(28 days)
RadiForce RX210 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 RX210 is a 54cm (21.3") Color LCD display for medical image viewing. RX210 displays high-definition medical imaging.
This is a 510(k) premarket notification for a medical display, not a medical device that performs diagnostic analysis. Therefore, the traditional acceptance criteria and study design for evaluating diagnostic performance (like those involving sensitivity, specificity, expert readers, etc.) are not applicable here.
The document describes the RadiForce RX210 Color LCD Monitor and establishes its substantial equivalence to a predicate device (RadiForce R22, K033466) based on technological characteristics and intended use.
Here's the information derived from the provided text, adapted to the context of a medical display’s regulatory review:
1. Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence)
For medical displays, acceptance criteria typically revolve around demonstrating that the new device performs at least as well as, or is substantially equivalent to, an already legally marketed predicate device, especially in key performance parameters relevant to image display for diagnosis.
| Acceptance Criteria Category | Specific Criteria (Implicitly from Predicate) | RadiForce RX210 Reported Performance |
|---|---|---|
| Image Resolution | Same as predicate (1600 x 1200) | 1600 x 1200 (same as predicate) |
| Panel Size & Type | 54 cm (21.3") TFT color LCD panel | 54 cm (21.3") TFT color LCD panel (same as predicate) |
| Pixel Pitch | 0.270 x 0.270 mm | 0.270 x 0.270 mm (same as predicate) |
| Display Colors | 16,777,216 colors | 16,777,216 colors (same as predicate) |
| Viewing Angles | H: 170°, V: 170° | H: 170°, V: 170° (same as predicate) |
| Brightness | 250 cd/m² (predicate) | 600 cd/m² (Typical) (improved) |
| Contrast Ratio | 400:1 (typical) (predicate) | 600:1 (typical) (improved) |
| Response Time | 50 ms (typical) (predicate) | 25 ms (typical) (improved) |
| Luminance Calibration | Software (Optional), Photo-sensor (Optional), Protection Panel (Optional) | Software (Optional), Photo-sensor (Optional), Protection Panel (Optional), Digital Uniformity Equalizer (DUE) (improved/added feature) |
| Intended Use | Displaying and viewing digital images for diagnosis of X-ray or MRI etc. by trained medical practitioners (Not for digital mammography systems) | Same as predicate |
Study Proving Acceptance Criteria (Substantial Equivalence Justification):
The "study" in this context is the comparison presented in the 510(k) submission, primarily in the form of a comparison table (Appendix 1 / {1}) and a narrative describing the technological characteristics and intended use. It demonstrates that the new device, RadiForce RX210, is substantially equivalent to the predicate device, RadiForce R22 (K033466).
The key argument is that the RX210 maintains the core functional aspects (like resolution, panel type, pixel pitch) of the predicate device while introducing improvements (higher brightness, contrast, faster response time, and the addition of Digital Uniformity Equalizer (DUE) for luminance non-uniformity compensation). The intended use is identical, and the software for calibration remains unchanged.
Regarding the other requested information (which are generally not applicable to this type of device submission):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This submission is for a display monitor, not an algorithm or diagnostic test evaluated on a dataset of patient images. The "test" is a comparison of technical specifications against a predicate device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth in the sense of diagnostic accuracy for a display monitor itself. The "ground truth" here is the established performance and safety of the predicate device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI-enabled diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware device for display, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, traditional ground truth for diagnostic accuracy is not relevant here. The ground truth for this submission is the regulatory acceptance and safety/effectiveness of the predicate device, against which the new device's technical specifications are compared.
- 8. The sample size for the training set: Not applicable. This is not a machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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).