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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems flostat™ Clamp. The device is intended to seize and hold the cervix and to hold and secure the flostat Clamp in place, during audible Doppler procedures.

This Tenaculum is only indicated for use with the flostat Clamp and Transvaginal Doppler Probe for bilateral uterine artery detection and temporary control of bleeding during conservative gynecologic surgery such as laparoscopic myomectomy.

The Burbank Tenaculum is a ring-handled instrument with a tooth at the distal end of one arm and a guiderod attached to the distal end of the other arm. The proximal end of the guiderod is threaded to guide insertion of the Vascular Control Systems flostat Clamp into the vagina and secure the Clamp in place.

A uterine sound, at the distal end of the guiderod, is intended for insertion through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, and its regulatory clearance process through a 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific study-related details requested in your prompt.

The document is a "Summary of Safety and Effectiveness" and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results that would typically include acceptance criteria and specific statistical outcomes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:

• "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications." This is a general statement and does not provide specific acceptance criteria or study details.
• "The Burbank Tenaculum does not raise new issues of safety, effectiveness, or performance of the product." This reinforces the substantial equivalence claim but doesn't offer performance metrics.

To answer your request, I would need a document that specifically details the design verification and validation studies, including the test protocols, acceptance criteria, results, and statistical analyses performed for the device.

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