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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® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models of bacterial challenge following surgical implantation of the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.

AIGISRx® R is intended for single patient, one-time use only.

AIGISRx® R (AIGIS R) is a fully resorbable, dual component sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED), such as a pacemaker or an implantable cardioverter- defibrillator (ICD), when the electronic device is implanted in the body. AlGIS R is constructed of knitted filaments of a commercially available resorbable polymer, Glycoprene II, comprised of glycolide, caprolactone, trimethylene carbonate polymer, and coated with a bioresorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline in concentrations of 102 ug/cm.2

The AIGISRx® R (AIGIS R) is a medical device designed to securely hold and stabilize cardiovascular electronic implantable devices (CIEDs) like pacemakers or implantable cardioverter-defibrillators (ICDs) when implanted in the body. It is a fully resorbable, dual-component sterile prosthesis containing the antimicrobial agents rifampin and minocycline.

The device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a predicate device, the AIGISRx® (AIGIS) antibacterial envelope (K063091), rather than setting specific performance metrics for sensitivity, specificity, or similar outcome measures typically seen in AI/diagnostic device submissions. The core of the study is to prove that the new device, AIGIS R, performs similarly to the predicate device, despite a change in the surgical mesh substrate from non-resorbable polypropylene to bioresorbable Glycoprene II.

Here's a breakdown of the information based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary (a medical device rather than an AI/diagnostic software), the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity. Instead, they focus on equivalence to a predicate device regarding safety and efficacy aspects.

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

The summary does not explicitly state a "test set" in the context of clinical trials with human participant numbers for assessing diagnostic performance. The studies mentioned are primarily in vitro (bench testing) and in vivo (animal models, general biocompatibility, and AME).

• Sample Size: Not specified in terms of human subjects or a defined "test set" for a diagnostic/AI device. The in vivo studies likely refer to animal models, but specific numbers are not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal in vivo) conducted by the sponsor (TYRX, Inc., Monmouth Junction, NJ, USA). The studies are retrospective/prospective in the sense that they were conducted to support the 510(k) submission for this new device.

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

This section is not applicable for this type of medical device submission. Ground truth, in the context of diagnostic or AI devices, typically refers to expert interpretation of data or pathological findings. The assessment here is based on physical, chemical, and biological performance characteristics, verified by standard laboratory and in vivo animal testing, rather than human expert interpretation of a "test set" of images or patient data.

4. Adjudication Method for the Test Set

This is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations within diagnostic studies, which is not relevant here.

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

This is not applicable for this type of medical device submission. MRMC studies are used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a physical implantable medical device, not an AI or diagnostic software.

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

This is not applicable for this type of medical device submission. "Standalone performance" refers to the performance of an AI algorithm on its own. The AIGIS R is a physical implantable device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Bench Testing Results: Demonstrating material degradation, chemical structure integrity post-sterilization, and absence of interactions between components.
• ISO Standard Compliance: Adherence to ISO 10993 for biocompatibility and ISO 11137 for sterility.
• In vivo Model Results: Demonstrating antimicrobial effectiveness (AME) in an animal model of bacterial challenge and demonstrating that the device does not interfere with CIED function.

8. The Sample Size for the Training Set

This is not applicable. The AIGIS R is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the computational sense. The "training" or development of the device would involve materials science, engineering, and preclinical testing, not machine learning.

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

This is not applicable as there is no "training set" for an AI algorithm. For the development and testing of the physical device, the "ground truth" (i.e., the desired properties and performance) was established through:

• Regulatory Standards: Compliance with ISO standards for biocompatibility and sterility.
• Predicate Device Performance: Benchmarks set by the established safety and efficacy profile of the AIGISRx® (K063091) predicate device.
• Scientific and Engineering Principles: Underlying principles for material science, chemical stability, and antimicrobial efficacy testing.

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