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This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures. It is designed for use by a trained professional in the field of general dentistry.

The Maxima PRO 45L air-driven handpieces are air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the gravity steam autoclave methods that have been validated. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine. They also receive cooling water for cutting through one port and light for illumination through another port. Further one there is a jet needle supplied with the Maxima PRO 45L. By using this part the operator is able to clean the spray port in the head of the product if there is an insufficient amount of cooling water out of the Maxima PRO 45L according to the instructions for use. The mechanism of action for the proposed air driven handpieces is as follows: The dental handpieces is an air-driven handpiece which will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. The handpiece is operated by pneumatic pressure applied on the cartridge, providing a rotation between 380,000 and 420,000 rpm. For proper operation, set air pressure on the dental treatment unit at 40 ± 1.45 psi and check with a pressure gauge Air supply must be dry, clean, and uncontaminated. For the cooling water, a minimum of 50 ml/min (pressure 14.5 ± 1.5 psi (1± 0.1) of water is needed. The Multiflex coupling has a bulb which enables thought existing optical fiber in the handpiece, the lighting at the place of action of the drill. Dental burs (not part of this 510(k)) according to ISO 1797-1 type 3 could be inserted into the chuck system of the turbine. The Maxima PRO 45L interacts with the patient through a rotating bur with the patient teeth according to the intended use. The Maxima PRO 45L is providing with connection MULTIflex system. The connectors carry the air for the high speed turbine, the cooling water for cutting treatment and light for illumination from the dental treatment unit. The coupling is an accessory that permits quick exchange of the work equipment and high costeffectiveness when extending your range of instruments. As a matter of course each dental instrument can be ergonomically rotated 360° on the MULTIflex coupling. The MULTIflex connectors are accessories to the medical device which will not be delivered together with the Maxima PRO 45L.

The provided document describes the 510(k) premarket notification for the "Maxima PRO 45L" dental handpiece. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way one might for a novel diagnostic or therapeutic device.

However, I can extract information related to performance testing and equivalence claims based on the provided text.

Here's an analysis of the provided information regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a dental handpiece (a Class I device), the "acceptance criteria" are not detailed in terms of specific clinical endpoints or diagnostic metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs as well as or similarly to the predicate devices on specific operational and safety standards.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data or patient-specific samples. The performance testing was based on non-clinical tests conducted on the device hardware itself. Therefore, a sample size of patient data or data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" for this type of device refers to the physical units of the device subjected to laboratory performance testing (e.g., a certain number of handpieces tested for durability, speed, bur retention, etc.). However, the exact number of units tested is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes physical device performance testing against engineering standards and specifications, not interpretation of clinical data where expert ground truth would be required.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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 is not applicable. The device is an air-powered dental handpiece, a mechanical tool, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI integration, or assessment of human reader improvement with AI assistance was performed or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a mechanical dental handpiece, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device, in essence, is defined by international engineering and performance standards (ISO 14457:2012 and ISO 9168:2009) and by comparative performance data from legally marketed predicate mechanical devices. The device's performance metrics (e.g., idling speed, bur retention force, operating pressure) are measured against the specifications outlined in these standards and compared to the reported characteristics of predicate devices.

8. The sample size for the training set

This is not applicable as the device is a mechanical tool and does not employ a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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