(347 days)
This system is designed to incise and coagulate soft tissue for laparoscopic and intraabdominal procedures in general surgery
The major components of this system are Generator, Handpiece, and accessories. This SonoSurg generator is supplied the electrical energy to transducer built-in handpiece. The electrical energy is exchanged mechanical energy by ultrasonic vibration at the transducer. The ultrasonic vibration is transferred to the tip of probe. In conjunction with the Generator, the body tissue is incised and coagulated with handpiece.
The provided text "K972114 Olympus SonoSurg System" is a 510(k) summary for a medical device and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.
A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove device performance against predefined acceptance criteria. The document highlights the device's technical specifications and how it compares to existing devices, along with its compliance with voluntary safety standards.
Therefore, most of the information requested in your prompt is not available in this document.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantified performance acceptance criteria through a study.
2. Sample size used for the test set and the data provenance: Not applicable or not provided. This document does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This document does not describe a clinical study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
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. The Olympus SonoSurg System is an ultrasonic surgical system, not an AI diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable or not provided.
8. The sample size for the training set: Not applicable or not provided. This document does not suggest an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established: Not applicable or not provided.
Summary of what is available from the document regarding "acceptance" (in the context of a 510(k)):
The document states that the Olympus SonoSurg System is designed, manufactured, and tested in compliance with Voluntary Safety Standards (IEC 601-1 and IEC 601-1-2, as well as CISPR 11). This compliance, along with demonstrating substantial equivalence to predicate devices, is the primary "acceptance criteria" for a 510(k) submission rather than a performance study.
Conclusion:
The provided 510(k) summary for the Olympus SonoSurg System is a regulatory document focused on substantial equivalence. It does not contain the details of a performance study with acceptance criteria as envisioned in your prompt.
N/A