(155 days)
OralID™ is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.
OrallD™ is a battery operated (CR123A), hand-held, oral illumination and examination light designed for use by dental and medical professionals to be used as an adjunctive tool for fluorescence visualization of oral mucosal tissue. OralID™ accessories include two pair of filtered eyewear for both the clinician and patient.
The provided document is a 510(k) summary for the OralID™ device, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not present a detailed study on the device's performance against specific acceptance criteria in terms of diagnostic accuracy or clinical effectiveness.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but does not provide quantitative acceptance criteria or detailed results for these tests in terms of clinical performance. Instead, it focuses on technical and safety aspects.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Safety | Conforms |
| Thermal Safety | Conforms |
| Optical Wavelength | Conforms |
| Optical Power Testing | Conforms |
| Beam Quality | Conforms |
| Electrical Safety | Conforms to IEC 60601-1-2 |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance testing mentioned appears to be related to technical specifications and safety rather than a clinical study with a test set of patient data.
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 provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any indication of an AI component in the OralID™ device. The device is a physical illumination and examination light.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The OralID™ device is an adjunctive tool for human examination; it is not an algorithm-only device, so this question is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document, as no clinical study with ground truth establishment is detailed.
8. The sample size for the training set
This information is not provided in the document. The device description and performance testing do not suggest a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 872.6350 Ultraviolet detector.
(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.