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

The Apollo Endosurgery OverStitch Endoscopic Suture System provides physicians the ability to perform several different types of tissue apposition within the Gastrointestinal (GI) Tract and peritoneal cavity. Additionally, the system allows the surgeon to 'reload' the suture without the need for removing the endoscope.

The provided text is for a 510(k) summary for the Apollo Endosurgery OverStitch Endoscopic Suture System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria or the specific study data typically found in a clinical performance study report.

Based on the provided text, here is what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document only mentions "Suture placement and securement testing was performed by comparing the OverStitch to commercially available predicate products." without detailing the number of tests performed or any sample size justification.
• Data Provenance: Not specified. It's unclear if this testing was done with ex-vivo, in-vivo, or simulated models, or in which facility/country the testing occurred. Given it's a 510(k) summary, it's highly likely to be internal engineering/bench testing rather than clinical data from human subjects.

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

• This information is not provided. The testing described appears to be technical/mechanical performance comparisons rather than expert-driven clinical evaluations.

4. Adjudication method for the test set

• This information is not provided. As the testing is described as mechanical and comparative, an adjudication method in the context of clinical ground truth would not typically apply.

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, an MRMC comparative effectiveness study was NOT done. This device is an endoscopic suturing system, a medical device for performing surgical tasks, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI" is not applicable here.

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.

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

• For the "Suture placement and securement testing," the ground truth was effectively defined by the performance of the predicate devices. The OverStitch was deemed "equivalent" if its performance matched or was within an acceptable range of the predicate devices for suture placement and securement. No independent clinical "ground truth" (e.g., pathology, long-term outcomes) is mentioned for this specific testing. For the other mechanical tests, the ground truth would be the pre-defined product specifications.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable. This is a mechanical device, not an AI/machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes "Product testing was conducted to evaluate conformance to product specification." This included:

• Mechanical strength testing
• Bond strength
• Suture operation
• Suture securement
• Visual / dimensional inspection

Additionally, a comparative study was performed:

• Study Type: Comparative bench testing.
• Comparison: OverStitch was compared against "commercially available predicate products" (K061770 Endoscopic Suturing System (ESS) - Ethicon Endo Surgery, K003956 EndoCinch Suturing System - Davol / Bard, K972911 Auto Suture-Endo Stitch - Tyco Healthcare).
• Methodology: The devices were used "per their respective Instructions for Use."
• Outcome: The results "showed the OverStitch was equivalent to the predicate devices" in terms of suture placement and securement.

This submission is a 510(k) for substantial equivalence. The "study" described is primarily bench testing to demonstrate that the new device performs comparably to already cleared predicate devices and meets its own product specifications. This type of submission relies on the concept that if a new device is substantially equivalent to a legally marketed predicate device, it can be marketed without requiring new clinical trials, as the predicate's safety and effectiveness have already been established.

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