(198 days)
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.
| 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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.