(338 days)
KaVo QUATTROcare is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.
The KaVo QUATTROcare is an aerosol product with hydrocarbon propellants and lubricant and flavor/odor ingredients for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to their sterilization.
The provided documentation for the KaVo QUATTROcare device does not contain a study that presents specific acceptance criteria and detailed performance data in the typical format found for medical device evaluations measuring metrics like sensitivity, specificity, accuracy, etc. This is because the device, a dental handpiece accessory for maintenance, was evaluated for substantial equivalence based on comparisons of formulation and intended uses to a predicate device (KaVo Spray), rather than through performance testing against pre-defined quantitative criteria.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Criterion: Substantial equivalence to predicate device (KaVo Spray) regarding formulation and intended use. | Conclusion: "Based on the information in the notification KaVo America believes that QUATTROcare is substantially equivalent to the claimed predicate (i.e., KaVo Spray, a pre-amendments product)." |
| Intended Use: Internal cleaning, purging of old lubricant, for maintenance of rotating dental and surgical instruments. | The device's description and indications for use align with the intended purpose, being a dental handpiece accessory for maintenance (cleaning, lubrication). |
| Safety: General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates an expectation of compliance rather than |
a specific performance metric. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No formal test set involving device performance data on a specific sample size of biological or simulated cases was conducted. The evaluation was based on a comparison of the device's characteristics (formulation, intended use) to a predicate device.
- Data Provenance: Not applicable. No specific country of origin or retrospective/prospective nature of data for a "test set" is mentioned as it wasn't a performance study.
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. Ground truth, in the context of device performance, was not established by experts adjudicating cases for a test set. Substantial equivalence was determined by regulatory review based on product description and comparison to a legally marketed predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring an adjudication method.
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 device is a dental handpiece maintenance accessory, not an AI-assisted diagnostic or therapeutic tool where MRMC studies involving human readers aiding AI would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As noted above, this device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the regulatory approval was effectively the established safety and effectiveness of the predicate device (KaVo Spray) based on its pre-amendment market clearance. The comparison was focused on the new device's formulation and intended use being similar enough to the predicate to warrant similar regulatory standing.
8. The sample size for the training set:
- Not applicable. There was 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. There was no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or evaluation that proves the KaVo QUATTROcare meets its acceptance criteria is a substantial equivalence determination process, as outlined by the FDA under 510(k) regulations.
Instead of a traditional performance study with a test set and quantitative metrics, the manufacturer (KaVo America) demonstrated substantial equivalence to a legally marketed predicate device (KaVo Spray, a pre-amendments product) by comparing:
- Formulation: Both devices are aerosol products with hydrocarbon propellants and lubricant/flavor/odor ingredients.
- Intended Use: Both are designed for the routine maintenance (cleaning, lubrication, purging of old lubricant) of dental and surgical instruments prior to sterilization.
The acceptance criteria were met when the FDA, based on the submitted information, concluded that the KaVo QUATTROcare was substantially equivalent to the predicate device. This implies that the differences between the new device and the predicate do not raise new questions of safety or effectiveness. The FDA's letter officially confirms this determination.
§ 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.