware display device and does not involve machine learning algorithms that require a "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there was no training set.

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