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The MASTERtorque LUX 8900 L is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The MASTERtorque LUX 8900 L air-driven handpieces are 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, and provided with a fiber optic light system. The devices can be sterilized by the steam autoclave method. Through the MULTIflex coupling connected to a dental unit, the MASTERtorque LUX 8900 L receives the air for high speed turbine, the cooling water and air for cutting treatment through pouring holes and light for illumination the operation area. The MASTERtorque LUX 8900 L is equipped with the Direct Stop Technology which reduces the stopping time of the high speed turbine and so of the bur. The back suction also will be reduced due to the Direct Stop Technology. Additionally the MASTERtorque LUX 8900 L will be supplied with an exchange filter for the water lines inside of the dental air-driven handpiece. The exchange filter filters the spray water inside the product. The filter is considered to be a spare part. If there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions.for use, this spare has to be exchanged. Further one there is a jet needle supplied with the MASTERtorque LUX 8900 L. By using this part the operator is able to clean the spray holes in the head of the product if there is an insufficient amount of cooling water out of the MASTERtorque LUX 8900 L according to the instructions for use.

The provided text describes a 510(k) premarket notification for a dental handpiece, the MASTERtorque LUX 8900 L. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in the prompt, which is typical for a study demonstrating a device meets acceptance criteria, is largely not applicable to this document.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the way a clinical study would define them (e.g., a specific sensitivity or specificity threshold). Instead, it compares the technological characteristics and performance of the MASTERtorque LUX 8900 L to its predicate devices to demonstrate substantial equivalence.

Table of Performance Characteristics (from original document):

The "acceptance criteria" here are implicitly that the device's characteristics and performance are comparable to the predicate devices and comply with relevant international standards. The "reported device performance" is the direct listing of these characteristics.

Study Information (Not Applicable to this 510(k) Preamarket Notification)

1. Sample size used for the test set and the data provenance: This section of the document states: "Non-Clinical Test Data: Performance tests according to the international standards for dental air-driven handpieces have been conducted to determine the conformance to the state of the art." It also states: "Clinical Test Data: Clinical testing has not been conducted on this product." Therefore, there is no "test set" in the context of clinical data. For non-clinical performance tests, no sample size or data provenance is detailed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used. "Ground truth" for the non-clinical performance tests would be defined by the standards and engineering measurements.

3. Adjudication method for the test set: Not applicable, as no clinical test set was used.

4. 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 dental handpiece, not an AI-assisted diagnostic device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance data, the "ground truth" would be established by the specifications and measurement techniques dictated by the relevant ISO standards (ISO 7785-1, ISO 7405, and ISO 9168).

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission, which focuses on demonstrating substantial equivalence to existing devices through non-clinical performance testing and comparison of technological characteristics. It explicitly states that no clinical testing was conducted. Therefore, most of the requested information regarding clinical study design, sample sizes, expert involvement, and ground truth establishment from clinical data is not present and not required for this type of regulatory submission. The "study" mentioned for acceptance is implicitly the non-clinical performance testing against international standards for dental air-driven handpieces.

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