(83 days)
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 Composix™ L/P Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). The mesh, Composix™ L/P, is a low profile, nonabsorbable, sterile prosthesis designed for the reconstruction of soft tissue deficiencies, previously cleared under K061754. It is constructed of one layer of large pore polypropylene mesh and one layer of expanded polytetrafluoroethylene (ePTFE) stitched together with PTFE monofilament. The Composix™ L/P Mesh described above will be preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K092726. The positioning system is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Composix™ L/P Mesh. Additionally, all sizes of the proposed product will be packaged with an Introducer Tool. The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll the proposed device in order to facilitate laparoscopic introduction. The Introducer Tool is identical to that included and cleared under the Composix® L/P Mesh K061754.
The provided 510(k) summary (K102766) describes a medical device, the Composix™ L/P Mesh with Echo PSTM Positioning System, which is a combination of two previously cleared devices. It is important to note that this submission is for a combination device and relies heavily on the substantial equivalence to its predicate devices rather than a de novo study demonstrating novel performance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards; material recognized as biocompatible (for Introducer Tool) | Biocompatibility testing in accordance with ISO 10993-1 standards was conducted on the proposed device (mesh and positioning system), and the results indicate it is biocompatible. No biocompatibility testing was conducted on the Introducer Tool as 304 Stainless Steel is a recognized biocompatible material (ASTM F899-09e1). |
| Functional Performance | Meet product specifications and intended uses, demonstrating safe and effective deployment and positioning. | Bench testing and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended uses. |
| Material Equivalence | Materials of the mesh, positioning system, and introducer tool must be equivalent or have recognized biocompatibility to predicates. | Composix™ L/P Mesh: same physical attributes, performance characteristics, and materials as predicate Bard Composix™ L/P Mesh (K061754). |
| Echo PSTM Positioning System: maintains same intended use, physical attributes, performance characteristics, and materials as Mesh GPSTM Deployment Balloon (K092726), with minor shape and inflation mechanism changes. | ||
| Introducer Tool: identical to previous version (K061754) made of 304 Stainless Steel (recognized biocompatible). | ||
| Intended Use Equivalence | Intended use should be equivalent to predicate devices. | Composix™ L/P Mesh: same indication as predicate mesh (reconstruction of soft tissue deficiencies, repair of hernias and chest wall defects). |
| Echo PSTM Positioning System: intended to facilitate delivery of soft tissue prosthetics during laparoscopic hernia repair (same as predicate deployment balloon). | ||
| Safety and Effectiveness | Overall demonstration of safety and effectiveness, leading to substantial equivalence. | All test results support the safety and effectiveness of the device for its intended use and demonstrate substantial equivalence to its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for a "test set" in the context of a clinical performance study. The studies mentioned are:
- Biocompatibility testing: Conducted on the proposed device (mesh and positioning system).
- Bench testing: Conducted on the proposed device design.
- In vivo simulated use experiments: Conducted on the proposed device design.
The nature of these tests suggests they are laboratory or animal-based, not human clinical trials with a specific "test set" of patients.
Data Provenance: The data provenance is not specified in terms of country of origin or retrospective/prospective. Given the type of tests described (bench, in vivo simulated use), it is safe to assume these are prospective experiments/tests conducted for the purpose of this submission, likely within a laboratory or controlled setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies performed (biocompatibility, bench, in vivo simulated use) do not typically involve human expert "ground truthing" in the way a diagnostic AI device would. The "ground truth" for material biocompatibility is based on ISO standards, and for functional performance, it's against design specifications and intended use.
4. Adjudication Method for the Test Set
This information is not applicable/provided as the described studies are not clinical trials or diagnostic performance studies that would involve expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh system, not an AI-assisted diagnostic tool where human readers would assess images with and without AI assistance. The document focuses on the physical and functional performance of the medical device itself and its equivalency to existing products.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device (surgical mesh and deployment system), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- International Standards: For biocompatibility (ISO 10993-1, ASTM F899-09e1).
- Product Specifications: For bench testing and in vivo simulated use experiments, the device performance is measured against pre-defined product specifications and intended use requirements.
- Predicate Device Performance/Characteristics: A significant part of the "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.
8. The Sample Size for the Training Set
This information is not applicable/provided. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no training set for this type of medical device submission.
§ 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.