Search Results

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 MX216 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 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX216 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce MX216.

The provided text is a 510(k) premarket notification for a medical display device, the RadiForce MX216. The acceptance criteria and performance testing described primarily relate to the display's technical specifications and conformance to industry standards for display devices, not the performance of an AI algorithm or diagnostic tool.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves the device meets the acceptance criteria related to AI/algorithm performance (e.g., sample size for AI test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document. This document describes the substantial equivalence of a medical display monitor to a predicate device based on its physical and performance characteristics as a display.

Here's a breakdown of the information that is available in the document, and what is N/A:

1. A table of acceptance criteria and the reported device performance

The document states that "the display characteristics of the RadiForce MX216 meet the pre-defined criteria when criteria are set." However, a specific table of these pre-defined criteria with corresponding performance test results is not explicitly provided in this document. The criteria are referred to implicitly through the types of bench tests performed.

• Acceptance Criteria (Implicit from tests performed and standards cited):
  • Spatial resolution (MTF)
  • Maximum allowed pixel defects/faults
  • Absence of miscellaneous artifacts (as per TG18 guideline)
  • Temporal response
  • Luminance
  • Conformance to DICOM GSDF (as per TG18 guideline)
  • Color tracking
  • Display characteristics equivalent to the predicate device (RadiForce MX215)
• Reported Device Performance:
  • "The test results showed that the RadiForce MX216 has display characteristics equivalent to those of the predicate device, RadiForce MX215."
  • "Besides, the display characteristics of the RadiForce MX216 meet the pre-defined criteria when criteria are set."

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

• Sample Size: Not applicable in the context of an AI/human reader study. The "test set" here would refer to the RadiForce MX216 units subjected to bench testing. The document does not specify the number of units tested.
• Data Provenance: Not applicable in the context of clinical data for an AI study. The tests are bench tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• N/A. This device is a display monitor, not an AI or diagnostic algorithm that requires expert-established ground truth from medical images. The "ground truth" for this device's performance are the engineering specifications and compliance with industry standards (e.g., DICOM, AAPM TG18).

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

• N/A. No adjudication method is described as this is not a study involving human readers interpreting images.

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:

• N/A. No MRMC study was conducted as this is a medical display device, not an AI-powered diagnostic tool.

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

• N/A. This device is a display. There is no "algorithm only" performance for a monitor. Its function is to display images for human review.

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

• N/A in the context of medical images. The "ground truth" for evaluating this device's performance are technical standards and specifications (e.g., DICOM GSDF, AAPM TG18 guidelines, manufacturer's specifications for resolution, luminance, pixel defects).

8. The sample size for the training set:

• N/A. This document describes a monitor, not an AI algorithm, so there is no "training set."

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

• N/A. As there is no training set, this question is not applicable.

Ask a specific question about this device