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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 2™ Positioning System is intended to facilitate the delivery and positioning of soft tissue prostheses during laparoscopic hernia repair.

The Subject Device, VENTRALIGHT™ ST Mesh with ECHO 2TM Positioning System is provided sterile for single use and consists of an implantable surgical mesh (VENTRALIGHT™ ST Mesh) with a pre-attached mesh positioning system (ECHO 2™ Positioning System). The Subject Device is designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair.

The provided text describes the regulatory clearance for a medical device, the VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System, and its substantial equivalence to a predicate device. However, it does not detail specific acceptance criteria and the comprehensive study results in the format requested for an AI/algorithm-based device.

This document pertains to a surgical mesh and a positioning system, which are physical medical devices, not an AI or algorithm-based system. Therefore, many of the requested sections related to AI/algorithm performance metrics (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, and "The VENTRALIGHT™ ST Mesh with ECHO 2™ Positioning System passed all the test requirements and demonstrated substantial equivalence to the test results of the Predicate Device." However, the specific numerical acceptance criteria or the raw performance data are not provided in this summary. The general categories of testing and the conclusion of meeting criteria are mentioned.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: The document states "All samples tested met the established acceptance criteria" for product testing and cadaveric studies, but it does not specify the numerical sample sizes used for these tests.
• Data Provenance: Not specified.
• Retrospective/Prospective: Not specified, although cadaveric studies would inherently be prospective in their execution given the study design.

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 information is not applicable as this isn't an AI/algorithm device requiring expert ground truth for classification. The "ground truth" for this physical device is based on objective measurements and observations during mechanical and cadaveric testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. Clinical studies were not performed, and this is not an AI-assisted device for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and successful performance in standardized biological tests. For product testing (mechanical and simulated use) and cadaveric studies, the "ground truth" or acceptance criteria are based on pre-defined engineering specifications, functional requirements, and safety/feasibility observations relative to the predicate device.

8. The sample size for the training set:

Not applicable. There is no AI/algorithm training set for this physical device.

9. How the ground truth for the training set was established:

Not applicable.

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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 the repair of hernias.

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. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging 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 30 days.

The provided text describes a 510(k) summary for the Ventralight ST Mesh, a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on quantitative performance metrics like sensitivity, specificity, or F-score often associated with AI/ML-based devices.

Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable in this context.

Here's an analysis based on the information provided, highlighting the aspects that are relevant to this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of traditional surgical mesh device, "acceptance criteria" are generally tied to demonstrating substantial equivalence to a legally marketed predicate device, focusing on similar safety and effectiveness. The performance is assessed through non-clinical testing.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated with specific numbers, but the document mentions a "4 week post-implantation study in a porcine model." This implies a limited number of animal subjects. Bench testing also does not specify the number of samples tested for each metric, but these are typically standardized tests performed on multiple samples.
• Data Provenance: The animal study was conducted in a "porcine model," indicating an animal study rather than human clinical data. Bench testing is laboratory-based. This is prospective testing of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable here because "ground truth" in this context would refer to objective measurements from bench tests or histological evaluations from the animal study. These would typically be performed and interpreted by laboratory technicians or veterinary pathologists, not "experts" in the sense of clinical reviewers establishing diagnostic truth for AI.

4. Adjudication method for the test set

• Not applicable. Adjudication methods are used when multiple human readers interpret an image or clinical case and their interpretations need to be reconciled to establish a ground truth. For bench tests and animal studies, results are typically quantitative measurements or pathological findings with established protocols.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices, not for a surgical mesh.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the animal study: Pathology/Histology (e.g., evaluating tissue attachment, ingrowth, inflammatory response) and observational data from the porcine model.
• For bench testing: Objective physical measurements (e.g., strength values, disruption levels) using laboratory equipment and established test methods.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set in the computational sense. The "training" for the device's development would be through design iterations, material science knowledge, and manufacturing processes.

9. How the ground truth for the training set was established

• Not applicable. Since there is no training set in the AI/ML context, there is no "ground truth" to establish for a training set. The device design and materials are based on established engineering principles and prior knowledge from the predicate device.

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