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The envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body.

The envelope contains the antimicrobial agents, rifampin and minocycline, which have been shown 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 or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.

TYRX™ Neuro Absorbable Antibacterial Envelope (TYRX Neuro 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 vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator, or a sacral nerve stimulator securely to create a stable environment when the device is implanted in the body.

The TYRX Neuro 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 device, the TRYX Neuro Envelope is supplied in two sizes, a 2.5 in. x 2.7 in. (Medium), and a 2.9 in. x 3.3 in. (Large). The appropriate size should be selected based on the external dimensions of the vagus nerve stimulator, the spinal cord neuromodulator, the deep brain stimulator, or the sacral neuro stimulator that is to be implanted.

This document is a 510(k) summary for the TYRX Neuro Absorbable Antibacterial Envelope, seeking an extension of its shelf life. The submission does not involve changes to the device's design, materials, or intended use, but rather demonstrates its continued performance over a longer period.

Based on the provided text, the device itself (TYRX Neuro Absorbable Antibacterial Envelope) is not an AI/ML powered medical device. It is a physical medical device designed to hold nerve stimulators and contains antimicrobial agents. Therefore, many of the requested criteria related to AI/ML device performance (like multi-reader multi-case studies, effect size of human improvement with AI, standalone performance, ground truth for training sets, etc.) are not applicable to this submission.

However, I can extract information related to the acceptance criteria for the shelf-life extension and the study supporting it.

1. A table of acceptance criteria and the reported device performance

The document states: "Results of this study demonstrate the TYRX Neuro Envelope, both medium and large size, continue to meet all product requirements through the proposed shelf life." And "The modified device meets the same finished goods acceptance criteria, using the same analytical test methodologies, as the currently marketed device."

While specific numerical acceptance criteria are not explicitly listed in this summary, the core acceptance criterion is that the device continues to meet all product requirements throughout the extended shelf life. This implies that critical performance parameters (e.g., integrity of the absorbable mesh, stability and release profile of the antimicrobial agents, mechanical properties to securely hold the stimulator) remain within their pre-defined specifications.

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

The document mentions "stability study data collected per ICH guidelines." ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines typically require specific numbers of lots and time points for stability studies. However, the specific sample size (number of envelopes tested) is not detailed in this 510(k) summary.

Regarding data provenance: The study was conducted by Medtronic, Inc. for products intended for the U.S. market. The study design (stability study) is inherently prospective with respect to the shelf life assessment.

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

This question is not applicable as the submission relates to a physical device's shelf-life stability, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for interpretation of images or clinical data. Device performance is assessed through analytical testing.

4. Adjudication method for the test set

This question is not applicable for the same reasons as point 3.

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 question is not applicable as the device is a physical medical implant, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as the device is a physical medical implant, not an algorithm.

7. The type of ground truth used

For this shelf-life extension, the "ground truth" is established by the pre-defined quality specifications and performance requirements for the TYRX Neuro Absorbable Antibacterial Envelope. The stability study aims to demonstrate that the device continues to meet these specifications over the extended shelf life, using analytical methods.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical device's shelf-life stability testing.

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

This question is not applicable as there is no "training set" for this type of submission.

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TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body.

TYRX Neuro 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.

TYRX™ Neuro Absorbable Antibacterial Envelope (TYRX Neuro 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 minocycline, and is designed to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator, or a sacral nerve stimulator securely to create a stable environment when the device is implanted in the body.

The TYRX Neuro 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 , the TRYX Neuro 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).

This document is a 510(k) summary for a medical device (TYRX Neuro Absorbable Antibacterial Envelope). It focuses on demonstrating substantial equivalence to a predicate device, primarily due to changes in packaging and an extended shelf life.

It does not describe a study that involves software with acceptance criteria and device performance in the way typically associated with diagnostic or AI/ML devices. Therefore, a table of acceptance criteria and device performance, as well as several other requested points (sample sizes, expert qualifications, MRMC studies, standalone performance, training set details), are not applicable to this type of submission.

The core of this submission is about physical device stability and packaging integrity rather than the performance of a diagnostic or AI algorithm.

However, I can extract the relevant information that is present in the document regarding the "study" that proves the device meets its core claims (which, in this context, relate to shelf life).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The stability study would have involved a number of manufactured units of the device.
• Data Provenance: Not specified, but implied to be internal testing conducted by Medtronic, Inc. This is a technical (benchtop/laboratory) study, not a clinical study involving patient data. This would be prospective data collection, specifically designed to test the extended shelf life.

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

• Not Applicable. This submission does not involve expert review or "ground truth" establishment in the context of diagnostic performance. The "ground truth" for shelf life testing is determined by laboratory measurements against predefined product specifications.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of results is described, as this is a technical/engineering study for shelf life.

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 is not an AI/ML or diagnostic device.

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

• Not Applicable. This is not an AI/ML or algorithm-based device.

7. The type of ground truth used

• For the shelf-life extension: Product Specifications. The "ground truth" is that samples tested at various time points during the stability study must continue to meet established finished product specifications for properties like drug content, sterility, physical integrity (e.g., peel strength), etc.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML or algorithm-based device that undergoes a "training" process.

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

• Not Applicable.

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TYRX Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body.

TYRX Neuro 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 a pulse generator. This device is intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region.

TYRX Neuro Absorbable Antiqacterial Envelope is intended for single patient, one-time use only.

TYRX 110 Neuro Absorbable Antibacterial Envelope is a fully absorbable, dual component sterile device designed to hold a vagus nerve stimulator (VNS), a deep brain stimulator (DBS), a spinal cord neuromodulator (SCN) or a sacral nerve stimulator (SNS) securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline. Rifampin and minocvcline have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of an implantable electronic device. This device is to be used in a healthcare facility/hospital by qualified personnel experienced in the procedure of VNS, DBS, SCN, or SNS implantation.

This document is a 510(k) summary for the TYRX Neuro Absorbable Antibacterial Envelope. It describes the device and its indications for use, and argues for its substantial equivalence to a predicate device (K142611).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies, based on the specific questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it describes various studies and results to demonstrate safety and effectiveness for its expanded indications for use. The overall acceptance criterion is demonstrating substantial equivalence to the predicate device.

Here's a summary of the performance claims based on the provided text, linked to the implicit acceptance criteria for establishing substantial equivalence:

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

• Animal Study (for expanded indications):

  • Sample Size: 8 sheep (2 sheep per treatment group across 4 treatment groups).
  • Data Provenance: Not explicitly stated, but animal studies are typically prospective. No country of origin is mentioned.

• In vitro and In vivo efficacy testing (referenced from predicate K142611):

  • Sample Size: Not specified in this document, as these studies belong to the predicate device.
  • Data Provenance: Not specified.

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)

This device is a physical medical device (an absorbable antibacterial envelope), not an AI/imaging device requiring expert interpretation for ground truth establishment in the traditional sense. The "ground truth" here relates to objective measures like drug concentrations (in the animal study), microbial inhibition (in vitro), and infection rates (in vivo), or material properties. Therefore, there are no explicitly mentioned "experts" establishing ground truth in the way described for diagnostic AI.

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

Not applicable. As this is not an AI/imaging device with human reader evaluations, there is no adjudication method for a test set of interpretations.

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 is not a diagnostic AI device, so no MRMC study involving human readers and AI assistance was conducted or described.

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

Not applicable. This is not an algorithm or software device. The product is a physical medical device.

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

• Animal Study: Ground truth was based on objective measurements:
  • Absence of adverse clinical signs (clinical observation).
  • Quantifiable concentrations of minocycline and rifampin in plasma and cerebrospinal fluid samples (laboratory analysis).
• In vitro studies (referenced from predicate K142611): Ground truth would be based on laboratory methods for demonstrating antimicrobial activity (e.g., zones of inhibition, minimum inhibitory concentrations).
• In vivo studies (referenced from predicate K142611): Ground truth would be based on outcomes data related to infection rates/reduction in animal models.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of AI development. The studies performed are for device safety and efficacy, not for training a model.

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

Not applicable, as there is no training set.

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TYRX™ Neuro Absorbable Antibacterial Envelope 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.

TYRX™ Neuro 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 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 gluteal region.

TYRX™ Neuro Absorbable Antibacterial Envelope is intended for single patient, one-time use only.

TYRX ™ Neuro Absorbable Antibacterial Envelope is a fully absorbable , dual component sterile device 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 a commercially available absorbable polymer, Glycoprene II, comprised of glycolide, caprolactone and trimethylene carbonate polymer, and coated with an absorbable polyarylate polymer mixture 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 is to be used in a healthcare facility/hospital by personnel experienced in the procedure of vagus nerve or spinal cord neuromodulator implantation.

This document describes a 510(k) premarket notification for the TYRX™ Neuro Absorbable Antibacterial Envelope. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets new acceptance criteria through a dedicated study with specific performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted directly from this document. The document primarily details comparative information with predicate devices and safety testing.

Here's an analysis of the provided information based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria (e.g., a certain percentage reduction in infection rate, a specific tensile strength at a given time point) that the new device was tested against in its own clinical study. Instead, it relies on demonstrating equivalence to predicate devices, which were previously cleared.

However, it does mention results from in vitro and in vivo studies that support the predicate devices' antimicrobial activity, which is a key performance aspect.

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

• Test Set Sample Size: Not explicitly stated for any new clinical test set for the subject device. The document refers to "in vitro studies" and "in vivo efficacy testing" performed on the predicate devices. The sample sizes for these predicate studies are not provided in this document.
• Data Provenance: The "in vivo efficacy testing" was "previously submitted with the primary predicate, K132699" and "previously submitted with predicate K130943." This implies the data is likely retrospective relative to this 510(k) submission, as it comes from prior submissions. The country of origin is not specified, but given the FDA submission, it would adhere to US regulatory standards.

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

This information is not provided. The document highlights laboratory (in vitro), animal (in vivo), and bench testing, not studies requiring human expert adjudication of clinical outcomes in the same way a diagnostic imaging device might.

4. Adjudication Method for the Test Set

Not applicable for the types of tests described (in vitro, in vivo efficacy in animals, bench testing).

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 a medical implant (envelope for neuromodulators) containing antibiotics, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable, as this is not an algorithm. However, the in vitro and in vivo animal efficacy studies can be considered standalone performance assessments of the antimicrobial properties and safety profile.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For antimicrobial activity (in vitro): Direct observation of bacterial inhibition/killing.
• For in vivo efficacy (animal studies): Likely based on direct measurement of infection rates or bacterial counts at the surgical site in animal models, comparing treated groups to control groups. This would be considered "outcomes data" in an animal model.
• For biocompatibility: Standardized toxicological and immunological endpoints as per ISO 10993.
• For degradation and interaction: Bench testing and chemical analysis.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

Not applicable. This device does not involve machine learning or AI that requires a "training set."

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