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The SonoSurg Ultrasonic Surgical System is indicated for use in surgical procedure in neurosurgery where dissection, fragmentation, emulsification and aspiration of soft tissue are desirable.

This system consists of the SonoSurg Generator (SonoSurg-G2 set), SonoSurg Irrigation Unit (SonoSurg-IU), SonoSurg Transducer (SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source. Do not use this system for any purpose other than its intended use.

The subject SonoSurg is an ultrasonic surgical device designed to be used with Generator Irrigation Unit and Transducer and ultrasonic surgical instruments to dissect, fragment, enulsify and aspirate tissue in the neurosurgical field. This system consists of the SonoSurg Senerator (SonoSurg-G2 set), SonoSurg Imigation Unit (SonoSurg-IU), SonoSurg-Transducer(SonoSurg-T2L-MS), and SonoSurg ultrasonic surgical instruments, and is designed to be used with a separate surgical suction source.

This submission is for a 510(k) premarket notification for the SonoSurg Ultrasonic Surgical System. The document does not describe a study to establish acceptance criteria or demonstrate device performance through clinical trials or specific performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Here's a breakdown of the requested information based on the provided text:

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

The provided documentation does not include a table of acceptance criteria or specific performance metrics with reported results for the SonoSurg Ultrasonic Surgical System. The demonstration of safety and effectiveness is primarily through substantial equivalence to predicate devices, supported by non-clinical tests for design and materials.

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

Not applicable. The submission relies on non-clinical tests and a comparison with predicate devices, rather than a test set with patient data.

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. There is no test set in the conventional sense that would require expert-established ground truth.

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

Not applicable.

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 device is an ultrasonic surgical system, not an AI-assisted diagnostic or imaging device that would typically involve human readers.

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

Not applicable. This device is an ultrasonic surgical system, not an algorithm, and is intended for use with a human medical professional.

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

Not applicable. The evaluation is based on non-clinical tests and comparison to predicate devices, not on a ground truth derived from clinical data.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable.

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