(88 days)
Provide access, illumination and allow observation or manipulation of body cavities, hollow organs and canals.
SOPRO feels the S555 Dental Camera is substantially equivalent to the many marketed devices already in commercial distribution. The design of the S555 is virtually identical to the comparative devices, which are listed and displayed in Exhibit 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the sames, SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device.
This 510(k) submission for the SOPRO S555 Dental Camera does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.
The provided document is a 510(k) summary and the FDA's response letter. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, technology, specifications, and intended use. Performance data, clinical studies, or specific acceptance criteria are not detailed within this submission.
Therefore, I cannot provide the requested information, including:
- Table of acceptance criteria and reported device performance: Not present.
- Sample size, data provenance, number of experts, adjudication method for the test set: No test set performance data is described.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable as this is a dental camera, not an AI algorithm.
- Type of ground truth used: Not applicable as no performance study is detailed.
- Sample size for the training set: Not applicable as no AI algorithm or training is discussed.
- How ground truth for the training set was established: Not applicable.
The submission states: "SOPRO feels that these minors differences have no impact on the safe use and/or effectiveness of the device," implying that the substantial equivalence argument, rather than new performance data, is the basis for market clearance.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.