(76 days)
ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.
The provided document is a 510(k) summary and FDA clearance letter for the ROLENCE Dental High Speed Handpiece, Model: RHP. It does not describe an AI/ML medical device, but rather a traditional medical device (a dental handpiece). Therefore, many of the requested categories for AI/ML device studies are not applicable.
Here's an analysis based on the information provided, addressing the questions where relevant:
1. Table of Acceptance Criteria and Reported Device Performance
The submission refers to international standards for device design and performance verification, rather than specific numerical acceptance criteria and reported device performance values.
| Acceptance Criteria (Reference Standard) | Reported Device Performance (Compliance) |
|---|---|
| ISO7785-1:1997, Dental Handpiece -- Part 1: High-speed air turbine handpieces | Verified function test according to ISO7785-1 |
| ISO13485:2003, Medical Device Quality Management System | Device design steps completed according to ISO13485 |
| ISO14971:2007, Medical devices – Application of risk management to medical devices | Risk Management Report completed according to ISO14971 |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of traditional medical device. The "test set" here refers to the physical device prototypes being tested against engineering standards. The data provenance would be the manufacturing site (Taiwan R.O.C.) where the verification tests were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of an AI/ML device. For this traditional device, the "ground truth" is defined by the technical specifications and performance requirements established in the referenced ISO standards. The individuals conducting the tests would be qualified engineers and technicians.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML device. Device testing against standards doesn't typically involve adjudication.
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 traditional dental handpiece, not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a manual device operated by a human professional.
7. The Type of Ground Truth Used
For this traditional medical device, the "ground truth" for demonstrating substantial equivalence and performance relies on:
- Conformance to International Standards: Specifically, ISO7785-1 for functional verification, ISO13485 for design processes, and ISO14971 for risk management.
- Comparison to Predicate Device: The primary method for establishing substantial equivalence was a comparison of formulations and intended uses with the JINDELL High Speed Air Turbine Handpiece (K062740).
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.