(72 days)
DentiMax Digital X-ray Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photos and convert them into electronic impulses that may be stored, and manipulated by dentists for the diagnosis of diseases of the teeth, jaw, and oral structures.
Digital Dental intraoral Xray Sensor. This device is intended to be used for dental radiographic examination for the diagnosis of diseases of the teeth, jaw, and oral structures.
The provided text is a 510(k) summary for the DentiMax Digital X-ray Imaging System. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or reader studies.
The 510(k) summary focuses on demonstrating that the DentiMax device has "similar technological characteristics" to a legally marketed predicate device (Accent™ Sensor Digital X-ray System, K050693) and is "equivalent." This is a regulatory pathway that often relies on comparison to existing devices rather than extensive de novo clinical studies with predefined acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions directly from the provided text. The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in a more detailed clinical or performance study report, which is not part of this 510(k) summary.
Here's a breakdown of why each requested item cannot be answered with the given text:
- Table of acceptance criteria and reported device performance: This information is not present. The 510(k) summary makes a general claim of equivalence but does not list specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: No test set or study specific to the DentiMax device's performance against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment process is detailed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not mention an MRMC study. It focuses on device characteristics comparison.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device described is an X-ray imaging system, which inherently involves human interpretation. No mention of an algorithm-only performance study is made.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth is described.
- The sample size for the training set: Not applicable, as machine learning training sets are not mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA 510(k) documentation does not contain the detailed performance study information you are asking for. It focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.
§ 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.