(72 days)
Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
This document describes a 510(k) premarket notification for a new surgical mesh and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a diagnostic algorithm or AI device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use.
However, I can extract the relevant information that is available and indicate when specific details are not provided in the document.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria and corresponding performance values for the TyRx Surgical Mesh are not explicitly stated in terms of a table with quantitative metrics. The submission focuses on demonstrating comparability and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated to be biocompatible (TyRx Surgical Mesh and polyarylate polymer) |
| Satisfactory tissue ingrowth | Animal testing demonstrated satisfactory tissue ingrowth compared to control, evidenced by histopathology. |
| Comparability to predicate devices for intended use | Non-clinical laboratory testing performed in accordance with FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrated that the device is comparable to standard surgical mesh devices. |
| Proper handling (stiffness facilitation) | Resorbable coating provides additional stiffness to the mesh to facilitate intraoperative handling during placement. |
| Resorption properties | Polymer resorbs in approximately 90 days. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions "animal testing" and "non-clinical laboratory testing." It does not specify the sample size (number of animals or test replicates) for either of these.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the company is based in Monmouth Junction, NJ, USA, but this doesn't confirm where the testing took place. The testing was "non-clinical laboratory testing" and "animal testing," which are typically considered prospective in nature for evaluating a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "histopathology" for evaluating tissue ingrowth. This implies expert assessment. However, the number of experts and their specific qualifications (e.g., "veterinary pathologist with 10 years of experience") are not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test results.
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
- MRMC Study Done? No. This device is a surgical mesh, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as described (human readers with/without AI assistance) is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance? No. This device is a physical surgical mesh, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal testing evaluating tissue ingrowth, the ground truth was established through histopathology, which typically involves examination and interpretation by a pathologist.
8. The sample size for the training set
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
§ 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.