(18 days)
RadiForce GS320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 displays high-definition medical imaging.
The provided document is a 510(k) summary for a medical display monitor (EIZO NANAO CORPORATION Monochrome LCD Monitor, RadiForce GS320), not a device that utilizes AI or provides diagnostic interpretations. Therefore, many of the requested fields regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of device and are not present in the submission.
The 510(k) process for a monitor like this focuses on demonstrating substantial equivalence to a predicate device through technical specifications and intended use, rather than clinical performance studies that directly assess AI accuracy or human reader improvement.
Here's the information that can be extracted or noted as not applicable based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical display monitors, "acceptance criteria" and "reported device performance" are typically defined by technical specifications and adherence to standards, rather than clinical accuracy metrics. The comparison is primarily against a predicate device's technical specifications.
| Characteristic | Acceptance Criteria (Predicate Device K060845 - RadiForce G310) | Reported Device Performance (RadiForce GS320) |
|---|---|---|
| Panel Size and Type | 53 cm (20.8") TFT Monochrome LCD panel | 54 cm (21.3") TFT Monochrome LCD panel |
| Pixel Pitch | 0.207 x 0.207mm | 0.2115 x 0.2115mm |
| Ratio of Sub-pixel Opening Areas | 4: 4: 4 | Same as predicate |
| Grayscale Tones | 1,024 from a pallet of 8,161 | Same as predicate |
| Viewing Angles | H: 170°, V: 170° | Same as predicate |
| Scanning Frequency (H, V) | 31-100kHz, 48-71.5Hz (VGA Text: 69-71Hz) Frame synchronous mode: 59-61Hz | Same as predicate |
| Native Resolutions | 1536 x 2048 | Same as predicate |
| Brightness | 700 cd/m² (Typical) | Same as predicate |
| Contrast Ratio | 900: 1 (typical) | 850: 1 (typical) |
| DOT Clock | 165 MHz | Same as predicate |
| Response Time | 50 ms (typical) | Same as predicate |
| Active Display Size (H x V) | 318 x 424 mm | 324 x 433 mm |
| Viewable Image Size | 529 mm (20.8") (diagonal) | 541mm (21.3") (diagonal) |
| Luminance Calibration | Built-in swing calibration sensor provided | Same as predicate |
| Input Signals | DVI Standard 1.0 | Same as predicate |
| Input Terminals | DVU-D 24 pin | Same as predicate |
| USB Ports / Standard | 1 upstream, 2 downstream | 1 upstream, 2 downstream/Standard Rev.2.0 |
| Power | AC100-120V, 200-240V, 50/60Hz | Same as predicate |
| Power Management | DVI-DMPM | Same as predicate |
| Dimensions (W x H x D) | With Stand: 368 x 515.5 mm – 597.5 x 209 mm Without Stand: 368 x 486 x 90 mm | With Stand: 376 x 522.5 mm – 604.5x 208.5 mm Without Stand: 376 x 500 x 92 mm |
| Certifications & Standards | TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus (UL2601-1, CSA C22.2 No. 601-1), VCCI-B, FCC-B, Canadian ICES-003-A, CCC | Same as predicate |
The key acceptance criterion here is demonstrating "substantial equivalence" to the predicate device (RadiForce G310, K060845), meaning the new device has similar technological characteristics and intended use, and does not raise new questions of safety or effectiveness. The reported performance of the GS320 is compared directly against the specifications of the GS310. The submission states: "Comparison table of the principal characteristics of 2 devices in Attachment 1 shows that new and predicate devices are substantially equivalent in the areas of technical characteristics, general functions." The modifications noted are a slightly larger panel size and a lower contrast ratio, with the submission implicitly arguing these do not negate substantial equivalence for the intended use.
2. Sample size used for the test set and the data provenance
N/A. This is a medical display monitor, not an AI or diagnostic device that would typically undergo testing with a "test set" of patient data. The evaluation is based on engineering specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. No ground truth or expert evaluation of diagnostic performance is mentioned or required for this type of device submission.
4. Adjudication method for the test set
N/A. No test set for diagnostic performance is mentioned.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a medical display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
N/A. Ground truth is not relevant for a medical display monitor's 510(k) submission, which focuses on technical specifications and substantial equivalence.
8. The sample size for the training set
N/A. This device does not involve a training set as it's a hardware monitor, not a machine learning algorithm.
9. How the ground truth for the training set was established
N/A. Not applicable for a hardware 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).