(8 days)
To be used to lubricate air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
DO-ALL is a lubricant designed for use with air-powered dental handpieces. The product is intended to be used prior to handpiece sterilization to lubricate the moving parts inside of the air-powered turbine. The lubricant is not intended to come into contact with the patient and has no therapeutic function.
The provided document pertains to a 510(k) premarket notification for a dental handpiece lubricant and does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI/ML-driven diagnostics.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. The performance testing mentioned is for the lubricated dental handpiece to ensure it continues to meet existing performance standards after being lubricated with the new product. This is a different type of evaluation than what is usually described as "acceptance criteria" for a novel device's inherent performance.
However, I can extract information related to the closest equivalent of "acceptance criteria" and "study" based on the context provided:
1. Table of Acceptance Criteria and Reported Device Performance
The device itself is a lubricant. The "performance" being evaluated is the ability of a dental handpiece lubricated with "DO-ALL" to continue performing according to established standards.
| Characteristic Tested (on Handpiece lubricated with DO-ALL) | Acceptance Criteria (ISO 7785-1:1997(E) & FDA Guidance) | Reported Device Performance (Handpiece lubricated with DO-ALL) |
|---|---|---|
| Extraction force | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Resistance to corrosion | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Torque | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Noise level | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Reprocessing | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Speed | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
| Stall torque | (Implicit: meet standard requirements) | "meet or exceed all of the applicable performances standards" |
Note: The document states "DO-ALL performs as well as the predicate device in head-to-head comparisons" and that lubricated handpieces were "shown to meet or exceed all of the applicable performances standards outlined in ISO 7785-1:1997(E)." The specific quantitative acceptance criteria from ISO 7785-1:1997(E) and the FDA Guidance are not explicitly detailed in the provided text, nor are the specific numerical performance results for the lubricated handpieces. The key finding is the compliance with these standards.
2. Sample size used for the test set and the data provenance
- Test Set Description: The study involved testing "Dental handpieces lubricated with DO-ALL" and comparing their performance to those lubricated with the predicate device.
- Sample Size: The document mentions "Extensive testing illustrated that after 250 use/sterilization cycles the handpiece continued to meet all performance requirements." This implies that at least one or more handpieces were subjected to 250 cycles. The exact number of handpieces or the number of repeat tests for each characteristic is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "performance testing presented in the body of this submission." It is a prospective performance evaluation in a lab setting, not a retrospective analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this type of device and study. The "ground truth" here is objective physical performance measurements of the handpiece against established engineering standards (ISO 7785-1:1997(E) and FDA Guidance), not expert consensus on an interpretation of data.
4. Adjudication method for the test set
This section is not applicable. No expert adjudication was involved as the assessments were objective physical measurements.
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 section is not applicable. This study does not involve human readers, AI, or diagnostic image interpretation. It is a performance study of a mechanical lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. There is no algorithm or AI involved. The study evaluated the mechanical performance of a dental handpiece with the lubricant.
7. The type of ground truth used
The "ground truth" was established by international standards (ISO 7785-1:1997(E)) and FDA Guidance Document on Dental Handpieces, which outline objective performance requirements for dental handpieces measuring various physical parameters (e.g., extraction force, torque, speed, noise level, resistance to corrosion, reprocessing, stall torque).
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is a performance evaluation of a physical product, not a machine learning model.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set.
§ 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.