(126 days)
The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
The MASTERmatic LUX electrical-driven handpieces - MASTERmatic LUX M25 L, MASTERmatic LUX M20 L, MASTERmatic LUX M10 L, MASTERmatic LUX M07 L, MASTERmatic LUX M29 L, MASTERmatic LUX M05 L are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electrical-powered handpieces that are reusable and ergonomically shaped, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the MASTERmatic LUX handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. Dental burs and other attachments according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) will be used with the MASTERmatic LUX handpieces.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from referenced standards) | Reported Device Performance (MASTERmatic LUX) |
|---|---|
| Intended Use/Indications for Use: Removal of carious material, reducing hard tooth structure, cavity & crown preparations, root canal preparations, removal of fillings, processing & finishing tooth preparations/restorations, polishing teeth. Designed for use by a trained dental professional. | Same as acceptance criteria (stated in "Statement of Intended Use" and "Summary of the Technological Characteristics"). |
| Functional Principle: Receives energy, cooling water, air for treatment, and light for illumination via micro motor connected to dental unit, complying with ISO 3964. | Same as acceptance criteria (stated in "Summary of the Technological Characteristics" and "Mechanism of Action"). |
| Air/Water ports: Internal Spray | Internal Spray (stated in "Summary of the Technological Characteristics") |
| Fiberoptics: Must have a light system. | With built-in light system (stated in "Summary of the Technological Characteristics") |
| Speed Range: Up to 200,000 rpm | Up to 200,000 rpm (stated in "Summary of the Technological Characteristics") |
| Rotary Instruments: Compatible with burs, cutters, and other attachments (straight or contra-angle shank) according to ISO 1797-1. | Compatible with burs, cutters, and other attachments (straight or contra-angle shank) according to ISO 1797-1 (stated in "Summary of the Technological Characteristics"). |
| Biocompatibility: Direct and indirect patient-contacting portions must be biocompatible according to ISO 10993-1. | Complies with ISO 10993-1 (stated in "Summary of the Technological Characteristics"). |
| Light Intensity: Approx. 25,000 LUX | Approx. 25,000 LUX (stated in "Summary of the Technological Characteristics"). |
| Bur retention force: Min. 22 N (45 N for straight handpieces) | Min. 22 N (45 N straight handpieces) (stated in "Summary of the Technological Characteristics"). |
| Sterilization: Sterilizable according to ISO 17665-1 (Moist heat). | Sterilizable according to ISO 17665-1 (stated in "Summary of the Technological Characteristics"). |
| Compliance to Standards: ISO 14457 (Dentistry - Handpieces and motors), ISO 1797-1 (Dentistry - Shanks for rotary instruments), ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors). | Complies with ISO 14457, ISO 1797-1, ISO 3964 (stated in "Summary of the Technological Characteristics" and "Non-Clinical Test Data"). |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Non-Clinical Test Data". This indicates that the testing was bench testing and not performed on human subjects. Therefore, there is no "test set" in the context of patient data, nor is there any provenance related to country of origin for such data. The testing was conducted according to international standards for dental gear-driven handpieces.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The device underwent "Non-Clinical Test Data" (bench testing) and "Clinical testing has not been conducted on this product." Therefore, there was no human expert adjudication for a clinical ground truth.
4. Adjudication method for the test set
This section is not applicable. As no clinical studies were performed that required expert adjudication, no adjudication method was used.
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
This section is not applicable. No MRMC study was conducted, as no clinical studies were performed and the device is a dental handpiece, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a dental handpiece and does not involve an algorithm or AI. Performance was assessed through non-clinical bench testing.
7. The type of ground truth used
The ground truth used for performance verification was based on compliance with established international standards for dental devices (bench testing outcomes). This includes:
- ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
- ISO 1797-1 (Dentistry - Shanks for rotary instruments)
- ISO 10993-1 (Biological evaluation of medical devices - Biocompatibility)
- ISO 14457 (Dentistry - Handpieces and motors)
- ISO 17665-1 (Sterilization of health care products - Moist heat)
8. The sample size for the training set
This section is not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This section is not applicable. There is no training set mentioned or implied in the provided document.
§ 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.