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The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.

The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.

The provided text is a Fragment of a 510(k) summary for the Habib™ VesCoag. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics.

Based solely on the provided text, here's what can be extracted and what cannot:

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

The provided document does not explicitly state predefined acceptance criteria for specific performance metrics of the Habib™ VesCoag in a quantifiable way (e.g., "coagulation time < X seconds"). Instead, it states a broader goal:

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

The document does not provide any information on:

• Sample size used for any test set.
• Data provenance (country of origin, retrospective or prospective nature).

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)

This information is not available in the provided text. The document refers to "Performance testing" but does not detail the methodology or the involvement of experts in establishing ground truth.

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

This information is not available in the provided text.

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

This document describes an electrosurgical device for blood vessel coagulation, not an AI-assisted diagnostic tool. Therefore, a MRMC study related to human readers and AI assistance would not be applicable or relevant to this device.

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

This refers to an electrosurgical device that requires human operation, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable.

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

The document does not specify the type of "ground truth" used. Given the nature of the device (coagulation), performance data would likely involve direct measurements of coagulation effectiveness (e.g., vessel occlusion, burst pressure, histological analysis of tissue damage, etc.), but these details are not provided. The phrase "meets design specifications" implies internal, defined performance targets.

8. The sample size for the training set

The concept of a "training set" is relevant to machine learning algorithms. This document describes a physical medical device, not an AI system. Therefore, the concept of a "training set" is not applicable here. The performance data section refers to "performance testing" to ensure the device functions as intended and meets specifications, not an algorithmic training process.

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

As explained above, the concept of a "training set" and its associated ground truth is not applicable to the type of device described in this document.

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