(76 days)
The Herniamesh T-sling is a dual-component pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Pre-shaped Duel-component mesh Polypropylene and bioabsorbable polymer
The provided text describes a Premarket Notification for the Herniamesh T-Sling, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving device performance against those criteria in the context of diagnostic accuracy.
However, from the provided text, we can extract the "acceptance criteria" as the functional requirements and characteristics of surgical meshes that the Herniamesh T-Sling must meet or exceed to be considered substantially equivalent to predicate devices. The "study" refers to the performance data obtained through various tests.
Here's an attempt to structure the information based on your request, acknowledging that the document is a 510(k) submission, not a study report demonstrating diagnostic accuracy:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly defined by the properties of the predicate devices (Ethicon TVT and Injectx Inc BioSling™). The study demonstrates that the Herniamesh T-Sling's performance "meets or exceeds" these requirements.
| Feature | Acceptance Criteria (Predicate Devices - Ethicon TVT ranges or description) | Reported Device Performance (Herniamesh T-Sling) |
|---|---|---|
| Burst Strength (10² Kpa) | 55 ± 3 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™) | 28.4 |
| Suture Retention (N) | warp 52 ± 9, weft 51 ± 7, 45° 57 ± 3 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™) | warp 43, weft 55, 45° 52 |
| Pore Size | Substantially Equivalent, Porosity 87% (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™) | 797.4μ & 228.3μ, Porosity 62.4% |
| Tensile Strength | warp 23 ± 6, weft 15 ± 5, 45° 14 ± 5 (Ethicon TVT) / Substantially Equivalent (Injectx Inc BioSling™) | warp 31.1, weft 33.1, 45° 29.7 |
| Tissue Ingrowth | Complete tissue incorporation of implant (Ethicon TVT) / Not Tested (Injectx Inc BioSling™) | Complete tissue incorporation of implant |
Note on Burst Strength & Suture Retention: While the Herniamesh T-Sling's specific values for Burst Strength appear lower than the Ethicon TVT's reported value, and its Suture Retention warp value is lower, the document explicitly states: "the technological differences meet or exceed the functional requirements of surgical meshes compared to the predicate devices" and "The physical and mechanical characteristics of the Hermiamesh T-Sling meet or exceed those of the predicate devices." This suggests that the listed predicate values might not represent a strict lower bound for substantial equivalence, or there are other considerations not fully detailed in this excerpt that support the "meets or exceeds" claim. This highlights a common aspect of 510(k) submissions where the "acceptance criteria" are not always hard numerical thresholds for superiority but rather for safe and effective equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices/cases for each test, but implied to be sufficient for mechanical, biocompatibility, and in vivo testing for the Herniamesh T-Sling. For the predicate device data (Ethicon TVT), the Burst Strength and Suture Retention values are presented with standard deviations (e.g., 55 ± 3, 52 ± 9), indicating multiple measurements were taken, likely from a sample of devices.
- Data Provenance:
- Herniamesh T-Sling: Performance data comes from "mechanical testing, scanning electron microscopy, biocompatibility and in vivo safety and effectiveness testing" conducted on the Herniamesh T-Sling. The location of these tests is not specified, but the applicant is "Herniamesh USA, Inc."
- Ethicon TVT (Predicate): Values for Prolene TVT were taken from the textbook: Prostheses and Abdominal Wall Hemias by Dr. Robert Bendavid (pages 197, 200). This indicates retrospective data collection from published literature.
- Injectx Inc BioSling™ (Predicate): Described as "Substantially Equivalent" for most mechanical properties, indicating a comparison against its own predicate or established benchmarks, but no specific values are given. "Not Tested" for Tissue Ingrowth for this predicate.
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 type of submission. This document describes the characterization of a medical device (surgical mesh) through physical, mechanical, and biological testing, not a diagnostic algorithm where expert ground truth is typically established (e.g., for image interpretation).
- The "ground truth" for the test set here refers to the actual measured physical and biological properties of the device and its predicates, established through standard scientific methods and measurements.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used in studies involving human interpretation or subjective assessments, often with multiple readers, to resolve discrepancies and establish a consensus ground truth. This is not relevant for the objective mechanical and biological testing described for a surgical mesh.
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 document is a 510(k) submission for a surgical mesh, not an AI-based diagnostic device. Therefore, no MRMC study involving human readers or AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. The device is a surgical mesh, not an algorithm. Therefore, no standalone algorithm performance study was performed.
7. The type of ground truth used:
- The "ground truth" for the Herniamesh T-Sling and the predicate devices is based on objective measurements and observations from:
- Mechanical Testing: Burst Strength, Suture Retention, Tensile Strength.
- Microscopy: Pore Size (from scanning electron microscopy).
- Biocompatibility Testing: Used to assess biological interaction/safety.
- In Vivo Testing: To assess safety and effectiveness in a living organism, including "Complete tissue incorporation of implant" (which could be verified by histological examination of explanted tissue).
8. The sample size for the training set:
- This information is not applicable. This document focuses on demonstrating the performance of a physical medical device (surgical mesh) through testing, not on training a machine learning algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable. As there is no machine learning model involved, there is no training set or associated ground truth establishment process.
§ 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.