(46 days)
AIGISRx® R is intended to hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment when implanted in the body. AIGISRx R contains the antimicrobial agents rifampin and minocycline which have been shown to reduce infection in in vivo models 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.
AIGISRx® R is intended for single patient, one-time use only.
AIGISRx® R (AIGIS R) is a fully resorbable, dual component sterile prosthesis designed to hold and stabilize a cardiovascular electronic implantable device (CIED), such as a pacemaker or an implantable cardioverter- defibrillator (ICD), when the electronic device is implanted in the body. AlGIS R is constructed of knitted filaments of a commercially available resorbable polymer, Glycoprene II, comprised of glycolide, caprolactone, trimethylene carbonate polymer, and coated with a bioresorbable polyarylate polymer mixture containing the antimicrobial agents rifampin and minocycline in concentrations of 102 ug/cm.2
The AIGISRx® R (AIGIS R) is a medical device designed to securely hold and stabilize cardiovascular electronic implantable devices (CIEDs) like pacemakers or implantable cardioverter-defibrillators (ICDs) when implanted in the body. It is a fully resorbable, dual-component sterile prosthesis containing the antimicrobial agents rifampin and minocycline.
The device's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to a predicate device, the AIGISRx® (AIGIS) antibacterial envelope (K063091), rather than setting specific performance metrics for sensitivity, specificity, or similar outcome measures typically seen in AI/diagnostic device submissions. The core of the study is to prove that the new device, AIGIS R, performs similarly to the predicate device, despite a change in the surgical mesh substrate from non-resorbable polypropylene to bioresorbable Glycoprene II.
Here's a breakdown of the information based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary (a medical device rather than an AI/diagnostic software), the acceptance criteria are not in terms of traditional metrics like sensitivity/specificity. Instead, they focus on equivalence to a predicate device regarding safety and efficacy aspects.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (AIGIS R) |
|---|---|---|
| Material Composition Equivalence | The resorbable mesh (Glycoprene II) and its interaction with other components (polyarylate coating, antibiotics) should be safe and functionally equivalent to the predicate's non-resorbable mesh regarding degradation and chemical properties. | Bench testing demonstrated that AIGIS R degrades into its constituent monomers without chemical or physical interaction between the Glycoprene mesh, polyarylate coating, or antibiotics. Also, gamma sterilization has no effect on the chemical structure or thermal properties of Glycoprene II mesh. |
| Antimicrobial Effectiveness (AME) Equivalence | The AME of AIGIS R should be equivalent to that of the predicate device (AIGIS), demonstrating similar infection reduction capabilities. | Anti-microbial effectiveness (AME) studies (both in vivo and in vitro) demonstrated that the AME of AIGIS R is equivalent to AIGIS. |
| Biocompatibility & Safety | The device must be biocompatible and safe according to established standards. | Testing, according to ISO Standard 10993, demonstrated the biocompatibility and safety of the device. All forms of the AIGISRx family of devices are supplied sterile, biocompatible, and nonpyrogenic, following ISO 11137 for sterility. |
| Functional Equivalence | The device should not interfere with the functioning of the implantable cardiovascular electronic device and should securely hold the CIED. | In vivo studies demonstrated that the AIGIS R device does not interfere with the functioning of the implantable cardiovascular electronic device. The device is designed to "hold a pacemaker pulse generator or defibrillator securely in order to create a stable environment." |
| Drug Content Equivalence (Label Claim) | The drug content (rifampin and minocycline) for AIGIS R should be within acceptable ranges, comparable to the predicate device’s established efficacy. | AIGIS R PM size: Rifampin - 8.0 mg, Minocycline - 5.1 mg. |
| AIGIS R ICD size: Rifampin - 11.9 mg, Minocycline - 7.6 mg. | ||
| (Predicate AIGIS: up to 11 mg each for PM size, up to 16 mg each for ICD size. The new values are specified, implying they are deemed acceptable for efficacy.) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not explicitly state a "test set" in the context of clinical trials with human participant numbers for assessing diagnostic performance. The studies mentioned are primarily in vitro (bench testing) and in vivo (animal models, general biocompatibility, and AME).
- Sample Size: Not specified in terms of human subjects or a defined "test set" for a diagnostic/AI device. The in vivo studies likely refer to animal models, but specific numbers are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal in vivo) conducted by the sponsor (TYRX, Inc., Monmouth Junction, NJ, USA). The studies are retrospective/prospective in the sense that they were conducted to support the 510(k) submission for this new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable for this type of medical device submission. Ground truth, in the context of diagnostic or AI devices, typically refers to expert interpretation of data or pathological findings. The assessment here is based on physical, chemical, and biological performance characteristics, verified by standard laboratory and in vivo animal testing, rather than human expert interpretation of a "test set" of images or patient data.
4. Adjudication Method for the Test Set
This is not applicable for this type of medical device submission. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations within diagnostic studies, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This is not applicable for this type of medical device submission. MRMC studies are used to evaluate the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a physical implantable medical device, not an AI or diagnostic software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable for this type of medical device submission. "Standalone performance" refers to the performance of an AI algorithm on its own. The AIGIS R is a physical implantable device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Bench Testing Results: Demonstrating material degradation, chemical structure integrity post-sterilization, and absence of interactions between components.
- ISO Standard Compliance: Adherence to ISO 10993 for biocompatibility and ISO 11137 for sterility.
- In vivo Model Results: Demonstrating antimicrobial effectiveness (AME) in an animal model of bacterial challenge and demonstrating that the device does not interfere with CIED function.
8. The Sample Size for the Training Set
This is not applicable. The AIGIS R is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the computational sense. The "training" or development of the device would involve materials science, engineering, and preclinical testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for an AI algorithm. For the development and testing of the physical device, the "ground truth" (i.e., the desired properties and performance) was established through:
- Regulatory Standards: Compliance with ISO standards for biocompatibility and sterility.
- Predicate Device Performance: Benchmarks set by the established safety and efficacy profile of the AIGISRx® (K063091) predicate device.
- Scientific and Engineering Principles: Underlying principles for material science, chemical stability, and antimicrobial efficacy testing.
§ 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.