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AIGISRx is intended to securely hold a pacemaker pulse generator or defibrillator in order to create a stable environment when implanted in the body. AIGISRX 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 the generator or defibrillator. This device is only intended to be used in conjunction with pacemakers and implantable defibrillators.

AIGISRX is a dual component (resorbable and non-resorbable), sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. AIGISRX is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer. AIGISRX bioresorbable polymer coating contains the antimicrobial agents, rifampin and minocycline in concentrations of 86 ug/cm2.

Here's an analysis of the provided text regarding the AIGISRX™ Anti-bacterial Envelope, focusing on acceptance criteria and the supporting study information:

It's important to note that the provided text is a 510(k) summary and not a comprehensive study report. Therefore, some information, particularly detailed methodological aspects typically found in full study publications, is either summarized or not explicitly stated.

Acceptance Criteria and Device Performance for AIGISRX™ Anti-bacterial Envelope

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list formal "acceptance criteria" in the manner of specific pre-defined thresholds for performance metrics (e.g., "sensitivity must be > 90%"). Instead, the document outlines the device's intended functions and then presents performance data demonstrating that these functions are met, thereby supporting its substantial equivalence to predicate devices.

Here's an interpretation of the implicit "acceptance criteria" based on the device's intended use and the reported performance:

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

• Test Set Description: The "test set" for the in vivo efficacy was described as "a series of studies in which a pulse generator canister placed into a AIGISRX™ pouch and generator canister alone (Control) were implanted into appropriate models of infectivity (dogs or rabbits)."
• Sample Size: The exact number of animals (dogs or rabbits) used in these in vivo studies is not specified in the provided text.
• Data Provenance: The in vivo data was obtained from animal models (dogs or rabbits). The country of origin is not specified. The studies appear to be prospective experimental studies designed to test the device's efficacy. The in vitro studies were laboratory-based experiments.

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

This information is not applicable and not provided in the context of this device and studies. The studies described are in vitro antimicrobial tests and in vivo animal infection models. "Ground truth" in these cases would be established by direct observation of microbial growth (in vitro) or clinical signs of infection, bacterial cultures, and potentially histological analysis (in vivo animal models), rather than expert reader interpretations of medical images.

4. Adjudication method for the test set

This information is not applicable and not provided. Given the nature of microbiology and animal model studies, adjudication methods (like 2+1 or 3+1 consensus) are typically used for human retrospective image analysis or clinical endpoint determination from human trials, not for direct laboratory or animal observations.

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

This information is not applicable. The AIGISRX™ Anti-bacterial Envelope is a physical medical device (an implantable envelope with antimicrobial agents), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this product.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• In Vitro Studies: The ground truth for antimicrobial activity was established by direct observation of microbial growth or inhibition in laboratory settings using various bacterial strains.
• In Vivo Studies (Animal Models): The ground truth for infection presence/absence was established by direct evidence of infection in the animal models. This likely involved:
  • Bacterial inoculation: Directly infecting the implanted control and device groups.
  • Clinical observation: Monitoring animals for signs of infection.
  • Microbial culture: Culturing implant sites or tissues from the animals to validate the presence and identify the bacteria causing infection.
  • The statement "observed for a minimum of 7 days to validate the presence of infection in the animals" suggests a direct endpoint.

8. The sample size for the training set

This information is not applicable in the context of this device. A "training set" typically refers to data used to train a machine learning algorithm. Since this is a physical medical device, there is no algorithm to train. The preclinical in vitro and in vivo studies are direct performance evaluations, not training phases for an algorithm.

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

This information is not applicable, as there is no "training set" in the sense of data used for machine learning.

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