(129 days)
These products are indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
The C1216W and C12*** are 12MP color LCD monitors, which are specifically designed to provide the high definition image output for general radiography. They are using the latest generation of LED back light panel, with high resolution 4200 x 2800, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be quaranteed throughout its life. The anti-qlare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
The provided document describes a 510(k) premarket notification for a medical display monitor, the "12MP Color LCD Monitor (C1216W, C12***)". The primary purpose of this document is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device, the EIZO Corporation's 12MP Color LCD Monitor, RadiForce RX1270 (K200485).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in a tabular format with corresponding reported device performance. Instead, it details performance testing conducted to demonstrate equivalence to the predicate device. The performance characteristics of the proposed device are compared to the predicate device in several tables (Table 1 Intended Use Comparison, and Table 2 General Comparison, which is spread across pages 7 and 8 but not fully reproduced here with all details).
However, based on the "Performance Testing" section (page 9-10), the implied "acceptance criterion" for each test is that the device should demonstrate characteristics equivalent to those of the predicate device or that any differences do not affect observer performance.
Here's a summary of the performance testing performed, which serves as the basis for demonstrating equivalence:
| Acceptance Criteria (Implied from Performance Testing) | Reported Device Performance |
|---|---|
| Conformance to DICOM GSDF (according to AAPM TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device, RadiForce RX1270 except some items, each of which was determined that it would not affect observer's performance." (This general statement applies to all listed performance tests, suggesting compliance for DICOM GSDF.) |
| Luminance non-uniformity characteristics (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Luminance stability and chromaticity response with temperature (0°C, 25°C, 40°C) (according to AAPM-TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Chromaticity non-uniformity characteristics (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Luminance at angles of 30º and 45º (diagonal, horizontal, vertical; center and corners) (by AAPM-TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Temporal response (using typical data from panel manufacturer) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Measurement of Luminance | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." (Specific maximum luminance and DICOM calibrated luminance values are provided in Table 2, page 7, showing slight differences from the predicate which are presumably deemed acceptable as per the general statement.) |
| Visual check for presence/absence of miscellaneous artifacts (according to TG18 guideline) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Spatial noise measurement (by noise power spectrum) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Reflection coefficient measurement (specular and diffuse reflection) (by TG18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Veiling glare measurement (small-spot contrast, by TG-18) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Spatial resolution (expressed as modulation transfer function (MTF)) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Maximum number allowed for each type of pixel defects/faults | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Color tracking and Gray tracking measurement | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
| Pixel fill factor measurement (pixel structure and aperture ratio, etc.) | "The test results showed that C1216W and C12*** are with display characteristics equivalent to those of the predicate device..." |
2. Sample size used for the test set and the data provenance
The document describes bench tests that were performed on the device. It does not mention a "test set" consisting of patient data or clinical images. The testing is based on the device itself and its intrinsic technical characteristics. Therefore, there's no information about sample size for a test set in the conventional sense of a clinical or image-based study, nor about data provenance (country of origin, retrospective/prospective). The tests were conducted on the physical devices C1216W and C12***.
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 as the study described is a bench test of a display monitor, not an interpretative study requiring expert ground truth for medical images.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
An MRMC comparative effectiveness study was not done. This submission is for a medical display monitor and does not involve AI assistance or human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a display monitor, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The "ground truth" in this context refers to established technical standards and measurement specifications, specifically the AAPM Task Group 18 (TG18 guideline), which outlines procedures for evaluating display performance for medical imaging systems. These standards serve as the reference for evaluating the display's inherent technical characteristics.
8. The sample size for the training set
This information is not applicable as the device is a display monitor and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).