(23 days)
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.
The proposed Ventralight™ ST Mesh with Echo PS™ Positioning System is comprised of a permanently implantable mesh with a pre-attached disposable mesh positioning system (mesh deployment balloon). All product sizes include an inflation assembly to be used with the mesh positioning system and some will also include an Introducer Tool designed to aid the user in laparoscopic introduction of the entire mesh/positioning system assembly.
The Ventralight™ ST Mesh is a low profile, sterile, single use device 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. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for complete tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30days. The Ventralight ST Mesh to be used with the proposed device is identical to that cleared via K 122436.
The Ventralight™ ST Mesh described above will be packaged preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon that is preattached to the mesh and is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement. The positioning system is inflated via use of the included inflation assembly, which is also identical to that cleared with the predicate positioning system under K122436.
For user convenience, specific sizes of the proposed product will also include an Introducer Tool which is intended to facilitate delivery to the operative site. The Introducer Tool included with the proposed product is identical to the Introducer Tool cleared under K122436 which consists of a handle with a thin stainless steel rod and a Tcap. The device is split into two pieces along the length of the entire rod and attached on one end to the handle.
The provided text describes a medical device submission (K130968) for the Ventralight™ ST Mesh with Echo PST™ Positioning System. This submission is a 510(k) for a line extension, indicating it's considered substantially equivalent to a previously cleared device (K122436). As such, the performance data provided relies heavily on the predicate device.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a line extension and the key components (mesh, positioning system, introducer tool, inflation assembly) are identical to the predicate device, specific acceptance criteria in terms of numerical performance metrics (like accuracy, sensitivity, specificity) for a diagnostic AI device are not explicitly defined in the provided text. Instead, the "acceptance criteria" are based on demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: Device is biocompatible as per its intended use and ISO 10993 requirements. | Biocompatibility testing previously conducted (K122436) applies and indicates biocompatibility. |
| Product Specifications Met: Device design meets product specifications and intended uses. | Bench testing results and in vivo simulated use experiments demonstrate the device meets product specifications and intended uses. |
| Safety and Effectiveness: Demonstrate safety and effectiveness for intended use. | All test results (biocompatibility, bench, in vivo simulated use) support safety and effectiveness. |
| Identical Technological Characteristics: Key components (mesh, positioning system, introducer tool, inflation assembly) are identical to the predicate. | The Ventralight™ ST Mesh, Echo PSTM Positioning System, and (where applicable) the Introducer Tool and inflation assembly are all identical to those cleared under K122436. |
| Same Intended Use & Performance Characteristics: The mesh and positioning system maintain the same intended use and performance as the predicate. | The mesh has the same indications for use and performance characteristics. The positioning system maintains the same intended use and performance characteristics. |
| Line Extension Justification: The modification is a line extension to offer additional sizes. | The proposed modification is a line extension to offer four (4) additional sizes. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of an AI/diagnostic device's performance evaluation (e.g., number of cases or images). Instead, it mentions:
- Biocompatibility testing: "previously conducted (as presented via K122436)". No sample size or provenance given in this document.
- Bench testing: "Bench testing results". No sample size or specific provenance given.
- In vivo simulated use experiments: "in vivo simulated use experiments". No sample size or specific provenance given.
Given the nature of the device (surgical mesh and deployment system) and the fact that it's a 510(k) for a line extension, this is typical. The evaluation focuses on the physical and performance attributes of the device itself rather than the analysis of a dataset.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a surgical mesh and a deployment system, not an AI or diagnostic device that requires expert adjudication for ground truth of medical conditions.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of expert adjudication for medical condition assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is typically conducted for AI-assisted diagnostic devices to assess how AI impacts human reader performance. This device is a surgical mesh and deployment system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This type of study is for AI/algorithm performance. This device is a physical medical implant and surgical tool.
7. Type of Ground Truth Used
The "ground truth" for this device is based on:
- Physical and material properties: Biocompatibility (ISO 10993 standards), material specifications (polypropylene, polyglycolic acid, hydrogel coating).
- Functional performance: Bench testing to ensure the device meets specified functional design requirements (e.g., deployment, unrolling, positioning).
- Simulated use outcomes: In vivo simulated use experiments to assess how the device performs in a simulated surgical environment.
These are not "ground truths" in the sense of a medical diagnosis, but rather objective measurements and observations against engineering and performance specifications.
8. Sample Size for the Training Set
Not applicable. There is no training set for this type of medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set. The "ground truth" for the device's design and performance is established through engineering design, material science, and performance testing as described in point 7.
§ 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.