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KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.

This looks like a 510(k) premarket notification for a dental handpiece lubricant/cleaner device. The provided text does not contain any information regarding acceptance criteria, study design, or performance metrics for the KaVo QUATTROcare Modified device. It primarily focuses on the device's description, intended use, and claim of substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.

If you have a different document that details the performance study for K071288, please provide it, and I would be happy to analyze it for the requested information.

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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:

                    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.

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