(127 days)
Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
The Belmont QUOLIS 5000 SERIES DENTAL UNIT is a modification of the existing Belmont Dental Unit, Model 2000 series and Model 6000 series. It is a Dental Operative Unit and Accessories.
The provided text is a 510(k) premarket notification for a dental operative unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The device is a physical dental unit, not an AI algorithm or diagnostic tool that would typically involve a test set, ground truth, expert adjudication, or MRMC studies.
Here's an analysis based on the information provided, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units, which presumably meet these standards. |
| ISO-7494-2:2003 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO-7494-1:2004 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
Explanation: The primary method for demonstrating that this device meets its performance "acceptance criteria" (which are outlined as specific international standards for medical electrical equipment and dental equipment) is by proving "Substantial Equivalence" to previously cleared predicate devices. The document states that a comparison (Attachment 2, not provided here) indicates the QUOLIS 5000 is substantially equivalent to the Belmont 2000 Series and Model 6000 Series Dental Units. This means that if the predicate devices meet these standards, then the new device, being substantially equivalent, is also considered to meet them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a substantial equivalence submission for a physical dental unit, not a study involving a test set of data for an algorithm. There is no "test set" in the context of an AI or diagnostic device performance evaluation. The "data provenance" would refer to the technical specifications and comparison data of the device itself and its predicate, not 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)
- Not Applicable. As above, there is no "test set" or "ground truth" to be established by experts in the context of a dental operative unit's substantial equivalence. The "experts" involved would be regulatory reviewers (FDA) and potentially engineers/designers from the manufacturer who performed the comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" or "adjudication method" as this is not a diagnostic or AI performance study.
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. This is a physical dental unit and does not involve AI assistance for human readers/clinicians, nor does it involve a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical dental unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. There is no "ground truth" in the sense of clinical reference standards for an AI or diagnostic device. The "truth" in this context is that the device, through its design and specifications, adheres to relevant safety and performance standards equivalent to predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth in that context.
§ 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.