(70 days)
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.
The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system.
This appears to be a 510(k) clearance letter from the FDA for a dental X-ray system (Orthophos 3/3 Ceph/3 DS), issued in 1999. This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a robust study proving performance as one might find for a novel AI/software as a medical device (SaMD) cleared under a different pathway or with more recent guidance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types is not available within the provided text segments. The FDA 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and intended use, rather than requiring extensive clinical performance studies with detailed acceptance criteria as would be expected for a novel AI device today.
To answer your questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not describe specific performance acceptance criteria for the Orthophos 3/3 Ceph/3 DS or report its performance against such criteria. It states that the device is "substantially equivalent" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document does not describe any specific test set, its sample size, or data provenance.
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 Available. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. The document does not describe any test set or adjudication method.
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 Applicable / Not Available. This device is a traditional X-ray system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been conducted. The document does not mention any MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Available. This device is hardware (an X-ray system), not a standalone algorithm. The document does not describe any standalone algorithm performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. The document does not refer to ground truth data.
8. The sample size for the training set
- Not Available. The document does not describe any training set as this is an X-ray system, not an AI model.
9. How the ground truth for the training set was established
- Not Available. The document does not describe any training set or its ground truth establishment.
In summary, the provided FDA 510(k) clearance letter for the Orthophos 3/3 Ceph/3 DS, being from 1999 and for a conventional X-ray device, does not contain the detailed performance study information typically required for modern AI/ML medical devices. The focus of this type of clearance is demonstrating substantial equivalence to a pre-existing device.
§ 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.