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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.

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.

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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.

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.

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