Search Results

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

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.

Ask a specific question about this device

The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.

Not Found

This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.

The key information provided is:

• Trade/Device Name: Acclaim
• Regulation Number: 21 CFR 872.6640
• Regulation Name: Dental Operative Unit and Accessories
• Regulatory Class: I
• Product Codes: NRD and EAY
• 510(k) Number: K042266
• Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.

Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.

Ask a specific question about this device