(92 days)
The Computed Oral Radiology System is intended for intra-oral x-rav examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-rav dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K041385.
The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new control mechanism differs from the predicate in that image acquisition is initiated via a new hardware trigger residing on the CMOS ASIC. Direct triggering via an x-ray tube continues to be supported as was cleared in K041385. The modification offers an improvement in system-level support. The modification in no way alters the fundamental technology nor intended use.
The provided text is a 510(k) summary for a dental imaging device (Computed Oral Radiology System) and primarily focuses on demonstrating substantial equivalence to a predicate device after a modification. As such, it does not contain the detailed information typically found in a study report proving a device meets specific performance acceptance criteria.
Specifically, the document states: "All validation activities have demonstrated that the predetermined acceptance criteria were met." However, it does not explicitly define these acceptance criteria, nor does it describe the specific studies and their results in enough detail to populate the requested table and answer many of the questions.
Here's a breakdown of what can be inferred and what is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit: The document states "predetermined acceptance criteria were met" but does not define what those criteria were (e.g., specific image quality metrics, diagnostic accuracy thresholds). | Not explicit: The document does not provide specific performance data (e.g., sensitivity, specificity, resolution metrics, contrast ratios) from any studies. It only generally states that "All validation activities have demonstrated that the predetermined acceptance criteria were met." |
| Principal risk: Unintended x-ray exposure (inferred as an acceptance criterion for safety) | Evaluated through "imaging, software validation, and third-party safety testing." (No specific results provided). |
2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "validation studies" but does not provide details about sample sizes or data provenance (country of origin, retrospective/prospective). Given that the modification is related to a control mechanism and not a fundamental change in imaging technology or intended use, it's possible that extensive clinical test sets were not deemed necessary for this specific 510(k) rather than for the initial clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. Ground truth establishment methods, number of experts, and their qualifications are not mentioned.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device is an imaging sensor, not an AI-assisted diagnostic tool. There is no mention of AI or any MRMC studies involving human readers and AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated how "standalone" performance translates to this device. The device is a digital imaging receptor. Performance would relate to image quality, dose reduction, and overall system function, rather than an "algorithm only" performance separate from the human operator. While "imaging, software validation" is mentioned, no specific standalone performance metrics are provided.
7. The type of ground truth used:
- Not specified.
8. The sample size for the training set:
- Not applicable/Not specified. As there's no mention of AI or deep learning, there isn't a "training set" in the typical sense for an algorithm. If "training set" refers to data used for system development and calibration, it is not detailed.
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
In summary: The provided 510(k) pertains to a modification of an already cleared device, specifically "a new control mechanism" for image acquisition. The document emphasizes that the modification "in no way alters the fundamental technology nor intended use." This suggests that the validation focused on ensuring the new control mechanism's safety and functionality, and its compatibility with the existing system, rather than re-proving the core diagnostic performance of the imaging technology. Therefore, the detailed performance study information typically required for a novel diagnostic device is not present in this 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.