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Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. 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 structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.

The provided text describes a 510(k) submission for a medical device, the Weck Hem-o-Lok™ Automatic Ligating Clip Applier. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against them.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment are not available in the provided text, as this type of detail is typically part of specific validation reports or clinical studies, not generally found in a 510(k) summary focused on substantial equivalence.

Based on the provided text, here's what can be extracted:

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

• Acceptance Criteria (Implied): The primary "acceptance criteria" for a 510(k) submission are demonstrating substantial equivalence to existing legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: The document states:
  • "The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety."

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

• Not available in the provided text. The document refers to "bench and animal testing" but does not specify sample sizes or data provenance.

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/available. This type of detail is typically for AI/imaging device studies. This device is a surgical instrument. The evaluation would likely involve engineering tests and animal models, reviewed by regulatory bodies and internal engineering/medical staff, rather than "experts establishing ground truth" in the diagnostic sense.

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

• Not applicable/available. As above, this is generally for diagnostic and AI studies, not for a surgical instrument's substantial equivalence pathway.

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 pertains to AI-assisted diagnostic devices, not a surgical ligating clip applier.

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

• Not applicable. This pertains to AI algorithms, not a manual surgical instrument.

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

• Implied Ground Truth: For a device like this, "ground truth" would relate to successful ligation, clip integrity, and lack of adverse events in preclinical (bench and animal) testing. The document states "bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety." This suggests the "ground truth" was established based on the functional performance criteria of the device in these controlled environments, likely involving criteria like clip deployment success rate, clip retention force, and absence of tissue damage or bleeding in animal models. The document doesn't explicitly state the methodology for establishing this.

8. The sample size for the training set

• Not applicable/available. No "training set" in the machine learning sense is mentioned or implied for this mechanical device.

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

• Not applicable/available. As above, no "training set" exists for this type of device submission.

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