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The OverStitch Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch™ Endoscopic Suturing System and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing either a dual channel or single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix, Suture Cinch and Suture Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

This document is a 510(k) summary for a medical device (OverStitch Endoscopic Suturing System) and thus does not contain the detailed study data, acceptance criteria, or ground truth establishment typically found in a full clinical study report or a premarket approval (PMA) application. A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, often relying on bench testing and comparisons of technological characteristics rather than extensive clinical trials for new functionality.

Based 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 document states: "Appropriate product testing was performed to evaluate conformance to USP requirements, product specifications, and equivalence to the predicate design. The device was evaluated against individual functional and reliability requirements, as well as OverStitch Endoscopic Suturing System compatibility."

Specific quantitative acceptance criteria are not explicitly listed in this summary. Instead, it refers to conformance with USP requirements and product specifications.

The performance reported is qualitative: "The results of all studies confirmed substantial equivalence between the subject and predicate designs, and that no new issues of safety or efficacy were raised."

Performance Testing Mentioned:

• Bench testing included:
  • Needle passing reliability
  • Suture Cinch deployment and pull-off strength
  • Tensile strength per USP
  • Needle pull off strength per USP
  • Suture diameter measurements per USP
• Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F1929-15, ASTM DI69-16, and ASTM F1886/F1886M-16.
• Biocompatibility: Performed in accordance with ISO 10933-1, including extractable and leachable studies (ISO 10993-18: 2005) and toxicological risk assessment (ISO 10993-17: 2002).

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests are "bench testing" and "packaging integrity" studies, which implies laboratory-based, non-clinical data. No specific country of origin is mentioned, but the FDA approval implies compliance with US standards. This is retrospective in the sense that the testing was completed prior to submission.

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

• This information is not applicable as the evaluation relies on a comparison to a predicate device and bench testing against established standards (USP, ASTM, ISO), rather than a clinical study requiring expert assessment of patient outcomes or images for ground truth.

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

• Not applicable. As this is primarily bench testing and comparison to a predicate device, there is no need for an adjudication method as would be used in a clinical study with human readers or assessments where consensus is required.

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:

• No MRMC study was done. This device is a mechanical endosurgical suturing system, not an AI or imaging-based diagnostic tool. The concept of "human readers improving with AI assistance" is not relevant to this device. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

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

• Not applicable. This is a mechanical device, not an algorithm. Its performance is assessed through bench testing of its mechanical properties and functionality.

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

• The "ground truth" for this submission is established through conformance to recognized standards (USP, ASTM, ISO) and comparison to the performance characteristics of the legally marketed predicate device (K181141 - OverStitch™ Endoscopic Suturing System). It is not based on clinical "outcomes data" or "expert consensus" in the traditional sense of a diagnostic or therapeutic clinical trial. The phrase "no new issues of safety or efficacy were raised" implies the performance is deemed equivalent to the previously cleared device, which serves as a benchmark.

8. The sample size for the training set:

• Not applicable. This refers to a mechanical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable. See point 8.

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