(84 days)
The MK-dent® Low Speed Handpieces are dental handpieces for use by a trained professional in general dentistry.
The MK-dent® Low Speed Handpieces are compatible to air and electric drives. The handpieces are available in several versions. For example, the LS 2011L is an angled handpiece providing light through a glass optic rod, the LS 2001 has no glass optic rod, and the LS1011 is non-angled.
The provided text describes a 510(k) summary for the MK-dent Low Speed Handpieces and Accessories. However, it does not contain information regarding the acceptance criteria, specific studies, or performance metrics that would typically be found for a device requiring performance evaluation for 510(k clearance.
This document focuses on establishing substantial equivalence for a Class I dental handpiece, meaning the device's acceptable performance is largely derived from its similarity to existing, legally marketed predicate devices, and adherence to recognized standards.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in this type of submission.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Shares virtually all specifications and design characteristics with predicate device (A-dec/W&H Synea Low Speed (K993526)). | The MK-dent® Low Speed Handpiece shares virtually all specifications and design characteristics with the predicate device. Materials are of the same specifications to ensure biocompatibility. |
| Biocompatibility | Constructed of materials of the same specifications as the predicate device. | Materials of the same specifications as the predicate device (MK-dent® High Speed Dental Handpiece K021250, K032234) were used to ensure biocompatibility. |
| Sterilization | Ability to repeatedly adequately sterilize the device. | Confirmed by validation protocol. (No specific sterility assurance level (SAL) or organism reduction specified in this summary). |
| Voluntary Standard Compliance | Conformance to ISO Standard 7785-2 (Low speed dental handpieces) | Device conforms to ISO Standard 7785-2. |
| Conformance to ISO Standard 1797 (Shank dimensions) | Device conforms to ISO Standard 1797. | |
| Conformance to ISO Standard 3964 (Coupling device) | Device conforms to ISO Standard 3964. | |
| Conformance to ISO Standard 27785 (Water coolant) | Device conforms to ISO Standard 27785. | |
| Conformance to ISO Standard 1797 (Spindle strength) | Device conforms to ISO Standard 1797. |
Missing Information: For this device, the "performance" is largely demonstrated by meeting existing international standards and being equivalent in design and materials to a predicate. There are no quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical endurance values) reported in this summary beyond the general statement of conformance to standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not mentioned. This submission does not describe a clinical performance study with a test set of data. The "study" mentioned is focused on compliance with standards and a sterilization validation protocol.
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/Not mentioned. This type of information is not relevant for this Class I device submission, which doesn't involve complex image analysis or diagnostic claims requiring expert adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned.
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/Not mentioned. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not mentioned. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not mentioned as a "ground truth" in the clinical sense. The "ground truth" for this device's acceptance is its adherence to international standards (ISO) and demonstrable substantial equivalence to a predicate device, as well as validated sterilization protocols.
8. The sample size for the training set
- Not applicable/Not mentioned. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not mentioned.
§ 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.