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510(k) Data Aggregation
(77 days)
2MP Monochrome LCD Monitor MS-S200
MS-S200 is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
21.3 inch (54cm) Monochrome LCD Monitor
1600 x1200 (landscape)
High-luminance monochrome LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
It minimizes luminance unevenness by Uniformity Correction Function to achieve the uniformity of luminance on the whole screen.
Quantitative evaluation and visual evaluation are done before the shipment. Quality control along the QC guideline is conducted.
This document, a 510(k) summary for the JVCKENWOOD 2MP Monochrome LCD Monitor MS-S200, does not describe a study involving an AI/CADe device or human readers interpreting medical images. Instead, it is a submission for a medical display monitor, which is a piece of hardware.
Therefore, the information requested in your prompt (acceptance criteria for an AI device, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
The document focuses on demonstrating substantial equivalence of the new monitor (MS-S200) to a predicate device (MS25i2) based on technical specifications and performance characteristics, not on clinical performance for diagnosis.
To answer your prompt based on the provided text, I can only extract information related to the monitor's performance criteria, not those of an AI diagnostic tool.
Here's what can be extracted from the document regarding the monitor's performance and validation:
1. A table of acceptance criteria and the reported device performance:
The document states: "All items in monitor specification have met the acceptance criteria according to the standard, AAPM-TG18 and ISO 13406-2." It then lists several specifications where the new monitor actually improves upon the predicate device.
| Specification | Predicate Device (MS25i2) Performance | Proposed Device (MS-S200) Performance | Acceptance Criteria (Implicit: Meets or Exceeds Predicate, and complies with AAPM-TG18 and ISO 13406-2) |
|---|---|---|---|
| Response Time (typical) | 40 ms typ. (T on + T off 10%-90%) | 19 ms typ. (T on + T off 10%-90%) | Superior to predicate and conforms to standards. |
| Contrast Ratio | 1400:1 | 1800:1 | Superior to predicate and conforms to standards. |
| Viewing Angle (CR>10:1) | Horizontal: Typ.176, Vertical: Typ.176 | Horizontal: Typ.178, Vertical: Typ.178 | Superior to predicate and conforms to standards. |
| Max Luminance | 1900 cd/m² typ. | 1900 cd/m² typ. | Meets predicate and conforms to standards. |
| DICOM Calibrated Luminance | 0.8 - 410 cd/m² | 0.8 - 410 cd/m² | Meets predicate and conforms to standards. |
| Resolution or Matrix Size | 1200 x 1600 (Portrait) | 1200 x 1600 (Portrait) | Meets predicate and conforms to standards. |
| Grayscale Tones | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | Meets predicate and conforms to standards. |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), ICES-003 (Class B), MDD/CE, VCCI-B (Class B) | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC (Class B), ICES-003 (Class B), MDR/CE, RCM, VCCI-B (Class B) | Covers existing and adds RCM. Conforms to specified safety standards. |
Regarding the other points, they are not applicable because this is a hardware device (monitor), not an AI diagnostic algorithm:
- Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on monitor characteristics, not a clinical data test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for a monitor. Its performance is measured by objective technical standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not AI and does not involve human readers in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. No AI model is being trained.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a medical display monitor, not an AI diagnostic device. The "study" proving it meets acceptance criteria refers to technical verification against industry standards (AAPM-TG18, ISO 13406-2) and comparison to a predicate device's hardware specifications, not a clinical trial or AI performance evaluation.
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