(5 days)
The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™M Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.
Lubricator: This information is detailed on the manufacturing drawings and photographs included in the body of this submission.
Lubricant: ClearView™ Dental Handpiece Lubricant is a liquid lubricant specifically intended for use with the ClearView™ Dental Handpiece Lubricator for the purpose outlined above. Detailed information is contained in the body of this submission.
The provided text describes a 510(k) summary for the ClearView™ Dental Handpiece Lubricator and Lubricant, which is a submission to the FDA seeking market clearance based on substantial equivalence to existing predicate devices. This type of submission focuses on comparing the new device's characteristics, safety, and effectiveness to legally marketed predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data like those found for novel or higher-risk medical devices requiring clinical trials.
Therefore, based on the provided text, many of the requested details about acceptance criteria and studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable because such a detailed study was not presented or required for this type of 510(k) submission.
Here's the breakdown of what can be extracted or inferred from the text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) substantial equivalence submission for a Class I device, specific quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new, high-risk device with a clinical trial are not explicitly stated or provided in the document.
Instead, the acceptance criteria for this type of submission are implicitly "substantial equivalence" to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The reported "performance" is a qualitative comparison demonstrating this equivalence.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: The device serves the same purpose as the predicate devices. | The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™ Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization, which aligns with the purpose of predicate devices. |
| Technological Characteristics Equivalence: The device operates on similar principles and has similar features to the predicate devices. | Lubricator Comparison: Both the ClearView™ and the Assistina have a reservoir for lubricant, a cover to contain exhaust, a method of connecting handpieces, push button operation, a hose and connection to a pressurized air supply. Both devices use pressurized air for power and do not have electrical components. |
| Lubricant Comparison: Both ClearView™ Dental Handpiece Lubricant and Phase Change Dental Lubricant are liquids suitable for lubrication of dental handpieces. | |
| Safety and Effectiveness Equivalence: The device is as safe and effective as the predicate devices and does not raise new questions of safety or effectiveness. | The differences between ClearView™ and the predicate devices do not raise questions regarding safety and effectiveness. The device employs the same technological characteristics to support its intended use. Both lubricant types are considered completely safe under normal usage and have no expected hazards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. The document does not describe a "test set" in the context of performance testing with a specific sample size. The review focuses on comparing the device's design and intended function to predicate devices, not on a clinical or performance study with a distinct test dataset.
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. No ground truth establishment for a test set is described. The entire submission is reviewed by the FDA, with the "ground truth" essentially being the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No test set or expert adjudication process is described for this type of 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
Not Applicable. This is a mechanical device (lubricator and lubricant), not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a mechanical device; there is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in a 510(k) substantial equivalence submission for this type of device is the established safety and effectiveness of the legally marketed predicate devices. The applicant's submission aims to demonstrate that its new device is "substantially equivalent" to these already-approved devices, meaning it works comparably and is just as safe and effective.
8. The sample size for the training set
Not Applicable. No "training set" in the context of machine learning or complex algorithm development is mentioned or relevant for this mechanical device submission.
9. How the ground truth for the training set was established
Not Applicable. As no training set is described, the process for establishing its ground truth is also not applicable.
§ 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.