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510(k) Data Aggregation
(89 days)
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
1417WCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
1417WCA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. The wireless LAN((IEEE 802.11a/g/n) communication signals images captured to the system and improves the user operability through high-speed processing. This X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WCA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
This submission for the 1417WCA Digital Flat Panel X-ray Detector from Rayence Co., Ltd. does not contain a typical acceptance criteria table with performance metrics and a detailed study proving the device meets those criteria in the way AI/CADe devices often do. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (1417PCA) through non-clinical and clinical comparison.
The "acceptance criteria" here are implicitly tied to demonstrating performance equivalent to the predicate device in key imaging characteristics and a general review by an expert for clinical images.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (1417WCA vs. 1417PCA) |
|---|---|
| Non-Clinical Performance: | |
| Modulation Transfer Function (MTF) equivalence: MTF of 1417WCA should be substantially equivalent to 1417PCA. | Reported: "The comparison of the MTF for 1417WCA and 1417PCA detector demonstrated that the MTF of the 1417WCA detector performed almost same with 1417PCA. Therefore the overall resolution performance and sharpness of 1417WCA is almost same with 1417PCA." |
| Detective Quantum Efficiency (DQE) equivalence: DQE of 1417WCA should be substantially equivalent to 1417PCA. | Reported: "1417WCA demonstrated almost same DQE performance with 1417PCA at various spatial frequencies and provides almost same Signal-to-Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency. At the lowest spatial frequency, the DQE test for 1417WCA and 1417 PCA resulted 74%, respectively." |
| Noise Power Spectrum (NPS) equivalence: NPS of 1417WCA should be substantially equivalent to 1417PCA. | Reported: "The NPS test for 1417WCA and 1417 PCA exhibited almost identical performance between the two devices." |
| Overall Image Quality (Non-Clinical): Image quality of 1417WCA should be substantially equivalent to 1417PCA at the same patient exposure setting. | Reported: "Therefore, the image quality of 1417WCA is substantially equivalent to 1417PCA at the same patient exposure setting." |
| Clinical Performance: | |
| Clinical Image Quality equivalence: Clinical images from 1417WCA should be comparable to 1417PCA as determined by expert review. | Reported: "Based on the non-clinical and clinical consideration test and the outcome of a comparative review by an expert for both devices, we can claim the substantial equivalency between 1417WCA and its predicate device, 1417PCA in terms of image quality." (Specific metrics or thresholds for "comparable" are not provided, as it relies on expert opinion). |
| Safety and EMC: Conformance to relevant electrical, mechanical, environmental and electromagnetic compatibility standards. | Reported: "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1:1988 + A1:1991 + A2:1995... and EMC testing were conducted in accordance with standard IEC60601-1-2:2007... The equipment also complies with the standard FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB. All test results were satisfactory." |
2. Sample size used for the test set and the data provenance:
- Non-Clinical Test Set: The text mentions "non-clinical test report... prepared and submitted to FDA separately to demonstrate the substantial equivalency between two different detectors." It states the MTF, DQE, and NPS tests were conducted "by using the identical test equipment and same analysis method described by IEC 62220-1." While it doesn't give a specific number of images or runs, these tests typically involve standardized phantoms and measurement methodology, not patient data.
- Clinical Test Set: Clinical images were obtained from "both devices" (1417WCA and 1417PCA). It also states "both the test (1417WCA) and control group (1417PCA) are evaluated according to similar age group and anatomical structures." The specific number of clinical images (sample size) is not provided.
- Data Provenance: The document does not explicitly state the country of origin or whether the clinical data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: "a licensed US radiologist" (singular) was used.
- Qualifications: "a licensed US radiologist." No specific years of experience or specialty were detailed beyond "US radiologist."
4. Adjudication method for the test set:
- The text describes a "comparative review by an expert." It does not specify a formal adjudication method like 2+1 or 3+1. The single radiologist provided an "expert opinion" on the clinical images.
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 MRMC study was performed. This submission is for a digital flat panel X-ray detector itself, not an AI/CADe system. The clinical evaluation involved a single radiologist performing a comparative review of images from the new device and the predicate device for substantial equivalence, not assessing human performance with or without AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an imaging hardware component (digital flat panel X-ray detector), not an algorithm or AI system. Its "standalone" performance is characterized by physical imaging metrics like MTF, DQE, and NPS.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (MTF, DQE, NPS), the ground truth is derived from physical measurements using standardized phantoms and test methods (IEC 62220-1).
- For the clinical image comparison, the ground truth for establishing "substantial equivalency in terms of image quality" was based on the expert opinion/review of a single licensed US radiologist. It's not explicitly stated that they were looking for specific pathologies or outcomes, but rather overall diagnostic image quality comparison.
8. The sample size for the training set:
- Not applicable. This device is a hardware detector and does not use a "training set" in the context of machine learning or AI algorithms. Its performance is inherent to its physical design and manufacturing.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, there is no training set for this hardware device.
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