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Synergetics Sonotome™ Ultrasonic Aspirator Tips are intended for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, Thoracoscopic Surgery.

Synergetics Sonotome™ Ultrasonic Aspirator Tips are accessories that are attached to the handpiece of an ultrasonic surgical aspirator system manufactured by another company. The tip, which simply transmits power from the system handpiece, is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissues while preserving vessels, ducts and other delicate structures. The main features on the Synergetics Sonotome™ Ultrasonic Aspirator Tips are: A variety of tip diameters, shapes and lengths are available for specific surgical applications. Curved tips are bent so as to provide clear visualization of the surgical site, unobstructed by the handpiece. Individually packaged, sterile tips can be replaced without the need for resterilization of the handpiece. Preaspiration holes in the tips minimize clogging and keep the tip clear of debris.

This document is a 510(k) Premarket Notification summary for the Synergetics Sonotome™ Ultrasonic Aspirator Tips. It specifies the device's intended use, materials, and a comparison to a predicate device.

However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document states: "Validation and verification of the Ultrasonic Aspirator Tips will be accomplished through a combination of analysis and testing. This process will include a Risk Analysis and a mechanical performance test on prototype units."

This indicates that a mechanical performance test was planned or conducted, but no details about the acceptance criteria, the results of the test, or the study methodology are provided in the extracted text.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information about an MRMC comparative effectiveness study or its effect size.
• Information about a standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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