(206 days)
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
| Acceptance Criteria (What the device must continue to meet) | Reported Device Performance (Summary of study results) |
|---|---|
| All product requirements through the proposed shelf life | "Results of this study demonstrate the TYRX Envelope, both medium and large size, continue to meet all product requirements through the proposed shelf life." |
| Same finished goods acceptance criteria (as currently marketed device) | "The modified device meets the same finished goods acceptance criteria, using the same analytical test methodologies, as the currently marketed device." |
| No change to design, materials, mechanism of action, patient contact, intended use, or risk profile. | "The extended shelf life TYRX Envelope design, materials, mechanism of action, patient contact and intended use are the same as the predicate device." |
| "The individual and cumulative impact of these changes does not alter the risk profile of the TYRX Envelopes." |
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.
§ 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.