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510(k) Data Aggregation
(35 days)
21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)
21.3 inch (54 cm) Monochrome 2M pixel LCD Monitor MS25i2 (ML21025) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
MS25I2 (ML21025) is a 21.3-inch (54 cm) Monochrome LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.
The provided document is a 510(k) summary for the TOTOKU 21.3 inch (54 cm) Monochrome LCD Monitor MS25I2 (ML21025). This document describes the device and its substantial equivalence to a predicate device, rather than a study proving the device's performance against specific clinical acceptance criteria in the context of an AI/algorithm-based diagnostic product.
Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, how ground truth for training set was established) are not applicable to this document as it pertains to a display monitor, not a diagnostic algorithm.
However, I can extract information related to the technical specifications and verification performed for the display monitor itself.
Acceptance Criteria and Device Performance (Technical Specifications)
The document lists technical specifications (which can be considered acceptance criteria for a display monitor) and implies that the device meets them, primarily through comparison to the predicate device and internal testing.
| Acceptance Criteria (Technical Specification) | Reported Device Performance / Compliance |
|---|---|
| 1. Luminance uniformity | Less than 30% based on AAPM-TG18 4.4. (Refer to actual Luminance uniformity data - data not provided in this extract) |
| 2. Pixel Defects / Fault | Class II or more. ISO13406-2. |
| 3. Artifacts (phase/clock issues, flicker, ringing, ghosting, image sticking) | By visible check, no flicker, ringing, ghosting and image sticking. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | Data not provided in this extract |
| 5. Chromaticity (Delta (u', v')) | Delta (u', v') $(u', v') ≤ 0.01$ measured at 80% Lmax based on AAPM-TG18 4.8.4. (Refer to Chromaticity actual data - data not provided in this extract) |
| Maximum Luminance | 1900 cd/m² (higher than predicate 1800 cd/m²) |
| Contrast Ratio | 1400:1 (higher than predicate 700:1) |
| Grayscale | 10.3 bit (1276 gradation) |
| Safety Standard compliance | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) |
| DICOM calibrated luminance values | 410 cd/m² (same as predicate) |
| Display images in accordance with DICOM GSDF | Yes, by default utilizing factory calibrated display mode. |
| Support Digital Visual Interface (DVI) and DisplayPort | Yes. |
| Front Sensor for luminance stabilization | Yes, enables automatic grayscale calibration. Accuracy data included in "Verification & Validation" section (not provided in extract). |
| Ambient Light Sensor | Yes. |
Study Information (Device Verification and Validation Summary)
The document states:
- "The overall design of the MS25i2 (ML21025) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers."
- "Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the MS25i2 (ML21025) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance."
- Regarding the Front Sensor, "The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 'Verification & Validation' in 'Application'."
However, the specific "Verification & Validation" section with detailed study methodologies, sample sizes, and detailed data is not provided in the supplied text. The evidence for meeting the acceptance criteria is generally stated as:
- Comparison to predicate device: The new device (MS25I2) is considered substantially equivalent to the predicate device (MS23I2) because it shares identical characteristics in display size, active area, input signals, maximum display resolution, pixel pitch, scanning frequency, maximum image clock, luminance calibration software/sensor, serial communication, and grayscale. Key differences like maximum luminance and contrast ratio are improved, and the LED backlight (a new feature) is deemed to have no adverse effects on image quality.
- Compliance with international standards: Safety and EMC standards validation by third-party certifiers.
- Internal system and performance tests: JVC KENWOOD Corporation conducted these tests, with the conclusion that "None of the tests revealed behaviors inconsistent with the expected performance."
Not Applicable (N/A) for AI/Algorithm-specific questions:
- Sample sized used for the test set and the data provenance: N/A (this is a display monitor, not an AI algorithm evaluated on a medical image dataset).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A.
- Adjudication method for the test set: N/A.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for a display monitor is adherence to technical specifications and display standards (e.g., DICOM GSDF).
- The sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
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