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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.

Weck Closure System's 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 clip is nonabsorbable and is manufactured from polyacetal.

The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

This document is a 510(k) Premarket Notification summary for the Hem-O-Lok® Ligation Clips. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The information provided describes a traditional
medical device (ligation clips), not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study components for AI/ML devices (like sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or not reported in this type of submission for a physical device.

Here's an analysis based on the provided document, addressing the relevant points and noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal "acceptance criteria" and "reported device performance" in the context of a statistical study for efficacy or performance as would be expected for a diagnostic or AI/ML device. For a physical device like a ligation clip, acceptance is typically based on:

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

Not applicable. This is a physical, manually applied surgical device. Its performance is demonstrated through material properties, manufacturing controls, and equivalence to a predicate device, not through a "test set" of data in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective does not apply here.

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

Not applicable. Ground truth, in the context of an AI/ML device for disease detection or measurement, is not relevant for this physical surgical clip.

4. Adjudication method for the test set

Not applicable. An adjudication method for a test set is not relevant for this physical surgical clip.

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 physical surgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth is not a concept applied to the evaluation of a physical surgical clip in this context. The "truth" is its physical and material properties, and its ability to achieve ligation, which is established through manufacturing, standards, and clinical use history of similar devices.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

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

Not applicable. There is no AI/ML algorithm requiring a training set and associated ground truth.

Summary of Study (Substantial Equivalence Determination)

The "study" or justification proving the device meets acceptance criteria (primarily substantial equivalence) is based on the following:

• Comparison to a Predicate Device: The Hem-O-Lok® clip is deemed substantially equivalent to Weck's previous Hem-O-Lok® clips cleared under 510(k) filing number 982941. This means the new device shares similar technological characteristics, intended use, and performance claims as a device already on the market.
• Technological Characteristics: The document states that the technological characteristics are the "same as or equivalent to the predicate device." This includes the polyacetal material used, which is confirmed to be biocompatible.
• Intended Use: The intended use "for procedures involving ligation of vessels or tissue structures" is identical to the predicate.
• Manufacturing and Sterilization: The device is manufactured from polyacetal, is nonabsorbable, housed in a cartridge, sterile-packaged, and sterilized by EtO with a SAL of 10⁻⁶. These are standard practices and properties for such devices, implying compliance with established safety and performance benchmarks.

In essence, the "study" for this device is a demonstration of equivalence to an already legally marketed device, supported by known material properties and manufacturing processes, rather than a prospective clinical trial or performance evaluation against a diagnostic ground truth.

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