(84 days)
The Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PSTM Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
The proposed Ventralight™ ST Mesh with Echo PSTM Positioning System and Composix™ L/P Mesh with Echo PSTM Positioning System devices both comprise of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon).
The Ventralight™ ST Mesh is a low profile, sterile, single use device indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. This device is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel that is resorbed from the site in less than 30 days.
The Composix™ L/P Mesh is a low profile, nonabsorbable, sterile prosthesis indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. It is constructed of one layer of large pore polypropylene mesh and one layer of expanded polytetrafluoroethylene (ePTFE) stitched together with PTFE monofilament.
Each of the meshes described above will be sold pre-attached to the Echo PSTM Positioning System. The positioning system is composed of a nylon balloon that is preattached to the mesh via use of polycarbonate connectors, and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the prostheses.
Both of the proposed devices will also include an Introducer Tool and inflation assembly accessory designed to aid the user in laparoscopic introduction and inflation of the mesh/positioning system assembly.
The change described in this submission is a modification solely to the design of the Echo PSTM Positioning System which is sold pre-attached to both meshes and is identical in both products, with no change to either of the permanently implantable neemesh components or related accessories included with the device.
The inflation tube component of the positioning system will be modified to include an anchor which will improve the connection between the tube and associated inflation assembly. This same inflation tube component of the positioning system is also being modified to include white markings which more clearly identify the cutting point of the tube to the user.
The provided text describes a 510(k) submission for two hernia repair mesh devices with an attached positioning system: the Ventralight™ ST Mesh with Echo PSTM Positioning System and the Composix™ L/P Mesh with Echo PSTM Positioning System. The submission focuses on a modification to the Echo PSTM Positioning System, specifically to the inflation tube component.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or a detailed table of reported device performance metrics in the format requested. Instead, it makes general statements about the device meeting specifications and being substantially equivalent to predicates.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Devices are biocompatible per ISO 10993-1 standards. |
| Product Specifications & Intended Uses | Bench testing and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses. |
| Safety and Effectiveness | All test results support the safety and effectiveness of the device for its intended use. |
| Substantial Equivalence | Demonstrated that the proposed device is substantially equivalent to its predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set in either the biocompatibility testing, bench testing, or in vivo simulated use experiments. It also does not provide information on the data provenance such as the country of origin or if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable to this device and submission. The device is a surgical mesh with a positioning system, not an AI/imaging diagnostic device that requires expert review to establish ground truth for a test set. The efficacy and safety are assessed through biocompatibility, bench testing, and in vivo simulated use experiments, not through expert reading of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated in point 3. There is no mention of adjudication methods as this is not an AI/imaging diagnostic device.
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 section is not applicable for the reasons stated in point 3. This is not an AI-assisted diagnostic device, so a MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable for the reasons stated in point 3. This device does not have an "algorithm only" component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (surgical mesh and positioning system), the "ground truth" for the performance claims would be established through:
- Biocompatibility standards: Adherence to ISO 10993-1.
- Product specifications: Meeting predefined engineering and design requirements in bench testing.
- Intended uses: Successful performance in "in vivo simulated use experiments" that replicate the laparoscopic deployment, unrolling, positioning, and placement of the prostheses. The specific metrics for success in these simulations are not provided, but would constitute the "ground truth" for functional performance.
8. The sample size for the training set
This section is not applicable. This is not an AI device that requires a training set. The "design modification" underwent testing, not training.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated in point 8.
§ 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.