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Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Weck Hem-O-Lok™ ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-o-Lok™ causes hemostasis through vessel ligation. The modified XL size clip is a larger version of the existing Hem-o-lok clip.

This looks like a 510(k) premarket notification for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data to prove acceptance criteria in the way a new AI/software device might.

Based on the provided text, there is no information available regarding "acceptance criteria" for device performance in the context of a study, nor is there a study described that proves the device meets such criteria. This document is a regulatory submission for a physical medical device (a ligating clip), not an AI/software device, and thus the questions about AI-specific metrics and study designs are not applicable.

Here's why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on technological characteristics being the same as or equivalent to a predicate device, rather than quantitative performance metrics against specific acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of performance evaluation as you might find for an AI device.
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 establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The document describes the Hem-O-Lok® Ligating Clip (specifically, a modified XL size clip) and asserts its substantial equivalence to previously cleared Weck Hem-o-lok® clip sizes. The primary argument is that the technological characteristics are the same as or equivalent to the predicate device, and a dimensional specification change does not adversely affect safety and effectiveness.

To clarify, this type of regulatory submission (510(k)) for a conventional medical device typically involves:

• Comparison to a predicate device: Demonstrating that the new device is as safe and effective as a legally marketed device.
• Performance Benchmarking (if applicable): For some devices, specific bench testing or engineering evaluations might be conducted to confirm that the changes (e.g., in dimensions) do not compromise key functional aspects like clip strength, locking mechanism, material integrity, etc. However, the provided text does not detail such studies or specific quantitative acceptance criteria for those tests.
• No AI or software component: The questions about AI-specific studies and metrics are entirely irrelevant to this device and its submission.

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