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510(k) Data Aggregation
(261 days)
Ultrasonic Surgical Unit is a piczoelectric device for bone surgery that enables ostcotomy and ostcoplasty techniques to be applied to in dental use.
Sonic Surgeon 300 is an ultrasound generator for use in dental surgery. And this device is used for surgical procedures, including osteonal surgery and in device your and implantation. Boost Mode can be used for mechanical ultrasound treatment in prophylaxis, periodontics or endodontics. The tips can easily be changed during the treatment and can also be cleaned and autoclaved. The Ultrasonic Surgical Unit transforms generated ultrasonic (26±3kHz) energy to the kinetic energy and transmits it to the tip. The generator of the Ultrasonic Surgical Unit performs automatic tuning of the operating frequency, the efficiency of the piezoelectric transducer in the handpiece.
This document describes the safety and effectiveness information of the Sonic Surgeon 300 / Ultrasonic Surgical Unit.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria for performance benchmarks like accuracy, precision, or sensitivity. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety Conformity: Adherence to recognized medical electrical equipment safety standards. | The Ultrasonic Surgical Unit has been manufactured and tested to meet the safety requirements of IEC. The Ultrasonic Surgical Unit complies with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) and IEC 60601-1-2:2001 (Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests). |
| Substantial Equivalence: Demonstrated similarity in intended use, technological characteristics, and performance to a legally marketed predicate device. | The device is deemed "very similar with predicate device, Piezosurgery (K043408), because Sonic Surgeon 300 has the following identical characteristics: intended use, sterilization method used material, electronic input power, frequency, and power output." |
"The performance tests demonstrated that Ultrasonic Surgical Unit performs in a substantially equivalent manner to the predicate device." |
| Intended Use Conformity: The device performs its stated "Indications for Use." | The device is described as "a piezoelectric device for bone surgery that enables osteotomy and osteoplasty techniques to be applied to in dental use." This intended use is consistent with the general description of its function. |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size or test set in the context of a formal clinical or performance study involving patients or a dataset for evaluating an AI model. The "performance tests" mentioned are likely technical evaluations against standards rather than a study on a specific number of cases/patients.
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 or provided. The document describes a device for surgical use and its technical compliance, not an AI or diagnostic tool that requires ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable or provided. The "performance tests" likely refer to engineering and electrical safety testing, not clinical performance evaluation with adjudication.
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 information is not applicable or provided. The device is an ultrasonic surgical unit, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case study evaluating human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable or provided. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable or explicitly stated as ground truth is typically associated with diagnostic or AI performance evaluation. The "ground truth" in this context would be the specifications and requirements of the safety standards (IEC 60601-1, IEC 60601-1-2) and the operational characteristics of the predicate device (Piezosurgery, K043408). The device's performance is measured against these established technical specifications and the functionality of the predicate.
8. The sample size for the training set:
This information is not applicable or provided. The document describes a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable or provided for the same reasons as above.
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