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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
All product requirements (e.g., chemical stability of drugs, structural integrity of mesh, mechanical properties) met for proposed shelf-life.	Device continues to meet all product requirements through the proposed shelf life.

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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K Number

K180122

Device Name

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

Manufacturer

Medtronic, Inc.

Date Cleared

2018-06-07

(142 days)

Product Code

FTL

Regulation Number

878.3300

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K150291

Predicate For

K192636

Intended Use

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.

Device Description

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).

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria / Performance Requirement (Implied/Stated)	Reported Device Performance / Study Finding
Shelf Life	Continued to meet all product requirements through the proposed extended shelf life.	"Results of this study demonstrate the TYRX Neuro Envelope, both medium and large size, in modified foil pouch packaging continue to meet all product requirements through the proposed shelf life." The document states "stabilty study data collected per ICH guidelines" supports this claim. The exact duration of the extended shelf life is not explicitly stated in the provided text, but it is implied to be longer than the predicate device's shelf life.
Packaging Integrity	Modified packaging validated for use and demonstrated to meet the same sterility assurance level as the current package.	"The modified foil pouch packaging is constructed of similar materials (layered polyethylene and foil) and the foil pouch peel strength is the same as the current package."
"The modified packaging has been validated for use and demonstrated to meet the same sterility assurance level as the currently marketed package."
Drug Component Stability	Stability of antimicrobial agents (rifampin and minocycline) throughout the extended shelf life.	Implied by "continue to meet all product requirements through the proposed shelf life." The product specifications, including drug content, must remain within defined limits.
Sterility	Maintenance of sterility assurance level within proposed shelf life.	"The modified packaging has been validated for use and demonstrated to meet the same sterility assurance level as the currently marketed package." Implied that this sterility is maintained for the extended shelf life.
Functional Performance	Ability to securely hold a nerve stimulator and create a stable environment.	"Overall, these modifications do not affect the intended use of the device or alter the fundamental scientific technology." and "There are no changes to the physical design, principles of operation, or mechanism of action of the current TYRX Neuro Envelope." The original function of the envelope is assumed to be maintained because the physical structure and materials (apart from packaging) are unchanged.