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DynaMesh®- POSTERIOR serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®- POSTERIOR is indicated for repairing hernias in all current extraperitoneal surgical techniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-POSTERIOR is a textile structure knitted from non-absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 from Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a ziqzag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates a rapid orientation and visual monitoring of whether the mesh is positioned tension-free. The used green dye is Phtalocyanine green, CAS1328-53-6, PG7 from BASF. DynaMesh®-POSTERIOR is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-POSTERIOR will be packed in a cardboard box. Within the cardboard box the device will be doublepacked in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

The provided text is a 510(k) summary for the DynaMesh®-POSTERIOR surgical mesh. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

The document describes a medical device, a surgical mesh, which is a physical implant, not an AI/ML software device. The listed "Summary of Non-Clinical and Clinical Data" refers to laboratory bench tests (e.g., Burst Strength Test, Tensile Strength, Porosity Test) conducted on the physical mesh to demonstrate its performance and substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance from an AI/ML study, sample sizes for test/training sets, data provenance, expert ground truth adjudication, MRMC studies, or standalone algorithm performance. This information is not relevant to the type of device and submission described in the provided text.

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DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical thecniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the ziqzag-stripes are in the craniocaudal direction. The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF. DvnaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

The provided text is a 510(k) Summary for the DynaMesh®-VENTRAL surgical mesh, which is a medical device for repairing hernias. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it does not contain the detailed study information typically found in an FDA PMA (Premarket Approval) application or a clinical trial report.

Here's a breakdown of the requested information based on the provided text, with explanations for what is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical thresholds against which the DynaMesh®-VENTRAL was evaluated. Instead, it lists "Laboratory Bench Tests" that were conducted to "demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products." The performance details for each test (e.g., specific burst strength values, tensile strength values) are not reported in this summary.

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

The document mentions "various Laboratory Bench Tests" but does not specify the sample sizes used for these tests. Data provenance (country of origin of the data, retrospective or prospective) is also not mentioned for these bench tests. Given they are bench tests on the device materials, "country of origin of the data" would likely refer to the testing facility, which is not specified.

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

This information is not applicable or not provided in this type of submission. Bench tests typically involve laboratory technicians or engineers performing standardized tests, not medical experts establishing ground truth in a clinical context.

4. Adjudication method for the test set

This information is not applicable or not provided. Adjudication methods are typically used in clinical studies involving human interpretation or outcomes, not for material property bench tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done or mentioned. This document describes a 510(k) submission based on substantial equivalence to a predicate device, primarily supported by bench testing of material properties, not clinical comparative effectiveness studies involving human readers.

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

Not applicable. The DynaMesh®-VENTRAL is a physical surgical mesh, not a software algorithm or AI device.

7. The type of ground truth used

For the bench tests, the "ground truth" would be the physical properties and performance of the device as measured by standardized laboratory methods. This isn't "expert consensus," "pathology," or "outcomes data" in the clinical sense. These tests aim to objectively measure the material characteristics of the mesh. The comparison is made against "accepted norms" and the performance of the predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As mentioned above, this is not an AI/ML algorithm.

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DynaMesh®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is indicated for repairing incisional hernias in all current extraperitoneal surgical techniques.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is a textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber. Polyvinylidene Fluoride (PVDF) has been used for approximately 20 years for long-term implants in cardiac and vascular surgery because of its biocompatibility and durability. PVDF is a high performance polymer material with very high material purity. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a pattern of zig-zag marking stripes as visual aid to the clinician facilitating correct mesh positioning; the mesh is correctly positioned when the zig-zag stripes are in the craniocaudal direction. DynaMesh®-CICAT is supplied as a sterile, flat sheet of material without any coatings or additives. The FEG Textiltechnik's DynaMesh®-CICAT will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.

The provided document is a 510(k) summary for the DynaMesh®-CICAT surgical mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical (bench) testing.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based only on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria with numerical targets. Instead, it states that various bench tests were conducted "to demonstrate performance to an accepted norm and/or substantial equivalence to the predicate products." This implies the acceptance criteria were based on meeting established norms for surgical meshes or demonstrating performance comparable to the predicate devices.

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

The document does not specify the sample sizes used for each of the listed bench tests. It only states that "Various Laboratory Bench Tests have been conducted." The data provenance is from "FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH" in Germany, and the tests are described as non-clinical (bench tests), implying they were conducted in a laboratory setting. There is no indication of retrospective or prospective human data.

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

This information is not applicable to the provided document. The "ground truth" here refers to the physical properties of the mesh determined through engineering/mechanical testing, not human-interpreted data. Therefore, there's no mention of experts or their qualifications for establishing ground truth in this context.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used when human interpretation of data (e.g., medical images) is involved and discrepancies need to be resolved. For mechanical bench tests, the measurements are generally objective and standardized.

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 such study was performed or mentioned. This document describes a surgical mesh, not an AI-powered diagnostic device.

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

No such study was performed or mentioned. This information pertains to AI algorithms, which are not relevant to this medical device.

7. The type of ground truth used

The ground truth used for the device evaluation was engineering/mechanical measurement data obtained from laboratory bench tests. These tests directly measure physical properties like burst strength, tensile strength, tear resistance, suture pullout strength, tri-elasticity, and porosity.

8. The sample size for the training set

This information is not applicable as there is no machine learning or AI algorithm involved that would require a training set. The device is a physical surgical mesh.

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

Not applicable, as there is no training set for an AI algorithm.

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DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.

The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material. DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements. FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes. The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags: - the inner transparent bag contains the device only - the outer transparent bag contains the inner bag and four adhesive labels for patient records. The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.

The provided text does not describe acceptance criteria for a medical device or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for a surgical mesh (DynaMesh-PP) seeking substantial equivalence to predicate devices.

The document focuses on comparing the DynaMesh-PP to existing legally marketed polypropylene meshes based on design, materials, manufacturing processes, and physical properties. It does not detail specific performance acceptance criteria or a study designed to demonstrate the device meets such criteria.

The tables provided (pages 3 and 4 of the submission) show a technological comparison to predicate devices, listing various physical features and their measured values for both the subject device (DynaMesh-PP) and the predicate device (Sofradim Parietene Mesh). These are presented to demonstrate similarity, not necessarily to meet pre-defined acceptance criteria for performance in a clinical or simulated-use context.

Therefore, I cannot populate the requested table or answer the questions as the information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on comparison to existing devices, not a report on acceptance criteria and performance from an independent study.

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