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TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

This document is a 510(k) Summary for the TRAUS SUS20, a piezo surgery engine set. It details the device's characteristics and its substantial equivalence to a predicate device, TRAUS SUS10. Since this is a submission for a medical device (bone cutting instrument), the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than a quantifiable performance metric (like sensitivity or specificity) for a diagnostic AI. The study presented here is primarily a comparison of technical characteristics and compliance with recognized standards, and not a clinical study involving human subjects or AI-specific performance metrics.

Here is an analysis based on your request, as much as can be extracted from the provided text for a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and substantial equivalence to a predicate device. "Device performance" is shown through bench testing of key operational parameters.

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

This document describes a premarket notification (510(k)) for a conventional medical device, not an AI device or a diagnostic test involving a "test set" of patient data in the typical sense.

• Sample Size: Not applicable. The "test set" refers to the physical device components and their performance in bench tests (e.g., electrical safety, EMC, performance parameters) and comparison with a predicate device. The performance tests would use a sample of the manufactured device.
• Data Provenance: Not applicable in the context of patient data. The provenance of the data for this submission would be internal testing reports, external testing laboratory reports (for standards compliance), and comparison data from the predicate device (TRAUS SUS10, K151171) and a reference device (Compact Piezo LED, K151023) from Saeshin Precision Co., Ltd. and Mectron Spa, respectively. Given the context of a 510(k) submission, this data is generally prospective in terms of the testing done for the new device, but relies on existing data for the predicate devices.

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

Not applicable for this type of device submission. "Ground truth" in the context of diagnostic AI refers to clinically validated diagnoses from expert readers, pathology reports, or robust outcome data. For the TRAUS SUS20, the "ground truth" for the performance tests would be the established scientific and engineering principles behind accurate measurement and functional operation, validated by qualified engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in studies where human readers independently interpret images/data and then reconcile disagreements, which is not relevant for this device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for diagnostic devices, particularly in medical imaging, to assess reader performance with and without an AI aid across multiple cases and readers. The TRAUS SUS20 is a surgical instrument, not a diagnostic device.

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

Not applicable. This device is a physical surgical engine set, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable. The "truth" for this device rests on:

• Engineering Specifications and Standards: The device performs according to its design specifications (e.g., vibration frequency, output power) and meets recognized international standards for electrical safety, EMC, and biocompatibility.
• Predicate Device Equivalence: The functional and safety characteristics are demonstrated to be substantially equivalent to an already legally marketed device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning system, and therefore does not have a "training set" in the computational sense.

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

Not applicable, as no training set exists for this device.

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