(90 days)
AIGISRx® N is intended to hold a vagus nerve stimulator securely in order to create a stable environment when implanted in the body. AIGISRx® N 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 or defibrillator. This device is only intended to be used in conjunction with vagus nerve stimulators implanted in the infraclavicular fossa or anterolateral abdominal wall.
AIGISRx® N is a dual component (resorbable and non-resorbable) sterile prosthesis designed to hold a vagus nerve stimulator securely to create a stable environment when implanted in the body. It is constructed of knitted filaments of polypropylene that are coated with a bioresorbable polyarylate polymer containing the antimicrobial agents rifampin and minocycline.
The provided text describes the AIGISRx® N, a surgical mesh device, and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the specific details requested in your prompt related to AI/algorithm performance.
The document is a 510(k) summary for a medical device (surgical mesh), which primarily focuses on demonstrating substantial equivalence to a previously cleared device. It discusses the device's physical, chemical, and mechanical properties, biocompatibility, sterility, and intended use.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria & Reported Performance (Table): The document states that the new device has the "same" characteristics as the predicate device (mesh knit, suture retention, tear, burst strength) and that "bench testing shows that gamma sterilization has no detrimental effect." It also mentions "Standard ISO 10993 testing demonstrated the biocompatibility and safety of the device." However, specific numerical acceptance criteria (e.g., minimum burst strength, maximum allowed bacterial growth) and the exact performance results against those criteria are not provided.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for a study): The document refers to an "in vivo functionality study showed that AIGIS devices do not alter or interfere with an implantable pacemaker or defibrillator" and an "in vivo model of bacterial challenge" for the antimicrobial agents. However, these are mentioned broadly to support the device's characteristics or an active ingredient's effect, not as a detailed study report with the specific elements you're asking for (test set size, ground truth establishment, expert involvement, etc.). There is no mention of an algorithm or AI in this document, therefore, details related to AI performance studies are absent.
- Training Set Sample Size & Ground Truth: Since no AI/algorithm study is detailed, there's no information about a training set.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (surgical mesh), not on evaluating the performance of an AI/algorithm. Therefore, the specific details you requested regarding acceptance criteria, study methodologies, and AI performance are not available in this document.
§ 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.