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neoClose is intended to facilitate the delivery of absorbable AutoAnchors through soft tissues of the body during endoscopic/laparoscopic surgery.

The neoClose AutoAnchor Pack consists of absorbable AutoAnchors and neoClose Drivers. The neoClose AutoAnchor consists of an absorbable suture attached to an absorbable polymeric anchor. There are two distinct product codes: the neoClose 2 AutoAnchor Pack (NCAA2-U) and the neoClose 4 AutoAnchor Pack (NCAA4-U). The neoClose AutoAnchors and Drivers are provided sterile (EtO). Each neoClose AutoAnchor is pre-loaded on a neoClose Driver. The neoClose Driver is used to deliver an AutoAnchor through the abdominal wall layers into the abdominal cavity for subsequent soft tissue approximation. The neoClose AutoAnchor and Driver are to be used in conjunction with a neoClose Guide.

This document (K142903) is a 510(k) premarket notification for the neoClose AutoAnchor Pack. It establishes substantial equivalence to previous neoClose devices. The document does not contain the detailed study information requested. It states that "Performance Data" was provided, but only lists "Biocompatibility" and "Bench Testing" at a high level, without any specific acceptance criteria, reported performance, sample sizes, ground truth details, or information about human reader studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document states: "Bench Testing was conducted for the neoClose AutoAnchor Pack to demonstrate that it is at least as safe and effective as the predicate device." However, no specific acceptance criteria or reported device performance metrics are provided in this document.

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

Not provided in this document. The document only mentions "Bench Testing" was conducted.

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

Not applicable/Not provided. The document does not describe studies involving expert interpretation or ground truth establishment for a test set.

4. Adjudication method for the test set

Not applicable/Not provided.

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 device is a surgical instrument (suture passer), not an AI-powered diagnostic or interpretive device.

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

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

7. The type of ground truth used

Not applicable/Not provided. The document refers to "Bench Testing" and "Biocompatibility" without specifying a ground truth in the context of diagnostic performance.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable/Not provided. This device is not an AI/ML algorithm.

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