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510(k) Data Aggregation
(56 days)
The 2MP/3MP LCD Monitor (HMD2C21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) is a display system for medical viewing, with high resolution 1600x1200(HMD2C21)/2048 x 1536(HMD3C21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
This document is a 510(k) summary for the Hisense 2MP/3MP LCD Monitors (HMD2C21/HMD3C21). A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective. This type of submission focuses on comparing the new device's characteristics to a predicate, rather than an independent study to define acceptance criteria and then demonstrate performance against those specific criteria using a test set and ground truth.
Therefore, the requested information cannot be fully provided in the typical format of an AI/ML device study. Instead, I will describe the comparisons made to establish substantial equivalence.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of formal acceptance criteria and device performance as typically seen in a diagnostic AI study, this document compares the technical specifications and intended use of the proposed devices (Hisense HMD2C21 and HMD3C21) against their predicate devices (BARCO Nio 2MP and Nio 3MP). The "acceptance criteria" here is effectively meeting comparable specifications to the predicate device, thereby demonstrating substantial equivalence.
Table 1: Comparison of Proposed Devices (Hisense HMD3C21/HMD2C21) to Predicate Devices (BARCO Nio 3MP/2MP)
| Feature | "Acceptance Criteria" (Predicate Device Performance) (Nio 3MP) | Proposed Device Performance (HMD3C21) | "Acceptance Criteria" (Predicate Device Performance) (Nio 2MP) | Proposed Device Performance (HMD2C21) | Conclusion on Equivalence |
|---|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | Same | Substantially Equivalent |
| Panel Size | 21.3" | 21.2" | 21.3" | 21.3" | Substantially Equivalent (difference deemed non-critical) |
| Pixel Pitch | 0.2115 mm | 0.21075 mm | 0.27 mm | 0.27 mm | Substantially Equivalent (proposed device is slightly better) |
| Brightness (typ.) | 800 cd/m² | 900 cd/m² | 800 cd/m² | 770 cd/m² | Substantially Equivalent (difference deemed non-critical) |
| Contrast Ratio (typ.) | 1400:1 | 1400:1 | 1400:1 | 1100:1 | Substantially Equivalent (difference deemed non-critical) |
| Native Resolution | 2048 x 1536 | 2048 x 1536 | 1600 x 1200 | 1600 x 1200 | Substantially Equivalent |
| Power Capacity | <50W | <80W | <50W | <70W | Substantially Equivalent (both comply with IEC standards) |
| Operating Temp. | 0°C ~ 40°C | 0°C ~ 40°C | 0°C ~ 35°C | 0°C ~ 40°C | Substantially Equivalent |
| Operating Humidity | 8% ~ 80% (non-condensing) | 20% ~ 80% | 8% ~ 80% (non-condensing) | 20% ~ 80% | Substantially Equivalent |
| Other (Dimensions, Network Interface, etc.) | Comparable or identical. | Comparable or identical. | Comparable or identical. | Comparable or identical. | Substantially Equivalent |
| Safety Standards | IEC 60601-1, IEC 60601-1-2 | Compliant | IEC 60601-1, IEC 60601-1-2 | Compliant | Substantially Equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
This is an LCD monitor, not an AI/ML diagnostic algorithm that processes medical data. Therefore, there is no "test set" of medical images or patient data, nor is there "data provenance" in the sense of country of origin of patient data or retrospective/prospective studies. The "testing" involves verifying the monitor's physical, electrical, and performance specifications against industry standards and the predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As this is a medical display device, not an AI/ML diagnostic device interpreting images, there is no "ground truth" based on expert consensus on diagnoses. The "truth" lies in the adherence to technical specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of patient data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This is a medical display device, not an AI diagnostic tool. MRMC studies are used to assess diagnostic performance of algorithms (with or without human readers).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm in this product for standalone performance evaluation.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for this device revolves around objective engineering and performance metrics (e.g., brightness levels, resolution, contrast ratio, compliance with electrical safety standards, etc.), not clinical diagnoses or outcomes.
8. The Sample Size for the Training Set
Not applicable. This is a medical display device; there is no AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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