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510(k) Data Aggregation
(73 days)
MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K
The device is an air-powered dental handpiece providing light through a glass optic rod for use by a trained professional in general dentistry.
The MK-dent® HS Handpiece shares virtually all specifications and design characteristics of the predicate devices. This was done intentionally by the designers and engineers. Only few minor changes implemented to the predicate device make the MKdent® Handpiece more convenient to use but do not affect the performance, safety or effectiveness of it.
This document describes the 510(k) summary for the MK-dent® High Speed Dental Handpiece. It's important to note that this is a traditional 510(k) for a medical device (a dental handpiece), not an AI/ML device. Therefore, the questions regarding acceptance criteria, study design, ground truth, and expert evaluation typically associated with AI/ML performance studies are not directly applicable in the same way.
However, I can extract information related to how equivalency and safety/effectiveness are established for this type of device, which serves a similar function to "acceptance criteria" for traditional devices.
1. A table of acceptance criteria and the reported device performance
For traditional medical devices seeking 510(k) clearance, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant voluntary standards. The reported device performance is implicit in its claim of substantial equivalence and compliance with these standards.
| Acceptance Criteria (Demonstrated by) | Reported Device Performance (Claimed by Applicant) |
|---|---|
| Substantial Equivalence: Device shares virtually all specifications and design characteristics with predicate devices. | "In all respects, the MK-dent® Handpiece is substantially equivalent to one or more air-powered dental handpieces currently marketed in the USA." |
| Biocompatibility: Constructed of materials of the same specifications as the predicate device. | "The handpiece is constructed of materials of the same specifications as the predicate device to ensure biocompatibility." |
| Sterilization Efficacy: Ability to repeatedly adequately sterilize the device confirmed by validation protocol. | "The ability to repeatedly adequately sterilize the device has been confirmed by validation protocol." |
| Compliance with ISO Standards: | "The handpiece conforms to applicable ISO standards." Specifically: |
| - ISO Standard 7785-1: High speed dental turbines | (Implicitly meets by claiming overall ISO compliance) |
| - ISO Standard 1797: Shank dimensions | (Implicitly meets by claiming overall ISO compliance) |
| - ISO Standard 3964: Coupling device | (Implicitly meets by claiming overall ISO compliance) |
| - ISO Standard 27785: Sound level | (Implicitly meets by claiming overall ISO compliance) |
| - ISO Standard 27785: Water coolant | (Implicitly meets by claiming overall ISO compliance) |
| - ISO Standard 1797: Spindle strength | (Implicitly meets by claiming overall ISO compliance) |
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 provided in the document. For traditional 510(k)s, there isn't typically a "test set" in the sense of a dataset processed by an algorithm. Instead, the device itself is tested to ensure compliance with standards and equivalence to predicates. The document doesn't detail any specific testing methodology or sample sizes for performance or safety testing beyond the statement regarding sterilization validation.
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 information is not applicable and therefore not provided. The concept of "ground truth" and expert review as applied to AI/ML performance is not relevant for this traditional dental handpiece 510(k) submission. Safety and effectiveness are demonstrated through adherence to engineering specifications and industry standards, and substantial equivalence to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are relevant for expert review of data, which is not described in this submission.
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 information is not applicable and therefore not provided. This is a traditional medical device, not an AI-powered one. MRMC studies are used to evaluate the impact of AI on human interpretation, which is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. This device is a manual dental handpiece and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and therefore not provided. The "ground truth" for a dental handpiece's performance is its physical characteristics, material properties, and functionality as defined by engineering standards and demonstrated through testing, rather than a diagnostic or interpretive outcome requiring ground truth establishment.
8. The sample size for the training set
This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As this is not an AI/ML device, there is no "training set" or ground truth associated with it in this context.
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