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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 2.0™ Lap System is intended to be used to facilitate the delivery of soft tissue prostheses during laparoscopic hernia repair.

The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh is a low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia renair.

VENTRALIGHT™ ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis designed for the reconstruction of soft tissue deficiencies. The low profile mesh facilitates laparoscopic deployment and the pre-sized shapes offer ready-to-use benefits. VENTRALIGHT™ ST Mesh 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 uncoated fascial side of the mesh allows for 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 that separates the mesh from underlying tissue and visceral organ surfaces to minimize tissue attachment to the mesh. Shortly after hydration, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The VENTRALIGHT™ ST Mesh described above will be packaged pre-assembled to the ECHO 2.0TM Lap System. The ECHO 2.0™ Lap System is made of a deployment frame (pre-shaped nitinol wire encased in a thermoplastic coated nylon sleeve with a center hoisting loop) which is pre-attached to the VENTRALIGHT™ ST Mesh with connectors. Once inserted, the deployment frame facilitates laparoscopic deployment without the need of ancillary devices. Once initial mesh fixation is complete, the ECHO 2.0™ Lap System is completely removed from the body by cutting the center hoisting loop at the patient's skin level and pulling the deployment frame off the mesh and directly out of the abdominal cavity through a 10mm (or larger) trocar.

The provided text is a 510(k) Summary for a medical device (ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh). It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

However, the document does not contain a table of acceptance criteria nor a detailed study description with specific numerical performance metrics, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a study proving a device meets acceptance criteria. The performance data section lists the types of tests conducted, but not their results or specific acceptance thresholds.

Given the information provided, I cannot fulfill all parts of your request as the specific data regarding acceptance criteria and detailed study results are not present in this 510(k) summary. I can only describe the tests performed, not their outcomes or how they met specific acceptance criteria.

Here's a breakdown of what can be extracted from the text, and what is missing:

What can be extracted:

• Types of performance tests performed: Biocompatibility, Bench-top (simulated use, mesh integrity, ball burst, attachment strengths), Mechanical (nylon peel strength, hoisting loop attachment, crimp integrity), and Porcine Animal Model (simulated use, surgeon feedback).
• Absence of some types of studies: No electrical safety/EMC or software verification/validation were required as the device doesn't have such components. No clinical study was required.
• Intended Use & Indications for Use: The device is for reconstruction of soft tissue deficiencies (hernias), and the Lap System facilitates delivery of prostheses during laparoscopic hernia repair.

What is missing (and therefore cannot be provided in the table or detailed descriptions):

• Specific Acceptance Criteria: The document lists types of tests, but not the quantitative or qualitative criteria for success (e.g., "Ball Burst strength > X Newtons").
• Reported Device Performance: No actual results from the tests are provided, only that they were conducted "in support of the substantial equivalence determination."
• Sample Sizes: While tests were done, e.g., in a "porcine animal model," the number of animals or the number of samples for bench testing is not specified.
• Data Provenance: Not specified for bench tests. For biocompatibility, it states testing was conducted "in accordance with FDA Blue Book Memorandum #G95-1" and "leveraged from the primary predicate device." The animal model is porcine. The origin (country/institution) is not mentioned.
• Number of Experts/Qualifications for Ground Truth: Not applicable as specific ground truth data for performance metrics is not provided. Surgeon feedback was gathered for the porcine model, but details on "experts" or the number of surgeons are not given.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Explicitly states "No clinical study was required." This implies no MRMC study.
• Standalone Performance: While "Performance Testing - Bench" and "Performance Testing - Mechanical" describe tests on the device itself, the results establishing its standalone performance against defined acceptance criteria are not provided.
• Type of Ground Truth Used: For the porcine model, it's "surgeon feedback on product performance." For other tests, it would typically be defined metrics based on engineering specifications or ISO standards, but these are not detailed.
• Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/software device. The document explicitly states "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."
• Ground Truth for Training Set: Not applicable.

Based on the provided text, here is what can be inferred/extracted, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests (bench, mechanical, or animal model).
• Data Provenance:
  • Biocompatibility: "leveraged from the primary predicate device" and conducted "in accordance with FDA Blue Book Memorandum #G95-1" and ISO 10993-1.
  • Animal Model: Porcine animal model. Country of origin not specified. Retrospective/Prospective not specified, but typically prospective for animal studies.

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

• Not applicable/Not provided in detail. For the porcine model, "surveys which captured surgeon feedback on product performance" were used. The number or specific qualifications of these surgeons are not mentioned. For other tests, "ground truth" would be established by engineering specifications or compliance with standards, not expert consensus on performance data.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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. The document explicitly states: "No clinical study was required in support of the proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh." This device is a physical surgical mesh and delivery system, not an AI or imaging device, so an MRMC study is not relevant.

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

• Yes, various "standalone" performance tests were conducted on the device components and the assembled system. These include:
  • Biocompatibility Testing
  • Bench-Top Simulated Use
  • Mesh Integrity (following simulated use)
  • Ball Burst
  • Connector to Mesh Attachment Strength
  • Connector to Deployment Frame Attachment Strength
  • Nylon Peel Strength
  • Center Hoisting Loop to Deployment Frame Attachment Strength
  • Crimp Integrity
• However, the results of these tests meeting specific acceptance criteria are not detailed in this summary.

7. The type of ground truth used:

• For the performance testing, the ground truth would be based on engineering specifications, material properties, and compliance with recognized standards (e.g., ISO for biocompatibility).
• For the porcine animal model, "surgeon feedback on product performance" acted as a form of experiential ground truth.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not an AI/software device that would require a "training set." The document explicitly states: "The proposed ECHO 2.0™ Lap System with VENTRALIGHT™ ST Mesh does not contain software."

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 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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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.

• PGA pullout strength testing completed.
• Burst strength testing completed.
• Tear strength testing completed.
• Suture retention strength testing completed.
• Dry bond strength testing completed.
• Hydrogel disruption testing after laparoscopic deployment completed.

Conclusion: "Results of testing demonstrate that the Ventralight ST Mesh design meets product specifications and intended uses." |
| Biocompatibility: Device materials should be biocompatible and comparable to the predicate device. | Biocompatibility Testing: Completed (similar to predicate device, as there were no material changes). |
| Tissue Interaction (reduced attachment, ingrowth): The device should demonstrate similar tissue ingrowth and minimal tissue attachment as the predicate device. | Animal Study Results (4-week post-implantation porcine model, comparative): Evaluated:

• Tissue attachment
• Mesh contracture
• Tissue in-growth
• Host inflammatory and fibrotic response
  Conclusion: Results indicated similar performance to the predicate device ("performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."). |
  | Sterilization: Device sterilization method should be effective and comparable to the predicate. | Sterilization: Stated as "the same as the predicate device." |
  | Packaging: Device packaging should maintain integrity and sterility. | Packaging: Stated as "the same as the predicate device." Tested seal strength and package qualification. |

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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