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The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.

SONOCA 300 is an upgraded version of the SONOCA III having K9942095.

During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.

The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.

Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.

The provided text describes a 510(k) premarket notification for a medical device called Sonoca 300, an ultrasonic surgical instrument. However, the document does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, sample sizes for test or training sets, ground truth establishment, or details about expert involvement.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sonoca III) by confirming the modified device's intended use has not changed and that it complies with various electrical and medical device safety standards.

Therefore, I cannot fulfill all parts of your request with the provided input. Below, I will present the information that is available based on the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics for the Sonoca 300. Instead, its acceptance is based on compliance with established safety and compatibility standards, and its substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a performance study with a test set of data. The evaluation is based on compliance with standards and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

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

Not applicable. The document does not describe a study involving adjudication for a test set.

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 instrument, not an AI-assisted diagnostic tool involving human "readers."

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

Not applicable. This information is relevant for AI/software devices. The Sonoca 300 is a hardware surgical instrument.

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

Not applicable. The "ground truth" for this device's regulatory acceptance is its compliance with established safety and performance standards and its substantial equivalence to a legally marketed predicate device, rather than a clinical ground truth established for diagnostic accuracy.

8. The sample size for the training set

Not applicable. The document does not describe a study with a training set for an algorithm or model.

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

Not applicable. The document does not describe a study with a training set for an algorithm or model.

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