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510(k) Data Aggregation
(21 days)
8MP Color LCD Monitor (C81W+)
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
The C81W+ is an 8MP color LCD monitor for viewing medical images including breast tomosynthesis, digital mammography, ultrasound and general radiography. Its using the latest generation of LED back light panel, with high resolution 4096X2160, built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed throughout its life. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 8MP Color LCD Monitor (C81W+), structured to address your specific points.
Acceptance Criteria and Device Performance Study for 8MP Color LCD Monitor (C81W+)
The provided document describes a 510(k) premarket notification for the 8MP Color LCD Monitor (C81W+), comparing it to a predicate device, the EIZO RadiForce RX850. The core of the acceptance criteria and the study lies in demonstrating substantial equivalence to the predicate device, particularly in performance characteristics relevant to medical image display.
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily relies on comparing the technological characteristics of the proposed device (C81W+) with the predicate device (RadiForce RX850) and then validating these characteristics through bench testing against established guidelines. The "acceptance criteria" are implicitly set by the performance of the predicate device and the standards outlined in the AAPM Task Group 18 (TG18 guideline).
| Acceptance Criteria (Implicit from Predicate & TG18) | Reported Device Performance (C81W+) |
|---|---|
| Intended Use Equivalence: | Met: "totally same as that of the predicate device." |
| Display digital images for review, analysis, and diagnosis by trained medical practitioners, including standard and multi-frame digital mammography and breast tomosynthesis applications. | (Same as predicate) |
| Display Performance/Specifications: | Met/Equivalent: |
| Screen Technology (TFT Color LCD Panel (IPS)) | TFT Color LCD Panel (IPS) |
| Viewing Angle (H: 178°, V: 178°) | H: 178°, V: 178° |
| Resolution (8MP: 4,096 x 2,160) | 8MP (4,096 x 2,160) |
| Aspect Ratio (17:9) | 17:9 |
| Active Screen Size (697.9 mm x 368.0 mm) | 697.9 mm x 368.0 mm |
| Pixel Pitch (0.1704 mm x 0.1704 mm) | 0.1704 mm x 0.1704 mm |
| Maximum Luminance (850 cd/m²) | 850 cd/m² |
| DICOM Calibrated Luminance (500 cd/m²) | 500 cd/m² |
| Contrast Ratio (1450:1) | 1450:1 |
| Response Time (typ.) (20 ms (On/Off)) | 20 ms (On/Off) |
| Backlighting (LED) | LED |
| Grayscale Tones (10-bit input: 1.07 billion colors max; 8-bit input: 16.77 million colors) | (Same as predicate) |
| Luminance non-uniformity (Digital Uniformity Equalizer) | Digital Uniformity Equalizer |
| Video Signal Input: | Met/Equivalent: |
| Input video signals (DVI-D (dual link) x 2, DisplayPort x 2) | DVI-D (dual link) x 2, DisplayPort x 2 |
| Scanning Frequency (H, V) (31 - 140 kHz / 59 - 61 Hz) | (Same as predicate) |
| Power Related Specifications: | Different but assessed as not affecting safety/effectiveness: |
| Power Requirements (AC 100 - 120V, 200 - 240 V: 50 / 60 Hz) | DC24V/9.0A (Difference in built-in vs. built-out power supply) |
| Power Consumption / Save Mode (227 W / Less than 6 W) | 180 W / Less than 5 W (Different design scheme) |
| Power Management (DVI DMPM, DisplayPort 1.1a) | DVI DMPM, DisplayPort 1.2 (Different design scheme) |
| Miscellaneous Features/Specifications: | Different but assessed as not affecting safety/effectiveness: |
| QC software (RadiCS) | Beacon Monitor Manage (Different design scheme) |
| Sensor (Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor) | Backlight Sensor, Integrated Front Sensor, Ambient Light Sensor (Predicate has "Presence Sensor," proposed does not) |
| USB Ports/Standard (1. Upstream, 2. Downstream / Rev. 2.0) | (Same as predicate) |
| Dimensions w/o stand (747 x 430 x 130 mm) | 755 x 433.8 x 99.1 mm (Different housing design due to panel size) |
| Image Quality Conformance to TG18 Guideline: | Met: Bench tests performed and results showed equivalence. |
| DICOM GSDF conformance | Passed |
| Angle dependency of luminance response | Measured and deemed acceptable |
| Luminance non-uniformity characteristics | Measured and deemed acceptable |
| Chromaticity non-uniformity characteristics | Measured and deemed acceptable |
| Chromaticity at center (5%, 50%, 95% max luminance) | Measured and deemed acceptable |
| Display reflections (specular, diffuse, haze) | Measured and deemed acceptable |
| Small-spot contrast ratio | Measured and deemed acceptable |
| Spatial resolution (MTF) | Measured and deemed acceptable |
| Noise (NPS) | Measured and deemed acceptable |
| Pixel aperture ratio | Measured and deemed acceptable |
| Absence of miscellaneous artifacts | Visually checked and deemed acceptable |
| Temporal response | Measured and deemed acceptable |
| Luminance stability | Performance data available |
| Maximum number allowed for each type of pixel defects/faults | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No animal or clinical testing is needed for C81W+." This means there was no "test set" of patient data in the traditional sense involving medical images for diagnostic performance evaluation. The "test set" here refers to the device itself undergoing various technical bench tests.
- Test Set Sample Size: N/A (as it refers to the device undergoing technical tests, not a dataset of medical images).
- Data Provenance: The data comes from bench testing performed on the C81W+ device, following guidelines like AAPM TG18. The country of origin for the device manufacturer is Shenzhen, China. The testing itself is implied to be conducted by or for Shenzhen Beacon Display Technology Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical or retrospective patient data was used, there were no experts establishing "ground truth" for a medical image test set in this context. The "ground truth" for the device's technical specifications is established by internationally recognized standards (like DICOM GSDF, AAPM TG18 guideline) and the specifications of the legally marketed predicate device. The experts involved would be engineers or technicians with expertise in display technology and medical imaging standards, who conducted the bench tests and validated conformance. Their specific number and qualifications are not detailed in this premarket notification.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication by medical experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. The submission explicitly states "No animal or clinical testing is needed for C81W+." This type of study would involve human readers evaluating cases with and without AI (or in this case, a new display) and comparing their diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a display monitor, not an AI algorithm. Therefore, a "standalone algorithm performance" study is irrelevant here. The performance evaluated is the technical display characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Technical specifications derived from established standards (e.g., DICOM GSDF, AAPM TG18).
- Performance data of a legally marketed predicate device (EIZO RadiForce RX850).
- Physical measurements obtained during bench testing of the C81W+ device.
8. The Sample Size for the Training Set
Not applicable. This device is a display monitor, not a machine learning or AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.
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