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The SURGmatic S15 L Pro handpiece is intended for:

• Oral, jaw and facial surgery
• Tooth extraction procedures
• Root resection
• Osteotomy
• Removal of carious material
• Tooth, cavity and crown preparations
• Processing of fillings

The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.

The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).

The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.

The provided document is a 510(k) premarket notification for a dental handpiece (SURGmatic S15 L Pro). Unlike submissions for AI/ML-driven medical devices that involve complex algorithms and require extensive performance studies, this document focuses on demonstrating substantial equivalence to existing predicate devices based on common technological characteristics, intended use, and adherence to established international standards.

Therefore, many of the questions regarding acceptance criteria and performance studies in the context of AI/ML or diagnostic devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily relies on non-clinical bench testing against recognized industry standards to demonstrate that the new device performs comparably to its predicates and meets safety and performance requirements.

Here's an attempt to answer the questions based on the information available in the document, highlighting where the requested details are not relevant to this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not present specific "acceptance criteria" in the format of quantitative thresholds for device performance against a particular medical outcome, as might be seen for an AI diagnostic tool. Instead, acceptance is demonstrated by adherence to established international standards for dental handpieces and by demonstrating substantial equivalence to predicate devices in typical performance characteristics.

The "reported device performance" is implicitly demonstrated through the device complying with the standards listed. The acceptance criteria are the criteria outlined in these standards.

The document states: "Performance bench testing according to international standards for Dental Handpieces has been conducted to determine conformance..." and lists the standards. This implies that the device met the requirements of these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified in terms of patient or clinical samples, as this was a non-clinical, bench-testing submission. The "test set" would refer to the physical units of the device tested in the lab. The document describes "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," which implies a sample of devices tested. The exact number is not provided.
• Data provenance: Not explicitly stated regarding origin or type (retrospective/prospective), as it's non-clinical bench testing. The manufacturer, KaVo Dental GmbH, is based in Germany.

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. For a dental handpiece, "ground truth" as it relates to diagnostic accuracy or clinical outcomes is not established by human experts in the same way as for an AI/ML algorithm. Performance is assessed against engineering specifications and international standards through bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., ground truth for image-based diagnostics), which is not relevant for this device.

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 dental instrument, not a diagnostic AI/ML system, and therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a standalone mechanical device. The concept of "algorithm only" or "human-in-the-loop" performance does not apply. The device's "standalone" performance is assessed by its ability to meet the non-clinical performance standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For a dental handpiece, the "ground truth" for performance relates to engineering specifications and international standards. For example, bur extraction force must meet a minimum specified in DIN EN ISO 14457; light illumination must meet DIN EN ISO 14457. Biocompatibility is "ground-truthed" by adherence to ISO 10993 series. There isn't a "pathology" or "outcomes data" ground truth in the same sense as for a diagnostic device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. Not an AI/ML device.

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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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