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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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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

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.

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