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The Sorin VascuLoop is used for proximal and distal ligation of vessels during endoscopic vessel harvesting procedures.

The VascuLoop Two Tie Endoscopic Ligation System is used during endoscopic vessel harvesting to ligate both ends of the vessel being harvested at the sites where it is to be cut. The cannula allows the ligation loops to be placed and tightened from a single central incision. The product consists of a nylon cannula, tapered at both ends, with a braided polyester suture (B. Braun/Aesculap PremiCron®, 510(k) cleared by K012201) that has a closable loop tied in one end with the free end through the cannula. This assembly is packaged in a paper envelope and sealed in a Tyvek - polv coextrusion pouch with appropriate labeling. The product will be sterilized using Ethylene Oxide gas.

The provided text describes a medical device, the VascuLoop Two Tie Endoscopic Ligation System, and its substantial equivalence to a predicate device. However, it does not contain information about formal acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that would typically be seen for a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is a common pathway for medical device approval in the US. This means the primary "acceptance criterion" is that the new device is as safe and effective as the predicate device. The evidence provided is largely comparative.

Therefore, many of the requested categories (sample size, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not applicable or not explicitly stated in this type of submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The text mentions "functional performance testing" and a "simulated use cadaver study." It does not specify how many cadavers or how many ligations were performed.
• Data Provenance: The "simulated use cadaver study" implies a prospective, controlled experimental setting, likely in a laboratory rather than a clinical setting. The country of origin is not specified, but given the US submission, it's presumed to be within a regulatory framework compatible with the FDA.

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

• This information is not provided. For this type of device (a surgical tool), "ground truth" would likely be established through objective measurements of ligation integrity, ease of use, and mechanical strength in the cadaver study, rather than through expert consensus on diagnostic interpretations. The evaluators of the cadaver study are not described.

4. Adjudication method for the test set

• Not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's subjective interpretation involved, such as in diagnostic imaging studies to establish ground truth for ambiguous cases. For a mechanical device performance study, objective measurements are usually the primary evidence.

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

• No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by the AI. The VascuLoop is a surgical tool, not a diagnostic AI.

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

• Not applicable. This device is a physical surgical tool and does not involve an algorithm or AI. Its performance is always "human-in-the-loop," as a surgeon uses it.

7. The type of ground truth used

• For the "functional performance testing" and "simulated use cadaver study," the ground truth would likely be based on:
  • Objective Measurements: Such as tensile strength of the ligated vessel, integrity of the knot, ease of deployment, and absence of damage to surrounding tissue, compared to established benchmarks or the predicate device.
  • Observational Data: From the cadaver study regarding the practical application and outcome of using the device.

8. The sample size for the training set

• Not applicable. This device is a surgical tool, not an AI/ML algorithm that requires a training set.

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

• Not applicable. No training set for an algorithm is involved.

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