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AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N contains the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.

AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline.

The provided text describes the AIGISRx® N, a surgical mesh device, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the specific details requested in your prompt related to AI/algorithm performance.

The document is a 510(k) summary for a medical device (surgical mesh), which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It discusses the device's physical, chemical, and mechanical properties, biocompatibility, sterility, and intended use.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria & Reported Performance (Table): The document states that the new device has the "same" characteristics as the predicate device (mesh knit, suture retention, tear, burst strength) and that "bench testing shows that gamma sterilization has no detrimental effect." It also mentions "Standard ISO 10993 testing demonstrated the biocompatibility and safety of the device." However, specific numerical acceptance criteria (e.g., minimum burst strength, maximum allowed bacterial growth) and the exact performance results against those criteria are not provided.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for a study): The document refers to an "in vivo functionality study showed that AIGIS devices do not alter or interfere with an implantable pacemaker or defibrillator" and an "in vivo model of bacterial challenge" for the antimicrobial agents. However, these are mentioned broadly to support the device's characteristics or an active ingredient's effect, not as a detailed study report with the specific elements you're asking for (test set size, ground truth establishment, expert involvement, etc.). There is no mention of an algorithm or AI in this document, therefore, details related to AI performance studies are absent.
• Training Set Sample Size & Ground Truth: Since no AI/algorithm study is detailed, there's no information about a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (surgical mesh), not on evaluating the performance of an AI/algorithm. Therefore, the specific details you requested regarding acceptance criteria, study methodologies, and AI performance are not available in this document.

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PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation.

PIVIT A/BTM ST is intended for single patient one-time use only.

PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference.

PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents, rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.

The provided text describes a 510(k) summary for a medical device called PIVIT A/B ST, which is a polymeric surgical mesh. The document focuses on establishing substantial equivalence to previously cleared predicate devices rather than detailing a specific performance study with acceptance criteria and results.

Therefore, many of the requested sections about acceptance criteria, performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Cannot be extracted. The document states "Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656." It does not provide specific acceptance criteria or performance results for PIVIT A/B ST in this document. The basis for clearance is substantial equivalence to predicates, not specific performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be extracted. No new performance study or test set is described for PIVIT A/B ST. The clearance is based on equivalence to predicate devices.

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):

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

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:

• Cannot be extracted. This device is a surgical mesh, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable.

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

• Cannot be extracted. This device is a physical surgical mesh, not an algorithm, so this question is not applicable.

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

• Cannot be extracted. This information is relevant to performance studies, which are not detailed in this 510(k) summary for PIVIT A/B ST.

8. The sample size for the training set:

• Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm requiring a training set.

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

• Cannot be extracted. This device is a physical surgical mesh, not an AI/ML algorithm.

Summary of what is known:

• Device Name: PIVIT A/B ST (Polymeric Surgical Mesh)
• Intended Use: As a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue, including hernias and/or body wall defects. The resorbable polymer coating also contains antimicrobial agents (rifampin and minocycline) to help protect from microbial colonization.
• Basis for Clearance: Substantial equivalence to predicate devices (PIVIT A/B (K053656), Strattice (K070560), HydroCoat Mesh (K090271)).
• Performance Data: Provided by reference to the previously cleared PIVIT A/B device (K053656). This summary introduces a line extension for PIVIT A/B ST, stating it is "identical to the PIVIT A/B device cleared via K053656."

In conclusion, this 510(k) summary does not contain the detailed performance study information with acceptance criteria, sample sizes, and ground truth establishment that you are requesting. Its purpose is to demonstrate substantial equivalence to existing devices for a medical device that is a physical implant, not a diagnostic or AI-driven system.

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