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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 and Suture Cinch devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone and stainless steel materials.

The OverStitch ESS is designed for compatibility with dual channel endoscopes. The endcap of the Needle Driver Assembly attaches to the distal end of the endoscope, and the handle attaches to the proximal end. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary suture assembly with the Anchor Exchange to perform stitching operations.

The OverStitch Sx ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using silicone straps distributed along the length of the catheter and endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel. The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor assembly with the Anchor Exchange to perform stitching operations.

The OverStitch Helix is an optional device that is designed to acquire tissue by rotating the device handle into targeted area until tissue is gathered into the exposed helix coil. The acquired tissue is then pull into proximity of the needle body to complete the stitching operation.

The OverStitch Suture-Anchor Assembly is comprised of a 510(k) cleared suture product, manufactured from either polydioxanone or polypropylene materials attached to an implantable anchor manufactured from cobalt chrome and stainless steel. The Anchor component is intended to function with the OverStitch ESS device to perform stitching operations and serves as an anchor to secure suture placement, once released from the ESS.

The Overstitch Suture Cinch device is comprised of thermoplastic and stainless steel materials and includes an implantable PEEK Cinch component designed to secure the placement of suture as a final step of an OverStitch procedure. The device functions by squeezing the handle and deploying the PEEK components that press-fit onto the tail end of the suture to maintain suture position in situ.

The Apollo Endosurgery OverStitch Endoscopic Suturing System is a Class II medical device intended for endoscopic placement of suture(s) and approximation of soft tissue. The 510(k) summary provides information on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to its predicate device (K081853).

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. However, it states that "Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed system of devices was conducted in accordance with protocol. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility with various endoscopes."

The performance tests mentioned are:

The overall conclusion is that "The results of all studies confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised." This implies that the device met its defined performance specifications, which serve as the acceptance criteria for each test.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each performance test (e.g., number of needles tested, number of suture cinches). It indicates that "Appropriate product testing was performed on all subject devices."

The data provenance is retrospective, as the tests were conducted as part of a 510(k) submission to demonstrate substantial equivalence to an already marketed predicate device. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the document describes an evaluation of a physical medical device (suturing system) through engineering and bench testing, not an AI/software device that requires expert-established ground truth for image or data interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI evaluations where there might be disagreement among reviewers or interpreters.

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:

This information is not applicable. The device is a suturing system, not an AI or imaging diagnostic device that would involve human readers or AI assistance for interpretation.

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

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" refers to the established engineering specifications, physical measurements, and regulatory standards for device functionality, sterility, shelf-life, and biocompatibility.

• Bench Testing: Engineering specifications and physical measurements (e.g., strength measurements, deployment mechanisms).
• Sterility: Conformance to ISO 11135:2014.
• Shelf-Life: Functional and sterility testing results on aged products.
• Biocompatibility: Conformance to ISO 10933-1.

8. The Sample Size for the Training Set:

This information is not applicable as the document describes the evaluation of a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as point 8.

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