(140 days)
The Concentrix MX-AC High-Speed Handpiece is used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.
The Concentrix MX-AC High-Speed Handpiece is a pneumatically driven, non-fiber optic, 2/3 line fixed backend handpiece that is capable of reaching rotational speeds of 302,000 rpms at a recommended air pressure of 32 PSI. The handpiece is constructed of stainless steel, including the internal air and water tubes which provide drive air to the turbine assembly and cooling water to the work site. The stainless steel and aluminum air driven turbine assembly provides spin to the bur and incorporates steel lubricated bearings and a push button autochuck. The burs used with the Concentrix MX-AC High Speed Handpiece are ISO 1797-1, type 2 burs. Only burs with hardened, tempered steel shanks or carbide shanks should be used.
This document is a 510(k) premarket notification for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable.
The document discusses the substantial equivalence of the Concentrix MX-AC High-Speed Handpiece to predicate devices. The "performance data" section outlines tests conducted to demonstrate functional performance and safety, but these are for the mechanical device itself, not an AI algorithm.
Here's a breakdown of the relevant information provided, while noting the requested AI-specific details are not present:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table with specific acceptance criteria and reported device performance in the way one might expect for a quantitative AI/ML study (e.g., sensitivity, specificity thresholds). Instead, it states that the device's functional performance and safety were evaluated against established international standards.
| Acceptance Criteria (Implied by standards) | Reported Device Performance |
|---|---|
| Conformance to ISO 14457:2012 (Dentistry—Handpieces and Motors) | Test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 14457:2012. |
| Conformance to ISO 60601-1:2005 (Medical Electrical Equipment – Part 1: General requirements for basic safety and essential performance) | Test results confirm that the Concentrix MX-AC High-Speed Handpiece conforms to the requirements of ISO 60601-1:2009. |
| Biocompatibility: Non-cytotoxic, non-sensitizing, and non-irritating (per ISO 10993-5, ISO 10993-10, ISO 10993-12, and FDA Guidance) | Biocompatibility tests (cytotoxicity, sensitization, irritation) indicate the device is non-cytotoxic, non-sensitizing, and non-irritating. |
| Sterilization validation (per ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010)) | Sterilization validation for the handpiece (incorporating the turbine assembly) was performed in accordance with these standards. |
| Cleaning and disinfection validation (per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling") | Cleaning and disinfection validation was conducted per the FDA Guidance Document. |
| Risk Analysis (per ISO14971:2012 Medical devices - Application of risk management to medical devices) | A risk analysis for the Concentrix MX-AC High-Speed Handpiece was developed using ISO14971:2012. (This implies risks were identified and addressed to an acceptable level as per the standard, but specific findings are not detailed in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable. The performance data refers to physical testing of the device, not a data-driven test set for an algorithm.
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):
This is not applicable as there is no ground truth or expert review for an AI/ML device mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's performance would be the physical measurements and observations of its mechanical and biological characteristics as defined by the referenced ISO/AAMI standards.
8. The sample size for the training set:
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.
In summary, the provided document is a 510(k) summary for a physical medical device (dental handpiece), not an AI/ML product. Therefore, the specific questions related to AI/ML device studies, ground truth, and data sets are not relevant to this document. The device meets its acceptance criteria by conforming to established international standards for physical, mechanical, and biocompatibility performance.
§ 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.