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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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The Burbank Tenaculum is an accessory used in conjunction with the Vascular Control Systems Transvaginal Doppler Probe. The device is intended to seize and hold the cervix and to hold and secure the Transvaginal Doppler Probe in place, while performing audible Doppler procedures.

The Burbank Tenaculum is a stainless steel, ring-handled instrument with a hook at the distal end of one arm and a guide rod attached to the distal end of the other arm. The proximal end of the guide rod is threaded to guide insertion of the Vascular Control Systems Transvaginal Doppler Probe (TDP) into the vagina and secure the TDP in place. A uterine sound is brazed at the distal end of the guide rod intended to be inserted through the cervical opening into the uterine cavity.

The provided text describes a medical device, the Burbank Tenaculum, seeking 510(k) clearance. This means it is claiming substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria through extensive clinical trials. Therefore, the information typically associated with acceptance criteria and a study to prove they are met (like a multi-reader multi-case study, detailed ground truth establishment, or specific performance metrics with statistical analysis) is not present in this document.

Instead, the document focuses on demonstrating that the Burbank Tenaculum is as safe and effective as its predicate devices based on design similarities and intended use.

Here's an analysis based on the information provided, specifically addressing your points where possible:

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

The document does not provide a table of explicit, quantifiable acceptance criteria or reported device performance in the manner one might expect for a new, higher-risk device. The clearance is based on substantial equivalence to predicate devices. The "reported device performance" is essentially the qualitative claim that it meets its product specifications and does not raise new safety or effectiveness issues, similar to already marketed devices.

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

No test set sample size or data provenance is mentioned. The clearance is based on design and material comparisons to predicate devices, and internal design control procedures.

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

Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 is a medical instrument (tenaculum), not an AI device or imaging analysis tool. No MRMC study was performed.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

The concept of "ground truth" as it applies to diagnostic or AI devices is not relevant here. The ground for substantial equivalence is the design, materials, intended use, and functioning characteristics comparison to existing, legally marketed predicate devices, and the claim that it meets its own product specifications.

8. The sample size for the training set

Not applicable. As a physical instrument, there is no "training set" in the machine learning sense. The "training" essentially comes from engineering design, material selection, and manufacturing processes, guided by existing device standards and performance of predicates.

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

Not applicable. There is no training set mentioned. The "ground truth" for its design and manufacturing would be established through engineering specifications, material properties, and adherence to quality systems and design controls (as mentioned: "The Burbank Tenaculum has been designed and tested per design control procedures and was found to meet its product specifications and does not raise new issues of safety, effectiveness, or performance of the product.").

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