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The envelope is intended to hold a pacemaker pulse generator or defibrillator securely in order to provide a stable environment when implanted in the body. The envelope 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. The envelope is intended to be used in conjunction with pacemakers and implantable defibrillators.

TYRXTM Absorbable Antibacterial Envelope (TYRX Envelope, or the envelope) is a sterile prosthesis comprised of two components; an absorbable substrate mesh, and an absorbable tyrosine based polyarylate polymer containing the antimicrobial agents, rifampin and minocycline, and is designed to hold a Cardiovascular Implantable Electronic Devices. CIED. (pacemaker or Implantable Cardioverter Defibrillator, ICD), securely to create a stable environment when the device is implanted in the body.

The TYRX Envelope is constructed of multifilament knitted mesh composed of glycolide, caprolactone, and trimethylene carbonate polymer, which is coated with an absorbable polyarylate polymer containing the drug substances rifampin and minocycline.

Like its predicate, the TYRX Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. pacemaker size (Medium), and a 2.9 in. x 3.3 in. ICD size (Large).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

This submission is for a shelf-life extension of an existing device, the TYRX Absorbable Antibacterial Envelope. Therefore, the "acceptance criteria" and "device performance" primarily revolve around the device's stability over an extended period.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The text does not explicitly state the numerical sample size used for the stability study itself (e.g., number of envelopes tested, or individual data points). It refers to "stability study data collected."
• Data Provenance: The data was gathered from a "stability study" conducted by Medtronic, Inc. It can be inferred as prospective given it's a stability study to support a shelf-life extension. There is no information about the country of origin of the data provided in this document.

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 to this submission. The "ground truth" for a shelf-life extension study is typically established by predetermined specifications and analytical methods for the product's physical, chemical, and functional properties, not by expert consensus or interpretations in the way one might evaluate diagnostic images or clinical outcomes. The device's performance is measured against these established specifications.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for consensus-building among human reviewers, typically for clinical endpoints or image interpretation. For a stability study, the assessment is based on analytical test results against predefined specifications.

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. This submission is for a medical device (surgical mesh with antimicrobial agents), not an AI/imaging diagnostic device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or reported here.

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

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

7. The type of ground truth used:

The ground truth used for this shelf-life extension study is established product specifications and analytical test methodologies. The device's performance (e.g., drug content, mechanical integrity, sterility if applicable, and other "all product requirements") is measured directly against these predefined quantitative and qualitative standards.

8. The sample size for the training set:

This information is not applicable. This is not an AI/machine learning product that requires a "training set."

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

This information is not applicable as it's not an AI/machine learning product.

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The absorbable antibacterial envelope is intended to hold a pacemaker or defibrillator securely in order to provide a stable environment when implanted in the body. The absorbable antibacterial envelope 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.

TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) is a sterile prosthesis comprised of two components; an absorbable substrate mesh, and a resorbable tyrosine based polyarylate polymer containing the antimicrobial agents, rifampin and minocvcline, and is designed to hold a Cardiovascular Implantable Electronic Devices, CIED, (pacemaker or Implantable Cardioverter Defibrillator, ICD), securely to create a stable environment when the device is implanted in the body.

The TYRX Envelope is constructed of knitted filaments of Glycoprene II, a polymer composed of glycolide, caprolactone, and trimethylene carbonate polymer, which are coated with a bioresorbable polyarylate polymer containing the drug substances rifampin and minocycline.

Like its predicate device (originally named, AIGISax R), the TRYX Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. pacemaker size (Medium), and a 2.9 in. x 3.3 in. ICD size (Large).

The provided text is a 510(k) summary for the Medtronic TYRX Absorbable Antibacterial Envelope. This document focuses on demonstrating substantial equivalence to a predicate device for a shelf-life extension and modified packaging, not on proving the initial efficacy or safety of the device itself. Therefore, much of the information typically found in acceptance criteria and study descriptions for new medical devices (e.g., diagnostic performance metrics, human reader studies, ground truth establishment) is not present.

However, I can extract the relevant information regarding the changes and how they meet acceptance criteria.

1. Table of acceptance criteria and the reported device performance

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

The document does not specify a distinct "test set" in the way one would for diagnostic or therapeutic efficacy studies. The testing described is primarily related to packaging validation and stability testing.

• Stability Studies: The stability study data was collected per ICH guidelines. The sample size for this study is not explicitly stated but would have included multiple units of both the medium and large TYRX Envelope sizes in the modified packaging over the proposed shelf life. The provenance is not specified, but it would presumably be from Medtronic's internal testing facilities.
• Packaging Validation: The document states "modified packaging has been validated for use." Specific sample sizes for this validation (e.g., sterility testing, peel strength testing) are not provided.

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 to this 510(k) submission. "Ground truth" in the context of expert consensus is typically used for evaluating diagnostic accuracy or clinical outcomes, which are not the subject of this submission. The "ground truth" here is adherence to engineering specifications and stability requirements.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations, which is not relevant for packaging and shelf-life studies.

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 not an AI-assisted diagnostic tool, and no MRMC study was performed or is relevant to this submission.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission consists of:

• Pre-defined engineering specifications for the device (e.g., material composition, peel strength, sterility assurance level, physical dimensions, drug content).
• ICH guidelines for stability testing, which define acceptable parameters for product degradation over time.

8. The sample size for the training set

Not applicable. There is no training set in the context of machine learning for this device.

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

Not applicable. There is no training set. The "ground truth" (specifications and guidelines) is established by internal product development, regulatory standards, and industry best practices.

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