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510(k) Data Aggregation
(21 days)
The D-VIEW 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E) LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
LCD display is a display system for medical viewing, with high resolution 1600 x 1200(X213C2P0E , X213G2P0E) and 2048 x 1536 (X213C3P0E , X213G3P0E), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. These displays can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display from damage under hard using conditions, make the clean and disinfect easier.
The provided text describes a 510(k) premarket notification for a medical LCD display, comparing it to a predicate device to demonstrate substantial equivalence. The document does not describe a study that proves the device meets clinical acceptance criteria in the manner requested.
Specifically, the document focuses on technical specifications, regulatory compliance (IEC standards, 21 CFR 1020.33), and a comparison of physical and performance characteristics with a predicate device. It asserts "substantial equivalence" based on these factors, rather than providing clinical performance data or studies against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and details about training sets, are not present in this document. The device in question is a display, not an AI algorithm or a diagnostic tool that provides an output requiring such validation.
However, I can extract the information related to the acceptance criteria as described in this document, which are primarily technical standards and substantial equivalence to a predicate device.
Acceptance Criteria and Study for D-VIEW LCD Display (K151854)
The "acceptance criteria" for this device, as presented in this 510(k) submission, are primarily based on demonstrating substantial equivalence to a predicate device (BARCO N.V., Coronis 3MP, K131246) and compliance with relevant technical and safety standards. There is no clinical study that "proves the device meets acceptance criteria" in the sense of diagnostic accuracy or clinical outcomes presented here, as the device is a display monitor. The demonstration of equivalence and compliance serves as the proof of meeting regulatory acceptance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence and Compliance) | Reported Device Performance (Proposed Device: D-VIEW 3MP/2MP LCD display) | Basis for "Acceptance" (as per the document) |
|---|---|---|
| Intended Use: Functionally identical to predicate. | "The D-VIEW 3MP and 2MP LCD Display is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners." | "Review of ID 1 - Intended use, both of them are intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. So the SE is not affected." |
| Technical Characteristics: Comparable to predicate, and compliant with relevant standards (21CFR1020.33). | Panel Size and Type: 21.3", TFT LCD display (same as predicate). | |
| Pixel Pitch: 0.2115 × 0.0705mm (3MP), 0.270 × 0.270mm (2MP) (comparable to predicate's 0.2115 mm). | ||
| Native Resolutions: 1600 x 1200 (2MP), 2048 x 1536 (3MP) (comparable to predicate's 2048 x 1536). | ||
| Brightness: Varies by model (e.g., 1900cd/m2 for 2MP X213G2P0E, 800cd/m2 for 3MP X213C3P0E), generally comparable or exceeding predicate's 1700 cd/m2. | ||
| Contrast Ratio: 1400:1 (predicate: 1300:1). | ||
| Operating Temperature: 0°C ~ 40°C (same as predicate). | ||
| Storage Temperature: -20°C ~ 60°C (same as predicate). | ||
| Operating Humidity: 30% ~75%(non-condensing) (comparable to predicate's 8% ~80%). | "All of parameters comply with 21CFR1020.33 and related IEC standards. We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE)." | |
| "Contrast Ratio... 1400:1 is better than 1300:1 in terms of the image quality. Therefore, they can be considered Substantially Equivalent in safety and effectiveness." | ||
| Safety and EMC Standards Compliance: Adherence to IEC 60601-1, IEC 60601-1-2. | Electrical & Mechanical safety & Thermal safety: Evaluation conducted as per IEC 60601-1. | |
| EMC Evaluation: Complying with IEC 60601-1-2. | "Review of ID 8 - Electrical & Mechanical safety& Thermal safety, both are the same, so the SE is not affected." | |
| "Review of ID 9 - EMC, both are the same, so the SE is not affected." | ||
| Biocompatibility: No direct patient contact. | "The proposed device does not contain any components that come into direct or indirect contact with patients, so the evaluation doesn't need to be needed [sic]." | "Review of ID 6 - Biocompatibility, both are the same, so the SE is not affected." |
| Sterility: No sterilization required. | "The proposed device does not need sterilization." | "Review of ID 7 - Sterility, both are the same, so the SE is not affected." |
Detailed breakdown of requested information based on the document's content:
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document does not describe a clinical test set or data provenance for evaluative performance. The "study" here is primarily a technical comparison and compliance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device (a display monitor) in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set requiring adjudication is described.
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:
- No. This device is an LCD display, not an AI-assisted diagnostic tool. An MRMC study is not relevant to its type or to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / No. This is a hardware display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. As mentioned, ground truth for diagnostic purposes is not relevant for this submission about a display monitor. The "ground truth" equivalent would be established technical standards and the specifications of the predicate device.
8. The sample size for the training set:
- Not applicable / Not provided. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set or ground truth in that context is described.
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