(42 days)
The Digital X-ray Detector DFP4343C7 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.
Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique. DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set. DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
The provided text describes a 510(k) submission for the Digital X-ray Detector DFP4343C7, asserting its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria tables or detailed information about a study proving the device meets specific performance criteria as typically found in clinical validation reports.
The document states that "Clinical considerations according to FDA 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' was performed. All test results were satisfactory." This is a high-level summary and does not provide the granular details requested in your prompt.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor the detailed information about the study design, sample sizes, ground truth establishment, or expert involvement. The document focuses on demonstrating substantial equivalence through non-clinical and general clinical considerations rather than presenting a standalone performance study with specific endpoints and acceptance criteria.
Based on the provided text, the following information can be extracted partially, but much of the requested detail is missing:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The text generally states that "All test results were satisfactory" for both non-clinical and clinical considerations without detailing specific criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The text mentions "Clinical considerations" were performed but does not specify the sample size, type (prospective/retrospective), or origin of any clinical data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided in the document. There is no mention of experts, ground truth establishment, or their qualifications for any clinical evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the document. There is no information about adjudication methods.
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 provided in the document and not applicable. This device is a digital X-ray detector, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable in the AI sense. The device is a digital X-ray detector. Its "performance" would relate to image quality, dose efficiency, and physical characteristics, rather than an "algorithm only" diagnostic performance in the way AI algorithms are evaluated. The document states "All test results were satisfactory" for non-clinical testing which typically includes various performance measures for detectors.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in the document. Given the nature of a digital X-ray detector (image acquisition hardware), "ground truth" might refer to phantoms or standard reference images for assessing image quality, but this detail is not specified for any clinical or non-clinical evaluation.
8. The sample size for the training set:
- Not applicable/Not provided. This device is a hardware detector, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set is relevant for this type of device.
In summary, the provided document is a 510(k) summary focusing on demonstrating substantial equivalence, mainly through compliance with safety, electrical, mechanical, and environmental standards, and general clinical considerations. It does not include the detailed performance study data, acceptance criteria, or methodological specifics typically found in a clinical validation report for a diagnostic device, especially one involving AI or complex performance claims.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.