(26 days)
Claris i310D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.
Claris i310D comprises of a light (0.1 Ibs), small (8.3" x 0.85"), and ergonomic handpiece. The handpiece consists of a focusing mechanism and a capture button to assist the doctor in taking intraoral or full face images of the patient. The handpiece connects to the computer via USB 2.0 port. A cradle is provided to allow for on-off functions. Claris i310D has a digital resolution (720x480 pixels) to capture images at 60 degrees field of view. Images may be stored using third party software vendors.
The provided text describes a 510(k) summary for the Claris i310D Intra Oral Camera System and Accessories. The submission claims substantial equivalence to a predicate device (Claris i310, 510k# K032341) rather than presenting a performance study with specific acceptance criteria as would be typical for new, non-substantially equivalent devices or AI/ML-based devices.
Therefore, many of the requested details are not applicable as the submission relies on demonstrating similarity to an already approved device.
Here's a breakdown based on the provided document:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" and "reported device performance" in the context of a de novo clinical study with quantitative metrics is not explicitly present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The "performance" aspect is framed as a comparison of technological characteristics.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Comparison Result) |
|---|---|
| Indications for use are identical or very similar | Identical |
| Target population is identical or very similar | Identical |
| Design is similar | Similar |
| Materials are identical or similar | Identical |
| Performance is similar | Similar |
| Sterility is identical or similar | Identical (being not applicable as well) |
| Biocompatibility is identical or similar | Identical |
| Mechanical safety is similar | Similar |
| Chemical safety is identical or similar | Identical (being not applicable as well) |
| Anatomical sites are identical or similar | Identical |
| Human factors are similar | Similar |
| Energy used and/or delivered is similar | Similar |
| Compatibility with environment and other devices is similar | Similar |
| Standards met are identical or similar | Identical |
| Electrical safety is identical or similar | Identical |
| Thermal safety is similar | Similar |
| Radiation safety is similar | Similar |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) submission seeking substantial equivalence based on technological characteristics, not a clinical performance study with a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in this type of submission.
- Adjudication method for the test set: Not applicable.
- 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. This device is an intraoral camera, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical camera device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the technological characteristics and safety profile of the predicate device.
- The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) summary for a medical device (intraoral camera) seeking market clearance through the substantial equivalence pathway. It does not present a de novo performance study with acceptance criteria, test sets, or ground truth establishment in the way typically associated with AI/ML or novel diagnostic devices. Instead, the "study" is a comparison of the device's technical specifications and intended use against a legally marketed predicate device to demonstrate that it is "as safe and effective."
§ 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.