(16 days)
The BIO-RAY SDX digital x-ray system is intended to be used with standard x-ray systems to collect dental x-ray photos and convert them into electronic data that may be stored, viewed, and manipulated by dentists for the diagnosis of the tecth, jaw and oral structures with the use of computer imaging sollware provided by other 30 parties, readily available from numerous sources.
This device is only to be sold as a prescription device sold to doctors or dental dealers selling directly to doctors,
Digital Dental Intraoral X-Ray Sensor This device is intended to be used for the dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
The provided document is a 510(k) summary for the Bio-Ray SDX Digital X-Ray System, a dental intraoral x-ray sensor. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance studies of AI/ML-enabled devices.
Therefore, most of the requested information cannot be extracted from this document regarding acceptance criteria and performance studies. This document is a regulatory submission for a traditional medical device (an intraoral x-ray sensor), not an AI/ML device, and thus the structure of its validation is different.
However, based on the information provided, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided 510(k) summary. Acceptance criteria for a device like this would typically involve image quality metrics (e.g., spatial resolution, contrast resolution, signal-to-noise ratio), dose reduction capabilities, and mechanical/electrical safety standards. The document states the device is "substantially equivalent" to a legally marketed predicate device, implying it meets similar performance and safety standards, but no specific criteria or performance data are reported.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided 510(k) summary regarding a specific performance test set. The submission focuses on device description and indications for use, not a clinical or technical performance study with a distinct test set of images or patients.
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):
This information is not available in the provided 510(k) summary. Ground truth establishment with experts is usually part of a performance study, which is not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided 510(k) summary.
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:
This information is not available in the provided 510(k) summary. The Bio-Ray SDX Digital X-Ray System is described as a device to "collect dental x-ray photos and convert them into electronic data" and is used with "computer imaging software provided by other 3rd parties." It is not an AI-enabled device itself, and therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its specific submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not available in the provided 510(k) summary. As it's not an AI-enabled device, a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not available in the provided 510(k) summary.
8. The sample size for the training set:
This information is not available in the provided 510(k) summary. Training sets are relevant for AI/ML models, which this device is not stated to be.
9. How the ground truth for the training set was established:
This information is not available in the provided 510(k) summary.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.