(27 days)
Claris i310 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 i310 comprises of a light (0.1 lbs), small (8"x0.86"), and ergonomic handpiece along with a docking station.
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 a docking station via a cable. The docking station in turn can connect directly to a monitor. PC, or a printer via a S-Video or a standard composite connection.
Claris i310 is also available in a wireless option.
It uses high definition imaging (494 lines/inch) to capture images at 60 degrees field of view.
Images may be stored using third party software vendors.
Claris i310 includes also an optional footswitch.
The provided text describes a 510(k) summary for the Claris i310 Intra Oral Camera System and Accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a rigorous study on the device's performance.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, and MRMC studies are not available in the provided document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific functional or performance metrics (e.g., image resolution, accuracy in detecting conditions, error rates) | Not Available. The document states "Performance: Similar" to the predicate device. It mentions "high definition imaging (494 lines/inch)" but doesn't provide specific performance criteria or tests against them. |
2. Sample size used for the test set and data provenance:
- Sample Size: Not available. No specific test set or study validating performance is described.
- Data Provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Number of Experts: Not applicable, as no specific performance test set with ground truth is described.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no specific performance test set is described.
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:
- MRMC Study: No, an MRMC study was not done or described. This device is an intra-oral camera, not an AI-powered diagnostic tool, so such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Standalone Performance: No, a standalone algorithm performance study was not done or described. The device is purely an imaging tool, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as no specific performance test with ground truth is described.
8. The sample size for the training set:
- Sample Size: Not applicable. This device is a hardware imaging system, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable.
Summary of Device and 510(k) Claims:
The Claris i310 Intra Oral Camera System and Accessories is an imaging device intended to provide dentists and patients with a view of the mouth before and after dental procedures to assist in describing procedures and showing results.
The 510(k) submission (K032341) claims substantial equivalence to the predicate device "DIGITAL DOC from Digital Doc. Inc." (510k # K981663). The basis for this claim is a comparison of technological characteristics, finding them "Identical" or "Similar" across various categories, including:
- Indications for use: Identical
- Target population: Identical
- Design: Similar
- Materials: Similar
- Performance: Similar (stated as "high definition imaging (494 lines/inch)")
- Biocompatibility: Similar
- Mechanical safety: Similar
- Chemical safety: Similar
- Anatomical sites: Identical
- Human factors: Similar
- Energy used and/or delivered: Similar
- Compatibility with environment and other devices: Similar
- Where used: Identical
- Standards met: Similar
- Electrical safety: Similar
- Thermal safety: Similar
- Radiation safety: Similar
The document does not provide a detailed "study that proves the device meets the acceptance criteria" in terms of specific performance metrics because the 510(k) pathway for this type of device relies on demonstrating equivalence to a legally marketed predicate, rather than novel performance claims requiring extensive new clinical or performance studies. The "study" here is essentially the comparison of technological characteristics to the predicate device, showing that it performs similarly and is thus safe and effective for its stated intended use.
§ 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.