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AIGISRx N is intended to hold a vagus nerve stimulator or spinal cord neuromodulator 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. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or spinal cord neuromodulators implanted laterally to the body midline and slightly superior to the qluteal region.

AIGISRs N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator or spinal cord neuromodulator 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. Rifampin and minocycline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device.

This document describes the AIGISRx N Antibacterial Envelope, a surgical mesh designed to secure nerve stimulators. The submission is a 510(k) for an expanded indication for use to include spinal cord neuromodulators (SCNM).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, focusing on the expanded indication:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The core physical, chemical, and mechanical properties (mesh knit characteristics, suture retention strength, burst strength) are stated to be identical to the predicate device (K131007), implying they meet prior acceptance criteria for those aspects, though specific values are not provided in this document.

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

• Expanded Indication Study for Minocycline/Rifampin Diffusion and CNS Effects:
  • Sample Size: 8 sheep (2 sheep per treatment group across 4 groups).
  • Data Provenance: Prospective, animal (sheep) model data. The country of origin is not specified but it's an in vivo model.

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

• For the expanded indication study (minocycline/rifampin diffusion and safety in SCNM model), the "ground truth" would be the direct measurement of drug concentrations in plasma and CSF, and observation of clinical signs. This does not typically involve human expert adjudication in the same way image analysis or diagnostic studies do.
• The assessment of "absence of adverse clinical signs" would likely be performed by veterinary professionals or study personnel trained in animal welfare and observation. Their specific qualifications are not detailed in the document.

4. Adjudication Method for the Test Set

• For the expanded indication study, an adjudication method (like 2+1, 3+1) is not applicable. The outcome measures (drug concentrations, clinical signs) are objective measurements or direct observations rather than subjective interpretations requiring multiple expert reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic algorithms (e.g., in radiology) to assess whether AI assistance improves human reader performance. The AIGISRx N is a physical medical device (surgical mesh), not a diagnostic algorithm, so this type of study is not relevant to its evaluation.

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

• Not applicable. The AIGISRx N Antibacterial Envelope is a physical medical device, not an algorithm. Its performance is assessed directly through bench testing and in vivo studies, not as an algorithm's standalone performance.

7. The Type of Ground Truth Used

• For the expanded indication study, the ground truth was based on:
  • Direct Analytical Measurement: Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid (CSF) samples.
  • Direct Observation/Clinical Assessment: Absence of adverse clinical signs in the sheep model.

8. The Sample Size for the Training Set

• Not applicable. As the device is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The studies mentioned (biocompatibility, sterility, functionality, and the sheep model) are performance and safety validation studies.

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

• Not applicable, as there is no training set for this type of device.

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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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