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Used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

The Allegiance Flexible Vascular Clamp, Version 2 is a reusable device which features a stainless steel handle, flexible shaft and jaws. This clamp is designed to be used with a variety of inserts which gently surround blood vessels and offer differing degrees of atraumatic occlusion. Following the clamping of the blood vessel, the shaft of the device can be bent out of the way to enhance visualization of and access to the operative field.

The provided text describes a medical device, the "Allegiance Flexible Vascular Clamp, Version 2", and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically associated with AI/algorithm performance.

The document is a 510(k) submission, focused on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission generally relies on comparing the new device's design, materials, and intended use to an existing device, rather than conducting new clinical trials or performance studies against defined acceptance metrics for AI.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies. These elements are not present in the provided text.

Based on the information provided, here's what can be extracted, though it doesn't align with the AI/algorithm-focused questions:

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

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the new device (Flexible Vascular Clamp, Version 2) is substantially equivalent to the predicate device (Cosgrove™ Clamp) in terms of:
  • Intended use
  • Performance attributes
  • Atraumatic Jaw design characteristic
  • Materials
• Reported Device Performance: The document states that "All materials used in the composition of the Flexible Vascular Clamp, Version 2 were subjected to performance and physical tests to evaluate the safety, effectiveness". However, no specific performance metrics or results from these tests are reported in the provided text. The document instead emphasizes equivalence to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. The document describes a comparison to a predicate device, not a performance study with a test set composed of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth establishment for a test set is not relevant to this type of regulatory submission.

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

• Not applicable/Not provided.

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/Not provided. This is not an AI device, and no MRMC study is mentioned.

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

• Not applicable/Not provided. This is a physical medical device, not an algorithm.

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

• Not applicable/Not provided. The ground truth concept, as it applies to AI/algorithm validation, is not present here. The basis for approval is "substantial equivalence" to a predicate device, which itself has an established regulatory history.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI device that uses a training set.

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

• Not applicable/Not provided.

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