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The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

The New Device is a dental operative unit that supplies utilities to and serves as a base for Satelec Bone Cutting Handpiece (K091252, cleared July 22, 2009). The New Device uses Piezoelectric Ultrasound Technology to generate mechanical micro vibrations for bone cutting, with minimal trauma to soft tissue. The device is supplied with Dental Bone Surgery Tips for use in dental surgery, including osteotomy, osteoplasty and implantology. Also, the New Device uses accessories such as Piezoelectric Handpiece, Multifunction Footswitch, Bracket and Irrigation Tubing.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria for the PIEZOTOME SOLO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Size: Not explicitly stated. The document mentions "test bench" evaluations.
• Data Provenance: Not explicitly stated, however, the tests were "internal" and conducted by SATELEC, a French company. It is implied the data is prospective as the evaluations were done for the purpose of a 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The ground truth was established through direct comparison to the performance of a predicate device rather than expert review of clinical data.

4. Adjudication Method for the Test Set:

• Not applicable. The study involved direct performance comparison to a predicate device on a test bench, not human interpretation of results requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on technical performance equivalence to a predicate device, not clinical effectiveness with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, a standalone performance study was done. The "Performances of the New Device have been evaluated on test bench" comparing its technical outputs (currents, frequencies, irrigation flows, leakage currents) directly against the predicate device. This is a standalone evaluation of the device's technical specifications.

7. Type of Ground Truth Used:

• Predicate Device Performance: The "ground truth" for the new device's performance was established by directly comparing its measured technical parameters (currents, frequencies, irrigation flows, leakage currents) to the established performance values of the legally marketed predicate device (Satelec IMPLANT CENTER 2, K091252).

8. Sample Size for the Training Set:

• Not applicable. This device is an operative unit, not an AI/algorithm-driven device requiring a training set in the typical sense for machine learning. The comparison is based on the technical characteristics and performance of the Piezotome Solo against a predicate device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, this is not an AI/algorithm-driven device that uses a training set for model development.

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