(68 days)
The ACell UBM Surgical Mesh ML and MLPlus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.
The ACell UBM Surgical Mesh ML and MLPlus are composed of porcine collagen and are supplied sterile in sizes ranging from 16 cm² to 14x20 cm.
The provided text describes a 510(k) premarket notification for the ACell UBM Surgical Mesh ML and MLPlus. This document focuses on the regulatory clearance process for a medical device and does not contain information about a study proving device performance against specific acceptance criteria in the way you've outlined for an AI/ML medical device.
The main points from the document regarding "tests" are:
- Discussion of tests and test results: "The ACell Surgical Mesh ML and MLPlus were subjected to a number of tests to assess the biocompatibility and the performance of the materials. They passed the requirements of all tests and were shown to be safe and effective as surgical mesh devices as indicated."
This is a very general statement and does not provide specific acceptance criteria, reported performance metrics, or details of a study design that would fit the questions about AI/ML device performance.
Therefore, I cannot populate the requested table and answer many of your specific questions because the provided text is about a traditional medical device (surgical mesh) and its 510(k) clearance, not an AI/ML device and its performance study.
Here's why the questions cannot be answered from the provided text:
- Table of acceptance criteria and reported device performance: The document states "passed the requirements of all tests" but does not detail what those tests were, what their specific acceptance criteria were, or the quantitative performance metrics achieved by the device.
- Sample size, data provenance: Not applicable as no such studies demonstrating AI/ML performance are described.
- Number of experts, qualifications: Not applicable. The "tests" likely refer to material science, biocompatibility, and mechanical property tests, not expert-reviewed output.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This device is a surgical mesh, not an AI assisting human readers.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
In summary, the provided document is a 510(k) summary for a physical surgical mesh product. It details regulatory information, intended use, and general statements about passing safety and performance tests, but it does not contain the kind of detailed study information (especially concerning AI/ML performance, ground truth, expert review, sample sizes, etc.) that your questions are designed to extract.
§ 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.