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510(k) Data Aggregation
(24 days)
The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.
The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), 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.
The document describes a 510(k) premarket notification for several Hisense LCD monitor models (HMD2G21, HMD3G21, HMD5G21). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards, and by demonstrating performance comparable to or better than the predicate devices. The study detailed below focuses on comparing the Hisense monitors' specifications to those of their respective predicate devices.
Here's a consolidated table comparing the proposed Hisense devices (HMD2G21, HMD3G21, HMD5G21) with their identified predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) based on the provided "General Comparison" tables.
| Feature | Acceptance Criteria (Predicate Device Performance) | Hisense HMD2G21 Performance | Hisense HMD3G21 Performance | Hisense HMD5G21 Performance |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography for 2MP/3MP; including digital mammography for 5MP) for review and analysis by trained medical practitioners. | Same as predicate | Same as predicate | Same as predicate |
| Panel Size & Type | 21.3", TFT LCD display (2MP, 5MP); 21.3", TFT LCD display (3MP) | 21.3", TFT LCD display | 21.2", IPS-NEO, antiglare | 21.3", IPS-NEO, antiglare |
| Pixel Pitch | 0.27 mm (2MP); 0.2115 mm (3MP); 0.165 mm (5MP) | 0.27 mm | 0.21075 mm | 0.165 mm |
| Native Resolutions | 1600x1200 (2MP); 2048x1536 (3MP); 2560x2048 (5MP) | 1600x1200 | 2048x1536 | 2560x2048 |
| Brightness | 1650 cd/m2 (2MP); 800 cd/m2 (3MP); 700 cd/m2 (5MP) | 1900 cd/m2 | 1700 cd/m2 | 1200 cd/m2 |
| Contrast Ratio | 850:1 (2MP); 1700:1 (3MP); 800:1 (5MP) | 1400:1 | 1400:1 | 1200:1 |
| Network Interface | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) | USB (1 Up, 2 Downstream) |
| Active Display Size (HxV) | 432mm x 324mm (2MP); 433mm x 325mm (3MP); 422mm x 338mm (5MP) | 432.0mm x 324.0mm | 431.6mm x 323.7mm | 422.4mm x 337.9mm |
| Operating Temp. | 0°C ~ 35°C (2MP); 0°C ~ 40°C (3MP, 5MP) | 0°C ~ 40°C | 0°C ~ 40°C | 0°C ~ 40°C |
| Transport/Storage Temp. | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C | -20°C ~ 60°C |
| Operating Humidity | 8% ~ 80% (non-condensing) | 20% ~ 80% | 20% ~ 80% | 20% ~ 80% |
| Transport/Storage Humidity | 5% ~ 85% (2MP); 5% ~ 95% (3MP, 5MP) | 10% ~ 90% | 10% ~ 90% | 10% ~ 90% |
| Power Capacity | <70W (2MP); ≤40W (3MP); 61W (5MP) | ≤60W | ≤60W | <80W |
| Input Voltage | 100 | DC24V/2.2A (2MP/3MP); DC24V/3A (5MP) | DC24V/2.5A | DC24V/3A |
| Usability | Button operation, LED indicator | Button operation, LED indicator | Button operation, LED indicator | Button operation, LED indicator |
| Mode of Operation | Continuous operation | Continuous operation | Continuous operation | Continuous operation |
| Biocompatibility | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. | No direct/indirect patient contact, no evaluation needed. |
| Sterility | Not needed | Not needed | Not needed | Not needed |
| Electrical & Mechanical Safety & Thermal Safety | Complying with IEC 60601-1 | Complying with IEC 60601-1 | Complying with IEC 60601-1 | Complying with IEC 60601-1 |
| EMC Evaluation | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 | Complying with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study in terms of patient data or image sets. It is a technical comparison (bench testing) between the proposed devices and predicate devices. Therefore, there is no "test set" in the context of clinical images or patient data. The "sample size" implicitly refers to the three models of proposed devices (HMD2G21, HMD3G21, HMD5G21) being compared against their respective predicate models (BARCO Nio 2MP, Nio 3MP, Nio 5MP).
The data provenance is from the manufacturer's (Qingdao Hisense Medical Equipment Co., Ltd.) specifications and the specifications of the predicate devices. This type of comparison is typically based on published technical specifications and internal testing, not retrospective or prospective clinical data. The country of origin for the proposed device manufacturer is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a clinical study involving experts to establish ground truth for image interpretation. The "ground truth" for this submission are the technical specifications and performance characteristics of the predicate devices and the relevant IEC safety standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
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
Not applicable. This submission is for medical display monitors, not an AI or CAD (Computer-Aided Detection/Diagnosis) software. The study is a technical comparison of display performance, not an evaluation of human reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI product.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for this submission is based on:
- Technical Specifications: Published specifications of the predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) and the proposed Hisense devices.
- Regulatory Standards: Compliance with established medical device safety and performance standards, specifically IEC 60601-1 (Electrical, Mechanical & Thermal safety) and IEC 60601-1-2 (Electromagnetic Compatibility - EMC).
- Intended Use Statements: Formal declarations of intended use, which must be comparable to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no AI or machine learning component, so no training set is relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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