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510(k) Data Aggregation
(61 days)
4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
These products are intended to be used in displaying digital images for review and analysis by trained medical practitioners. They do not support the display of mammography images for diagnosis.
C44W+ is a 30-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for Ultrasound and General Radiography. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control. 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for erqonomic comfort.
C82W+ is a 31.5-inch TFT color LCD monitor. It is specifically designed to display high quality, high definition images required for diagnostic, interventional radiology and other medical applications. With built-in multi-display modes, it facilitates convenient viewing by doctors of various images, data, and layout of information. The product is designed to be able to meet DICOM 3.14 calibration standards. With features such as brightness stability control, 14 bit image processing technology, and interfaces with external calibration software, it ensures optimal viewing conditions over the life of the display. The specially designed base supports height and tilt adjustments for ergonomic comfort.
C83W+ and C85W+ are 27-inch TFT color LCD monitors. They are specifically designed to provide the high definition images output for general Radiography. The products have been strictly calibrated so they meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel, supporting resolution 3840 x 2160. With built-in brightness stabilization control circuit, make sure the brightness of this monitors are stable in their life, and the products meet the demand of high precision medical imaging.
For C44W+, C82W+, C83W+, C85W+, the only difference is the screen. C83W+ and C85W+ have the same screen, but their customers are different, which results in the two models.
The provided document describes the 510(k) premarket notification for Shenzhen Beacon Display Technology Co., Ltd.'s 4MP/8MP Color LCD Monitors (C44W+/C82W+, C83W+, C85W+). These monitors are intended for displaying digital images for review and analysis by trained medical practitioners, excluding mammography images for diagnosis.
The study presented is a bench test comparison to a legally marketed predicate device, the Eizo Nanao Corporation RadiForce RX440 (K130070). The purpose of the study is to demonstrate substantial equivalence to the predicate device, not necessarily to establish the device's absolute performance against a set of clinical acceptance criteria for diagnosis.
Here is an analysis based on your requested information, referencing the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study targeting specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it focuses on demonstrating equivalence to a predicate device based on technical display characteristics and conformance to relevant industry guidelines (AAPM Task Group 18 (TG18 guideline)).
The "reported device performance" are the results of the bench tests on the proposed devices (C44W+, C82W+, C83W+, C85W+) showing their technical specifications and how they align with or differ from the predicate device. The document generally concludes that the devices are equivalent to the predicate.
Here's a summary of key performance tests conducted, which serve as the basis for their claim of equivalence:
| Acceptance Criteria (based on AAPM TG18 guidelines and general display characteristics) | Reported Device Performance (for C44W+, C82W+, C83W+, C85W+) |
|---|---|
| Measure the spatial resolution expressed as Modulation Transfer Function (MTF) | Not explicitly detailed, but implied to be sufficient. |
| Verify conformance to DICOM GSDF in accordance with TG18 guideline | Explicitly stated that proposed devices are designed to meet DICOM 3.14 calibration standards and pass the exams in AAPM-TG18 4.3 "Luminance Response". The tone between the predicate device and proposed devices are different, but deemed equivalent in this aspect. |
| Measure the luminance non-uniformity characteristics of the display screen (TG18) | Bench tests performed; implied to meet requirements. |
| Measure the chromaticity non-uniformity characteristics of the display screen (TG18) | Bench tests performed; implied to meet requirements. |
| Visually check the presence or absence of miscellaneous artifacts (TG18) | Bench tests performed; implied to meet requirements. |
| Measure maximum, minimum, achievable, and recommended luminance | Max luminance: C44W+ (700 cd/m²), C82W+ (1000 cd/m²), C83W+/C85W+ (800 cd/m²). DICOM calibrated luminance: 500 cd/m² (all proposed). Predicate: Max luminance (750 cd/m²), DICOM calibrated luminance (400 cd/m²). Differences noted, but not considered to affect safety/effectiveness. |
| Measure the temporal response (using panel manufacturer data) | Response time: C44W+ (6 ms), C82W+ (14 ms), C83W+/C85W+ (16 ms). |
| Maximum number allowed for each type of pixel defects/faults | Bench tests performed; implied to meet requirements. |
| Measure the chromaticity at the center of the display screen (5%, 50%, 95% max luminance) (FDA Guidance for FFDMM Systems) | Bench tests performed; implied to meet requirements. |
| Measure the color tracking (primary colors and color gamut) | Bench tests performed; implied to meet requirements. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2. Sample size used for the test set and the data provenance
The study involves bench testing of the devices themselves (C44W+, C82W+, C83W+, C85W+). It's not a study involving patient data or human interpretation. Therefore, "sample size" and "data provenance" in the context of clinical images or patient data are not applicable. The "test set" consists of the physical display units being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a technical performance study of a device (monitor), not a diagnostic accuracy study using medical images interpreted by experts. Therefore, "ground truth" in the context of expert consensus on medical images is not applicable. The ground truth is adherence to technical specifications and industry standards like AAPM TG18. The "experts" involved would be the technical personnel performing the bench testing and evaluating the results against established standards, but their specific number and qualifications are not mentioned in this document.
4. Adjudication method for the test set
"Adjudication method" is not applicable as this is a technical performance study of display monitors, not an evaluation of diagnostic interpretations where consensus among readers would be required.
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, an MRMC comparative effectiveness study was not done. This submission is for medical display monitors, not an AI-powered diagnostic tool. The document focuses on the technical characteristics and equivalence of the monitors to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question refers to AI algorithm performance. Since the device is a medical display monitor and not an AI algorithm, a standalone performance study in that context was not done. The study performed was a technical assessment of the monitor's display capabilities.
7. The type of ground truth used
The "ground truth" for this technical assessment is adherence to technical specifications, industry standards (e.g., DICOM 3.14, AAPM TG18 guidelines), and comparison with the predicate device's established performance. It's not based on pathology, expert consensus on medical images, or patient outcomes data.
8. The sample size for the training set
This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, a "training set" is not applicable.
9. How the ground truth for the training set was established
This question refers to the training of an algorithm. Since the device is a medical display monitor and not an AI algorithm, the concept of establishing ground truth for a training set is not applicable.
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