(303 days)
MDK high-speed handpieces are used for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. MDK low-speed handpieces used for teeth cutting, cavity and crown preparations and polishing teeth. All the devices are designed for use by a trained professional in the field of general dentistry.
The MDK handpieces are dental hand pieces for use by a trained professional in the field of general dentistry. They are air-powered handpieces that are reusable and have a fiber optic light system (some models do not have this feature.). The MDK handpieces are supplied with water, air and light through the tube and dental treatment units. The MDK handpieces offer high-speed handpieces and low-speed handpieces according to rpm. The high-speed handpieces with fiber optic have 11 models and those without fiber optic have 10 models. The low-speed handpieces are divided into 3 types: contra angle handpieces provided with and without a fiber optic light system, and straight handpieces. The contra angle handpieces with fiber optic have 4 models and those without fiber optic have 10 models. The straight handpieces have 2 models. The MDK handpieces are hand-held, channeled instruments that are powered by compressed air delivered through a hose to an air channel in the handpieces. This impels the turbine in the head of the handpiece to revolve. The bur of the high speed handpieces can rotate up to 400,000 rpm and the bur of the low speed handpieces can rotate up to 100,000 rpm. Dental burs (not part of this 510k) can be inserted into the chuck system of each handpiece (push button, latch, screw, snap-on or tip-lock chuck options). The low-speed handpieces are used with the air motors (20.000 rpm) made by our company and offer various gear ratio (1:1(constant), 20:1(speed reduction), 30:1(speed reduction), and 1:5(speed increase)). The high-speed handpieces are used with the following compatible couplings made by the third party manufacturers. The headpieces are made of titanium and stainless steel, and must be cleaned and sterilized between use by the user.
I am sorry, but the provided document does not contain the detailed information needed to fully answer your request regarding acceptance criteria and study details for an AI/ML device.
The document is a 510(k) premarket notification for MDK Handpieces (dental handpieces), which are mechanical devices, not AI/ML software. Therefore, the "acceptance criteria" and "study" mentioned in this document refer to the performance of these mechanical dental handpieces against established standards for such devices, and not to the performance of an AI/ML algorithm.
Specifically, the document discusses:
- Device Name: MDK Handpieces (high-speed and low-speed dental handpieces)
- Regulation Number: 21 CFR 872.4200
- Regulation Name: Dental Handpiece and Accessories
- Product Code: EFB
- Predicate Devices: Other legally marketed dental handpieces.
- Performance Data: States that bench tests were performed and "passed the pre-set criteria." These tests include:
- Bur release force test
- Reverse analysis report for compatibility with third-party couplings
- Sterilization validation test (in accordance with ISO standards)
- Performance test (in accordance with ISO 14457)
- Biocompatibility test (in accordance with ISO 10993-5)
- Compatibility test for third-party couplings
Therefore, I cannot extract the following information which is specific to AI/ML device studies from this document:
- A table of acceptance criteria and reported AI device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Whether an MRMC comparative effectiveness study was done for AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
- Sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices based on fundamental design, principles of operation, materials, performance specifications, and sterilization methods, primarily through physical and biocompatibility testing.
§ 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.