(60 days)
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 RX370 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing high contrast ratio and the matrix size (or resolution) is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 RX370 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 RX370.
The provided text describes a 510(k) submission for the EIZO RadiForce RX370, a medical display monitor. The document confirms that the device is substantially equivalent to a predicate device and outlines performance testing conducted. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria.
Here's a breakdown of what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance:
The document mentions that the RadiForce RX370 meets "pre-defined criteria when criteria are set" for its display characteristics, and that it has "display characteristics equivalent to those of the predicate device, RadiForce RX360." It lists several performance tests conducted, but it does not provide a table with specific numerical acceptance criteria and the corresponding reported device performance values.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "No animal or clinical testing was performed on the RadiForce RX370." Therefore, there is no "test set" in the context of patient data or clinical images, and thus no sample size or data provenance to report in that sense. The tests mentioned were "bench tests" performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical or animal testing was performed, there was no "test set" requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical or animal testing with a test set was performed.
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:
Not applicable. The device is a display monitor, not an AI-powered diagnostic tool. No MRMC study was mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given that the performance testing involved "bench tests" on the display monitor itself, the "ground truth" would be the technical specifications and standards (e.g., DICOM GSDF, TG18 guidelines) against which the monitor's performance (luminance, MTF, pixel defects, etc.) was measured.
8. The sample size for the training set:
Not applicable. The device is a display monitor, not an AI system that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of available information regarding acceptance criteria and study:
The device is a medical display monitor (RadiForce RX370) intended for displaying radiological images.
Acceptance Criteria and Reported Device Performance (Partial based on available info):
| Acceptance Criteria Category | Criteria (as implied) | Reported Device Performance (as implied) | Study Type |
|---|---|---|---|
| Spatial Resolution (MTF) | Conformance to specifications | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Pixel Defects/Faults | Maximum number allowed | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Miscellaneous Artifacts | Absence of artifacts (TG18) | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Temporal Response | Conformance to specifications | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Luminance | Conformance to specifications | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| DICOM GSDF Conformance | Conformance to TG18 guideline | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Pixel Aperture Ratio | Conformance to specifications | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
| Color Tracking | Conformance to specifications | Met pre-defined criteria; equivalent to predicate device. | Bench Test |
Study Information:
- Study Name: Performance Testing (Bench Tests)
- Device Under Test: RadiForce RX370
- Sample Size (Test Set): Not applicable (no clinical or animal testing). The "sample" would be the individual monitor unit(s) subjected to the bench tests.
- Data Provenance: Not applicable (no patient/clinical data).
- Ground Truth Establishment (for Test Set): Technical specifications and guidelines outlined in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and AAPM Task Group 18 (TG18 guideline).
- Number of Experts/Qualifications: Not explicitly stated, but the tests are based on established industry guidelines that would have been developed by experts in the field.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance Study: Not applicable (device is a monitor, not an algorithm).
- Training Set Sample Size: Not applicable.
- Training Set Ground Truth: Not applicable.
In essence, the "study" proving the device meets acceptance criteria was a series of engineering/technical bench tests designed to ensure the display characteristics of the RadiForce RX370 met established standards for medical monitors and were equivalent to its predicate device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).