(56 days)
Monochrome LCD Monitors (TX-5M, TX-3M, TX-2M) intended to be used in various kinds of medical image application for which the device complies with the performance specified by the manufacturer of the system. These monitors are not intended for use in mammography.
Monochrome LCD Monitors(TX-5M, TX-3M, TX-2M) are used to display images such as Xray, MRI images. These models have resolutions of: 2560x2048, 2048x1536, 1600x1200. These models have USB functions and an optional photo sensor GFU12-SEQ01 made by SEQUEL IMAGING INC. These models are cortified to the EN60601-1 medical safety standard. The monitors use universal Power Supply compatible with AC100V~240V, 50/60Hz. The graphics card needed for the personal computer is the Real Vision & Matrox Scries. The monitors may be deployed in the portrait or the landscape position.
This document describes a 510(k) submission for the "Truepix LCD Medical Display Monitor" (Models: TX-5M, TX-3M, TX-2M). It's important to note that this is a submission for a medical display monitor, not an AI or algorithm-based device. Therefore, many of the typical acceptance criteria and study aspects related to AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) don't apply directly here.
The "acceptance criteria" for a medical display monitor primarily revolve around meeting technical specifications and demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this typically involves technical testing and comparison against the predicate device's specifications.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the technical specifications of the predicate device (Lumimed MM20, MM30, and MM50 Monitors). The "reported device performance" are the specifications of the Truepix monitors, which the manufacturer asserts are substantially equivalent.
| Acceptance Criteria (from Predicate Device: Lumimed MM20, MM30, and MM50) | Reported Device Performance (Truepix TX-2M, TX-3M, TX-5M) |
|---|---|
| Panel Size and Type: 21.3" /20.1" TFT monochrome LCD display | Truepix TX-2M: 21.3" TFT monochrome LCD display |
| Truepix TX-3M: 21.3" TFT monochrome LCD display | |
| Truepix TX-5M: 20.1" TFT monochrome LCD display | |
| Pixel Pitch: 0.270mm x 0.270mm, 0.2115mm x 0.2115mm, 0.156mm x 0.156mm | Truepix TX-2M: 0.270mm x 0.270mm |
| Truepix TX-3M: 0.2115mm x 0.2115mm | |
| Truepix TX-5M: 0.156mm x 0.156mm | |
| Native Resolutions (examples): 1200x1600(portrait), 1536x2048(portrait), 2048x2560 (portrait) | Truepix TX-2M: 1200x1600 (portrait) |
| Truepix TX-3M: 1536x2048 (portrait) | |
| Truepix TX-5M: 2048x2560 (portrait) | |
| Brightness (examples): 1000cd/m², 900cd/m², 850cd/m² | Truepix TX-2M: 1000cd/m² |
| Truepix TX-3M: 800cd/m² | |
| Truepix TX-5M: 850cd/m² | |
| Contrast Ratio (examples): 700:1, 700:1, 600:1 | Truepix TX-2M: 700:1 |
| Truepix TX-3M: 700:1 | |
| Truepix TX-5M: 600:1 | |
| Dot Clock (examples): 125MHz, 130MHz, 162MHz | Truepix TX-2M: 129MHz |
| Truepix TX-3M: 130MHz | |
| Truepix TX-5M: 166.52MHz | |
| Network Interface: USB (1 Up, 2 Downstream) | Truepix TX-2M, TX-3M, TX-5M: USB (1 Up, 4 Downstream) |
| Power: AC 100~240Volts/60Hz, DC 12V, 6.67A | Truepix TX-2M, TX-3M, TX-5M: AC 100~240Volts/60Hz, DC 12V, 6.67A |
| Luminance Calibration: Software (Optional), Photo-sensor (Optional) | Truepix TX-2M, TX-3M, TX-5M: Software (Optional), Photo-sensor (Optional) |
| Safety Certifications: EN60601-1 (Implicit for predicate as well, mentioned for new device) | Truepix TX-2M, TX-3M, TX-5M: Certified to the EN60601-1 medical safety standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a display monitor, performance testing would typically involve evaluating parameters like luminance, contrast, resolution, uniformity, color accuracy (for color displays, though this is monochrome), viewing angle, and stability over time. These tests are conducted on the physical device itself rather than on a "test set" of medical images or patient data. Therefore, concepts like data provenance, retrospective/prospective, and sample size of a test set of data are not applicable in the way they would be for an AI algorithm.
The testing would be on a sample of the manufactured monitors. The document states "Testing was performed according to internal company procedures," but does not detail the sample size (e.g., how many monitors were tested) or the methodology of this internal testing.
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)
This is not applicable as the device is a display monitor, not a diagnostic algorithm that interprets medical images. Therefore, there's no "ground truth" to be established by medical experts for a "test set" of images. The performance metrics are technical specifications of the display hardware.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons 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
This is not applicable. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on reader performance. This document is for a display monitor, which does not incorporate AI or directly assist in diagnostic interpretation beyond presenting the image.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as there is no algorithm being submitted for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable as the device is a display monitor and does not involve diagnostic interpretations requiring such ground truth.
8. The sample size for the training set
This is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
Summary of the Study and Conclusion:
The "study" in this context is a comparison of technical specifications of the new device (Truepix LCD Medical Display Monitors) against a legally marketed predicate device (Lumimed MM20, MM30, and MM50 Monitors). The manufacturer performed "Testing... according to internal company procedures" to ensure the monitors met safety standards (EN60601-1) and performed comparably to the predicate. The conclusion drawn is that "In all material respects, the Truepix LCD Medical Display Monitors are substantially equivalent to the predicate device." This substantial equivalence, based on similar indications for use and comparable technological characteristics and performance specifications, allowed the device to receive 510(k) clearance from the FDA.
§ 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).