(87 days)
Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.
Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.
This exemption is for a low-speed dental motor attachment, a mechanical device. The provided text doesn't describe a study with acceptance criteria and performance metrics in the way one would for an AI/ML medical device. The 510(k) submission primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, particularly highlighting a design change from lubricated to non-lubricated bearings and bushings.
Therefore, many of the requested fields are not applicable to this type of device and submission.
Here's an attempt to address the prompt based on the available information, noting where information is not present:
Description of Acceptance Criteria and Study for K983574
The device under review, StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS, is a mechanical dental device. The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with quantitative acceptance criteria against a defined ground truth for medical diagnostic accuracy. The core "acceptance criteria" appear to be related to functional equivalence and safety, particularly concerning the change to "non-lubricated bearings and bushings."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from Submission) | Reported Device Performance (Inferred from Submission) |
|---|---|---|
| Functional Equivalence | Operation identical to predicate devices. | "Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power to the attachments through a geared drive train for various dental procedures." |
| Intended Use Equivalence | Intended use identical to predicate devices. | "The intended use is identical to that of the predicate low speed motor attachments," which includes "drilling and preparation of dental cavities for restoration, such as fillings... disking, cavity and crown preps, polishing, post and pin drilling and pin setting." |
| Material Equivalence | Materials similar to predicate devices. | "Materials used to manufacture the components are similar." |
| Safety (Non-Lubrication) | Redesign to non-lubricated doesn't compromise function or safety. | "The differentiation between the predicate devices and the submitted is the redesign of standard lubricated bearings to non-lubricated bearings and bushings." (Implied acceptance based on FDA clearance, but specific performance data on "lubefree" aspect is not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the furnished 510(k) summary. Given the nature of the device (mechanical dental attachment), the "test set" would likely refer to engineering evaluations or bench testing, not a clinical data set in the way AI/ML devices are validated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is generally not applicable to the substantial equivalence pathway for a mechanical device like this. Ground truth for diagnostic performance, as applies to AI/ML devices, is not a concept used in this submission.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to this type of medical device submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML) where human reader performance is a key metric, which is not the case for a low-speed dental motor attachment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a mechanical instrument; there is no "algorithm" or standalone "AI" component to evaluate.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as understood for diagnostic AI/ML devices is not applicable here. The "truth" for this device revolves around its functional performance, material compatibility, and intended use matching those of legally marketed predicate devices, which would have been assessed through engineering specifications and potentially bench testing rather than clinical ground truth labels.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" for a mechanical device like this in the context of an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" or associated ground truth for a mechanical device.
§ 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.