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Quill™ MONODERM™ Knotless Tissue-Closure Device is institution where the use of absorbable sutures is appropriate.

The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter

The provided text describes a medical device, the Quill™ Monoderm™ Knotless Tissue-Closure Device, and its 510(k) submission for clearance. However, it does not contain information about a study that establishes acceptance criteria and proves the device meets those criteria in the context of AI/ML device performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. This process typically involves non-clinical laboratory performance testing to show that the new device (in this case, an additional suture diameter size) performs comparably to the predicate and meets relevant standards (like USP monograph for absorbable sutures).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, acceptance criteria, sample sizes for test/training sets, ground truth, experts, adjudication methods, or MRMC studies. These details are not present in the provided text.

The closest relevant information is about the performance tests conducted to demonstrate substantial equivalence, which primarily involve non-clinical laboratory testing.

Here's what can be extracted from the document:

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

• Acceptance Criteria (Implied): Conformance to the USP monograph for absorbable sutures (as applicable).
• Reported Device Performance: "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is substantially equivalent to the predicate device."
• Additional Tests Performed: In vitro post-hydrolysis tensile testing and in vivo resorption testing.

The following questions cannot be answered from the provided text as they pertain to AI/ML device performance studies, which are not described:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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