(35 days)
21.3 inch (54 cm) inch Monochrome Digital Mammography 3M pixel driving techniques enabling 9M sub-pixels to be driven independently. MS352 (ML21035) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PAC'S and modalities including FFDM.
MS35i2 (ML21035) is a 21.3 inch (54 cm) monochrome LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and DisplayPort.
The provided text is a 510(k) summary for a medical display device, the TOTOKU 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS35i2 (ML21035). It does not describe an AI/ML-driven device or an algorithm that requires a study to prove it meets acceptance criteria in the context of diagnostic accuracy, comparative effectiveness with human readers, or standalone algorithm performance.
This document describes a display monitor and its features, comparing it to an earlier predicate device (MS33i2, K112145) to demonstrate substantial equivalence for regulatory approval. The "study" referenced in the prompt (proving the device meets acceptance criteria) in this context refers to the validation and testing of the monitor's technical specifications and performance characteristics to ensure it is safe and effective for its intended use, particularly for displaying mammography images.
Therefore, many of the requested points related to AI/ML device studies (like sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable to this type of medical device submission.
However, I can extract and present the acceptance criteria and reported performance for the display monitor itself, based on the information provided, and explain why other points are not relevant.
Acceptance Criteria and Reported Device Performance (TOTOKU MS35i2 Display)
This device is a medical display monitor, not an AI/ML diagnostic algorithm. The "acceptance criteria" and "study" proving performance primarily revolve around the display's technical specifications and adherence to relevant standards for medical image display.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a display monitor are typically based on its physical and optical performance characteristics relevant to medical imaging, often benchmarked against standards like DICOM GSDF and AAPM-TG18. The document establishes substantial equivalence by comparing the proposed device (MS35i2) to a predicate device (MS33i2) and highlighting key performance metrics.
| Acceptance Criteria / Performance Metric | Predicate Device (MS33i2, ML21033) | Proposed Device (MS35i2, ML21035) | Meets Criteria? (Comparison to Predicate) |
|---|---|---|---|
| Intended Use | Displaying medical images for diagnosis in digital mammography PACS and modalities. | Displaying medical images for diagnosis in digital mammography PACS and modalities, including FFDM. | Equivalent. Specific mention of FFDM for proposed device reinforces its suitability for mammography. |
| Display Area (H x V) | 318.0mm x 423.9mm (Landscape) / 423.9mm x 318.0mm (Portrait) | 324.864mm x 433.152mm (Landscape) / 433.152mm x 324.864mm (Portrait) | Proposed device has a larger active area, but the maximum display sizes (pixel count) are the same, which is deemed not to affect safety and effectiveness. |
| Maximum Display Resolution (Sub-pixel) | 1536 x 6144 (Portrait), 6144 x 1536 (Landscape) | 1536 x 6144 (Portrait), 6144 x 1536 (Landscape) | Same (Equivalent). This is a key measure of image detail. |
| Pixel Pitch | 0.207mm x 0.207mm | 0.2115mm x 0.2115mm | Slightly larger pixel pitch in the proposed device (due to larger screen size with same pixel count). This is implicitly accepted as not affecting safety/effectiveness given the overall comparison. |
| Input Signal | DVI-D, DisplayPort | DVI-D, DisplayPort | Same (Equivalent). |
| Maximum Luminance | 1000 cd/m² | 1700 cd/m² | Higher in the proposed device. The document states "The DICOM calibrated luminance values of the both devices are the same (500 cd/m2) though the typical maximum luminance value (1700 cd/m2) is higher than that of the predicate device (1000 cd/m2)." This is presented as an improvement due to LED backlight. |
| DICOM Calibrated Luminance | 500 cd/m² (Implied, as it's stated for both as "the same") | 500 cd/m² | Same (Equivalent). Critical for medical image display standardization. |
| Luminance Calibration Software/Sensor | Medivisor Nx, Chroma5 (X-Rite) (Optional Sensor) | Medivisor Nx, Chroma5 (X-Rite) (Optional Sensor) | Same (Equivalent). Ensures consistent and accurate display calibration. |
| Contrast Ratio | 900:1 | 1400:1 | Higher in the proposed device (Improvement). |
| Grayscale | 10.3 bit (1276 gradation) | 10.3 bit (1276 gradation) | Same (Equivalent). Indicates high fidelity in displaying shades of gray crucial for medical images. |
| Compliance with DICOM GSDF | Yes (by default, utilizing factory calibrated mode) | Yes (by default, utilizing factory calibrated mode) | Same (Equivalent). Adherence to this standard is fundamental for medical displays. |
| Safety Standard Compliance | UL60601-1, CSA C22.2 No. 601-1, FCC-B, VCCI-B, MDD/CE | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) | Equivalent (Updated standards referenced, but fundamental safety compliance maintained). The device was "validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." |
| Automatic Grayscale Calibration (Front Sensor) | Yes | Yes | Same (Equivalent). Ensures maintenance of image quality without constant manual intervention. |
Note on "Acceptance Criteria" for a Device: For a display monitor, acceptance criteria are the validated performance specifications that demonstrate it is safe, effective, and suitable for its intended use. The "study" here refers to the engineering tests and validation activities (e.g., luminance response, uniformity, geometrical distortion, veiling glare, noise, chromaticity) performed by the manufacturer to ensure these specifications are met and that the device performs as expected.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of diagnostic image data. The "test set" here refers to the device itself and its components. Performance evaluations were conducted on the manufactured display unit(s).
- Data Provenance: Not applicable. This is not a study involving patient data. The "data" refers to the measured performance characteristics of the monitor hardware.
3. Number of Experts Used and Qualifications for Ground Truth
- Number of Experts: Not applicable. The "ground truth" for a display monitor's performance is established by objective physical measurements using calibration equipment and adherence to industry standards (e.g., DICOM Part 14, AAPM TG-18).
- Qualifications of Experts: Not applicable. The "experts" would be engineers and technicians performing the physical measurements and validations, rather than medical experts establishing diagnostic ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. There is no subjective human interpretation of outputs to be adjudicated. Performance is measured objectively.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of an AI/ML algorithm on human reader performance, not for a standalone hardware device like a display monitor.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a display monitor, not an algorithm. Its performance is inherent in its display capabilities, not in an independent algorithm's output.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is based on objective physical measurements and adherence to established industry-wide technical standards and specifications for medical displays (e.g., luminance, contrast, resolution, grayscale fidelity according to DICOM GSDF, uniformity, and geometrical distortion as per AAPM-TG18 guidelines). It also includes compliance with safety and EMC standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI/ML model or "training set" in the context of this device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: 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).