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Parietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ macroporous mesh is designed for extraperitoneal mesh placement only, for the repair of abdominal wall hernias by laparoscopic or open approach.

Parietene™ macroporous mesh is a non-absorbable synthetic surgical mesh made of two-dimensional (2D) monofilament polypropylene knitted textile.

Parietene™ macroporous mesh is offered in square flat sheet version (50cm x 50cm).

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues. The macroporous textile provides strength required to withstand biomechanical stresses throughout the healing period, while allowing for tissue ingrowth. As the textile integrates, host tissue ingrowth is intended to provide strength to the repair.

The detailed composition listed below refers to the estimated maximum amount of each material and substance to which a patient can be exposed when 1 unit of the largest size of Parietene™ macroporous mesh is implanted (i.e. PPM5050). This amount could be less if the mesh is trimmed by the practitioner prior to implantation.

Mesh composition: monofilament polypropylene yarn (up to 11.5 g)

This FDA 510(k) clearance letter is for a surgical mesh (Parietene™ Macroporous Mesh, PPM5050), not an AI-powered diagnostic device. Therefore, the requested information regarding AI device acceptance criteria, study methodologies (MRMC, standalone performance), expert ground truth establishment, training sets, and data provenance is not applicable to this document.

The document discusses the substantial equivalence of the new mesh size (50cm x 50cm) to previously cleared predicate devices based on:

• Performance testing: In-vitro (bench) tests for trocar compatibility, bursting strength, deflection, uniaxial tensile maximum force and elongation, and tear strength.
• Biocompatibility evaluation.
• Sterilization validation.
• Literature and MAUDE database review of predicate and reference devices.

There is no mention of an AI algorithm, human readers, or image interpretation in this clearance.

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ProGrip™ self-gripping polypropylene mesh is intended for use in reinforcement of abdominal wall soft tissue where weakness exists.

The ProGrip™ self-gripping polypropylene mesh rectangular and square shapes are indicated for inguinal and ventral hernia repair.

Progrip™ self-gripping polypropylene mesh is designed to allow extraperitoneal mesh placement for the repair of inguinal and ventral hernias.

Progrip™ self-gripping polypropylene mesh is made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side. Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial box or envelope with the eIFU leaflet and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial box or envelope (single pack configuration: 1 unit per commercial box or envelope).

The provided document is a 510(k) premarket notification summary for a medical device (ProGrip™ Self-Gripping Polypropylene Mesh). It does not include acceptance criteria or detailed study results that would typically be reported for an AI/Software as a Medical Device (SaMD).

This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria based on a clinical trial or a machine learning model's performance metrics. As such, the information required cannot be fully extracted based on the input document.

However, I can extract what is mentioned about performance data and the general approach:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/SaMD devices. Instead, it describes performance testing aimed at demonstrating substantial equivalence to a predicate device.

• Simulated use in cadaver model: Surgeons prepared, introduced through trocar, deployed, placed, and fixated mesh. Verified product use in contact with tissue.
• Simulated use in abdominal simulator for trocar passage.
• Electronic Instructions For Use (eIFU) checked for clarity and understandability.
  Compliance: "The human factors engineering process applied to the ProGrip™ Self-Gripping Polypropylene Mesh complied with the requirements of IEC 62366-1: 2015 and associated FDA guidance documents." |
  | Sterilization, shelf-life, shipping, and biocompatibility are not impacted by changes | Not explicitly stated as "acceptance criteria met" but rather "not impacted by the proposed change," implying that previous validations for the predicate device still hold. |

2. Sample Size Used for the Test Set and Data Provenance

Given this is a physical medical device (surgical mesh) and the performance data primarily consists of in vitro bench testing and human factors evaluation with cadaver/simulator models, the concept of a "test set" and "data provenance" (country, retrospective/prospective) as typically applied to AI/SaMD is not directly applicable.

• Sample Size for Test Set: Not specified in terms of number of cases or patients as it's not a clinical study on patient data for software performance.
  • For the in vitro bench tests, the number of samples tested for each physical/mechanical property is not provided.
  • For human factors evaluation, the number of participants (surgeons) or cadaver/simulator instances is not specified.
• Data Provenance: Not applicable in the context of this device's performance evaluation as described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. This type of detail is usually relevant for AI/SaMD where expert annotations establish ground truth for model training and evaluation. For this physical mesh device, expert involvement is mentioned in the human factors evaluation (surgeons using the device in simulated scenarios), but not for establishing "ground truth" in the AI sense.

4. Adjudication Method for the Test Set

Not applicable for this type of device and study description. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert review processes to resolve disagreements when establishing ground truth for AI/SaMD.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for a physical surgical mesh.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For physical/mechanical tests: The "ground truth" would be established by standardized measurement techniques and validated in vitro testing methods, with comparison to the predicate device's known performance characteristics.
• For human factors evaluation: The "ground truth" was established by the observations and feedback of participating surgeons during simulated use, confirming that the device could be used effectively and safely via the laparoscopic approach. Compliance with IEC 62366-1: 2015 indicates a structured approach to usability validation rather than a "ground truth" in the AI sense.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/SaMD, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no "training set."

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Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach. Transorb™ Self-Gripping Resorbable Mesh is made of a fully resorbable bi-dimensional Poly-L-lactide, poly-trimethylene carbonate copolymer (PLLA/TMC) monofilament textile with monofilament PLLA/TMC absorbable grips on one side. Transorb™ Self-Gripping Resorbable Mesh is available in different shapes and sizes. Transorb™ Self-Gripping Resorbable Mesh is a macro-porous mesh knitted from resorbable monofilament PLLA/TMC yarns. It has been designed to reinforce soft tissues where weakness exists by providing strength and tissue integration throughout the expected healing period. Transorb™ Self-Gripping Resorbable Mesh has absorbable PLLA/TMC grips on one side that facilitate positioning and contribute to fixation. The PLLA/TMC mesh and grips degrade and resorb in vivo by hydrolysis in 36 to 60 months and are metabolized by the body into CO2 and H₂O.

The provided text describes a 510(k) premarket notification for a medical device called "Transorb™ Self-Gripping Resorbable Mesh." This submission is to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria for a new claim typically associated with AI/ML devices or novel therapies. Therefore, the information typically requested in your prompt regarding acceptance criteria, study types, ground truth, and expert involvement for AI/ML performance is not present in this regulatory document.

However, I can extract the performance data and "acceptance" (pass/fail) criteria as presented for the biocompatibility and bench testing components of this surgical mesh.

Here's the information based on the provided text, structured as much as possible according to your request, but acknowledging the inherent differences in regulatory submissions for a surgical mesh versus an AI/ML diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (surgical mesh), "acceptance criteria" are implied by compliance with established standards and the outcome of "Pass" for various tests. The reported device performance is that it passed these tests, thus meeting the implied criteria.

Notes on Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh K191749), showing that differences do not raise new questions of safety or effectiveness. For biocompatibility tests, the criterion is to "Pass" the specific ISO 10993 standard. For bench tests, the conclusion is frequently stated as "substantially equivalent" to the predicate.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for each test in terms of a numerical count of units or animals. The text mentions broad categories like "PLLA/TMC monofilament yarn (up to 21g)" for composition and lists different product codes/sizes (e.g., TSB1510, TSB2020, TSB3030, TSB4030) that imply various units were tested across the different evaluations. For animal studies, it mentions "large animal model" (porcine) and "rabbit study."
• Data Provenance: The studies were internal preclinical (bench and animal) tests conducted by the manufacturer or their testing partners. There is no specific country of origin mentioned for the data, beyond the manufacturer being based in France. The studies are prospective in nature, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable in the context of your question. This document pertains to a physical medical device (surgical mesh) and its performance in bench and animal studies, not an AI/ML device requiring expert adjudication of outputs to establish ground truth from clinical images or data. The "ground truth" here is the physical and biological reality as measured by the various test methods (e.g., breaking strength, tissue ingrowth observations).

4. Adjudication Method for Test Set

• Not Applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used to establish a consensus ground truth in clinical evaluations, especially for AI/ML diagnostic tools. For this surgical mesh, performance is measured against established scientific and engineering principles via tests (e.g., ISO standards, ASTM standards, histological examination).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML-assisted ones) to assess the impact of the device on human reader performance. This submission is for a surgical implant, where such studies are not typically performed or required to demonstrate substantial equivalence. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This concept is specific to AI/ML algorithms evaluated independently of human interaction. The Transorb™ mesh is a physical implant, not a software algorithm. Its performance is evaluated through physical, chemical, and biological testing, outlined as biocompatibility, bench testing, and animal studies.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Compliance with International Standards: For biocompatibility (ISO 10993 series) and some physical properties (e.g., ISO 3801, ISO 9073-2, ISO 13934-1, ISO 4674).
• Predicate Device Comparison: For mechanical properties and physical aspects, the device's performance is compared to the predicate device (TIGR® Matrix Surgical Mesh, K191749), with substantial equivalence being the goal.
• Histology/Pathology: For animal studies, tissue repair, tissue integration, local tissue effects, and degradation profile were assessed via histological examination.
• Direct Measurement: For parameters like pore size, surface density, thickness, bursting strength, suture pull-out strength, etc., direct measurements are taken.

8. Sample Size for the Training Set

• Not Applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a training set. The term "training set" is not relevant in this context.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for this device, the question of how its ground truth was established is not relevant.

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Progrip™ Self-Gripping Polypropylene Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in procedures involving inguinal and ventral hernia repair by open approach.

Progrip™ self-gripping polypropylene mesh is a sterile non-pyrogenic device made of a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid (PLA) monofilament grips on one side.

Progrip™ self-gripping polypropylene mesh is available in different shapes and sizes.

The non-absorbable textile is designed to ensure long term reinforcement of soft tissues.

The monofilament polylactic acid grips facilitate placing and positioning the mesh, and they contribute to fixation of the mesh to the surrounding tissue for at least eight (8) weeks. The polylactic acid grips are bioresorbable. Over the time, they resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O. Preclinical studies showed that the polylactic acid material is essentially resorbed in 36 to 50 months post-implantation. However, the resorption period depends on numerous factors including patient-related factors.

Progrip™ self-gripping polypropylene mesh is a single use device, presented in a double sterile barrier packaging (two Tyvek® pouches). The packed device is terminally sterilized by Ethylene Oxide (EtO) and placed into a commercial envelope with the Instructions for Use (IFU) and Patient Implant Card (PIC). All the devices are packaged unitary in a commercial envelope (single pack configuration: 1 unit per commercial envelope).

The provided text is a 510(k) summary for the Progrip™ Self-Gripping Polypropylene Mesh (K232373). It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document discusses various performance tests conducted (sterilization, shelf-life, shipping, biocompatibility, in vitro bench tests) to demonstrate substantial equivalence to the predicate device. However, these are presented as evaluations against established standards and guidance documents, rather than against specific, numerical acceptance criteria for a new clinical study.

Furthermore, the document explicitly states: "This premarket submission does not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that no clinical study was performed for this 510(k) submission.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this type of data is not present in the provided text. The submission relies on non-clinical performance and a comparison to predicate devices to establish substantial equivalence.

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Parietene™ macroporous mesh is intended for the repair of hemias or other fascial deficiencies that require the addition of a reinforcing material.

The Parietene™ Macroporous Mesh is a non-absorbable synthetic surgical mesh made of bi-dimensional monofilament polypropylene textile. The Parietene™ Macroporous mesh is offered in a flat sheet and pre-cut mesh. The pre-cut mesh facilitates the repair of inguinal hernias via the anterior approach using a tension free technique. Parietene™ Macroporous Mesh is a single use device, presented sterile and unitary packaged in a single pouch and provided in a commercial box or sleeve with the labels and instructions for use. The device can be packaged in single pack (1 unit per sleeve) or multipack (3 or 6 units per box).

The provided text is a 510(k) summary for the Parietene™ Macroporous Mesh. It describes a mesh product for hernia repair and focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria based on a clinical study of its performance in patients.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and ground truth types cannot be found in this document, as it primarily deals with engineering and material equivalence.

However, based on the text, I can infer the following about the specific "performance data" mentioned:

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

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

• Test Set Sample Size: Not specified for the trocar compatibility test.
• Data Provenance: The study was an "In vitro (bench) test," meaning it was conducted in a laboratory setting, not on human subjects.

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

• Not applicable/not specified. The test was an in vitro bench test, implying objective measurements rather than expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. As an in vitro bench test, it would involve direct measurement and comparison to predefined thresholds, not expert adjudication.

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. This document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a surgical mesh, not an AI diagnostic tool.

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

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

7. The type of ground truth used:

• For the "trocar compatibility" test: The ground truth would likely be based on objective physical measurements and engineering specifications, determined by the manufacturer, rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical or diagnostic studies.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not a machine learning algorithm that would require a training set.

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

• Not applicable. No training set for an algorithm is mentioned.

Summary of the Study:

The primary study mentioned in this 510(k) summary is an in vitro (bench) test designed to evaluate the trocar compatibility of the Parietene™ Macroporous Mesh. The document states that "The results demonstrate that the subject device successfully met the established acceptance criteria and is substantially equivalent to the predicate device." No specific details about the methodology, sample size, or precise acceptance criteria for this bench test are provided in the excerpt. The substantial equivalence argument largely relies on the fact that "there is no change in the materials and manufacturing processes except in the instructions for use" compared to the predicate device.

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Symbotex™ Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.
ProGrip™ Self-Gripping Polyester Mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.
Parietex™ Hydrophilic 2D 3D Anatomical Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving inguinal and incisional hernia repairs.
Versatex™ Monofilament Mesh is intended for reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repairs.

The purpose of this Special 510(k) is to notify the Agency the changes made on Instructions for Use. There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices Symbotex™ Composite Mesh (K142908), ProGrip™ Self-Gripping Polyester Mesh (K142900), Parietex™ Hydrophilic 2D 3D Anatomical Mesh (K173796) and Versatex™ Monofilament Mesh (K150091).
Symbotex™ Composite Mesh is made out of a three-dimensional monofilament polyester textile which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Nonabsorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polvester textile flap is attached to the threedimensional reinforcement and helps place and fix the mesh.
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, positioning and fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps orientation.
The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
Two or three-dimensional multifilament polyester wall reinforcements.
The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach.
The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inquinal hernias, through open approach.
The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a pre-peritoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord.
The anatomical mesh is mainly designed for the repair of inquinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Versatex™ Monofilament Mesh is made of macroporous three-dimensional monofilament polyester textile. Largest sizes include a green dyed monofilament polyester (D&C Green No. 6) marking that is positioned in the center of the textile to help center and orient the mesh.

This document is a 510(k) summary for several surgical mesh products submitted to the FDA. The submission is not for a new device but rather to update the Instructions for Use (IFU) for existing, already cleared devices to comply with new European regulations and for general readability improvements. Therefore, there is no study described in this document that proves a device meets acceptance criteria related to clinical performance or effectiveness, as this is solely a labeling update submission.

The document explicitly states: "There is no change performed on the devices itself, and the device description is identical to those provided for predicate devices..." and "These modifications have no impact on the substantially equivalence between the subject devices and the predicate devices in terms of indications and design for the following technological characteristics: • Indications • Labelling (labels) • Design • Raw materials • Packaging • Biocompatibility • Stability • Sterilization".

However, the document does mention some performance data for trocar compatibility as part of continuous improvement initiatives related to the updated IFUs. This is a very specific type of bench test, not a clinical study on reader performance or standalone algorithm performance.

Here's a breakdown of what information can be extracted or inferred from the provided text, and what cannot based on the nature of this particular 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed performance results for the trocar compatibility test. It only states that the devices met the criteria.

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

• Test Set Sample Size: Not specified for the trocar compatibility bench test.
• Data Provenance: The document does not specify the country of origin for the bench test data. It is an in vitro (bench) test, not data from human subjects.

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

• Not applicable. The "ground truth" here pertains to the physical performance of the mesh with a trocar, which is evaluated through engineering/bench testing, not expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

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 MRMC study was done. This submission is for 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 standalone algorithm performance study was done. This submission is for surgical mesh, not an AI-powered device.

7. The type of ground truth used

• For the mentioned performance data (trocar compatibility): The ground truth would be the objective measurements and engineering standards applied during the in vitro bench testing.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm submission requiring training data.

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

• Not applicable. This is not an AI/algorithm submission requiring training data.

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Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.

Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.

This document describes the Dextile Anatomical Mesh, a surgical mesh intended for reinforcing soft tissues during inguinal hernia repair. The device is compared to a predicate device, the 3DMAX Light Mesh (K091659), to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document states that in vitro (bench) tests were performed in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999, to evaluate the performance characteristics of the subject device in comparison with the predicate. While specific numerical acceptance criteria or performance values are not provided in the document, the listed characteristics below were "assessed" and the overall conclusion is that the subject device is "substantially equivalent" to the predicate. This implies that the performance fell within acceptable limits or matched the predicate device for these parameters.

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 explicitly state the sample sizes for the various tests.

• In vitro (bench) tests: Implied to be performed by the manufacturer, Sofradim Production, which is based in France. No specific sample sizes mentioned for the mesh characteristics.
• Trocar passage testing: No specific sample size mentioned.
• In vivo pre-clinical tests: Conducted on a "representative animal model." The specific animal model and number of animals are not provided.
• Stability study: No specific sample size mentioned.
• Biocompatibility evaluation: No specific sample size mentioned, as this refers to compliance with a standard.
• Usability tests: No specific sample size or details of participants are given.

The provenance for tests performed by Sofradim Production would be France. The provenance of the animal model for in vivo testing is not specified.

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 device is a surgical mesh, not an AI or diagnostic device that requires expert interpretation for ground truth establishment in the typical sense (e.g., radiologists interpreting images). The "ground truth" for this device's acceptance criteria primarily relies on objective physical measurements, in vitro testing, animal study observations, and compliance with established biocompatibility and usability standards. Therefore, the concept of "experts establishing ground truth for a test set" as described in the prompt does not directly apply in the context of this traditional medical device submission. The FDA evaluates the submitted data and methodology to determine substantial equivalence.

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

Not applicable. As this is not an AI or diagnostic device submission involving human interpretation of data, there is no adjudication method used for a test set in this context. The evaluation is based on scientific testing and comparison to a predicate 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

Not applicable. This is a surgical mesh, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study was conducted.

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), not an algorithm or AI system.

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

For the Dextile Anatomical Mesh, the "ground truth" for establishing substantial equivalence and meeting acceptance criteria relies on:

• Objective quantitative measurements: For in vitro (bench) tests such as pore size, density, strength, elongation, etc. The "truth" is derived from calibrated measurement instruments.
• In vivo observations in animal models: For tissue integration, observed by qualified veterinary professionals or researchers.
• Compliance with recognized standards: Such as ISO Standard 10993-1 for biocompatibility.
• Functional demonstrations: Like the preservation of mesh integrity during trocar passage.
• Comparative analysis: Direct comparison of the subject device's characteristics and performance to those of the legally marketed predicate device (3DMAX Light Mesh K091659).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias.

Parietex™ Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The nonabsorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Optimized Composite Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable threedimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh: The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The three-dimensional mesh (TET references) has hexagonal pores. The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3-dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a preperitoneal or pre-muscular approach. The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique. The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord. The anatomical mesh is mainly designed for the repair of inguinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.

Parietex™ Composite Mesh is a composite mesh made out of a three-dimensional (3D) multifilament polyester textile for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the 3D reinforcement and helps place and fixate the mesh (PCO-OS references).

Parietex™ Optimized Composite Mesh is made out of a three-dimensional (3D) multifilament polyester for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol and juts out 5 mm over the edge of the reinforcement. The film is essentially degraded in less than 1 month. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fixates the mesh (PCO-OSX references). For some references, one or many non-absorbable color monofilaments are tied (pre-placed sutures) to the three-dimensional mesh (PCO-FX references).

This document is a 510(k) summary for a surgical mesh device, which describes its indications for use, device description, comparison to predicate devices, and performance data. However, it does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document describes a medical device clearance based on substantial equivalence to predicate devices, focusing on materials, design, and mechanical performance (bench testing) of surgical mesh. It explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means there was no clinical study, human-in-the-loop study, or AI/ML model performance evaluation described in this document.

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Duatene™ Bilayer Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the open repair of groin hernia defects.

Duatene™ Bilayer Mesh is designed to be placed in an extraperitoneal site by open approach. Duatene™ Bilayer Mesh is a three-dimensional device made out of polypropylene monofilament textile knitted in one-piece. The three-dimensional textile is composed of: a posterior textile layer which is circular or elliptic in shape (for preperitoneal placement); an anterior textile layer which is oblong in shape (for onlay placement). The two textile layers are designed with differentiated knitting patterns, adapted to the function of each layer. The two layers are linked by crossing threads from both textiles. The mesh is designed to be placed over the groin region to ensure long term reinforcement of soft tissues.

The provided text is a 510(k) summary for the Duatene™ Bilayer Mesh, a surgical mesh. This document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria for an AI/ML-based diagnostic or prognostic device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves a device meets those criteria for an AI/ML-based device. The original request is geared towards describing the validation of an algorithmic device (AI/ML), which this submission for a new surgical mesh does not cover.

To address the specific points in the request, based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. This document is about a material/surgical device, not an AI/ML performance. The "performance data" mentioned are for physical characteristics of the mesh (pore size, thickness, bursting strength, etc.) and biological compatibility, not AI/ML metrics like AUC, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical mesh samples used in bench tests or animal models, not a dataset of medical images or patient records for an AI/ML system. Data provenance is not specified in terms of patient origin.
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): Not applicable. Ground truth in this context would be laboratory measurements or pathological analysis from animal studies, not expert human interpretation for an AI/ML task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication of expert readers is relevant for AI/ML studies, not for the physical and biological testing of a surgical mesh.
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. There is no AI component involved; this is a traditional medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance would be established through laboratory measurements based on established standards (e.g., ISO Standard 10993-1 for biocompatibility, and "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" for mechanical properties), and histological evaluation in animal studies. It's not data based on expert consensus for diagnostic interpretation.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

The conclusion of the summary explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further indicates that the requested information for an AI/ML device's validation is not present. Instead, substantial equivalence was demonstrated through:

• In vitro (bench) tests comparing physical properties of the mesh to predicate devices.
• In vivo pre-clinical tests on representative animal models to evaluate tissue integration.
• Biocompatibility evaluation.
• Usability tests.

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Parietene™ DS Composite Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias or other abdominal fascial deficiencies that require the addition of a reinforcing material.

Parietene™ DS Composite Mesh is designed to be placed in an intraperitoneal site by a laparoscopic or open approach. The mesh is composed of a permanent macroporous polypropylene textile on one side and a fully absorbable synthetic film on the other side. The film is adhered to the textile using a binding agent localized on the textile fibers. A violet marking is positioned on the mesh to help center and orient the mesh. Non-absorbable preplaced sutures are tied to the mesh.

-The macroporous textile is knitted from a permanent monofilament polypropylene yarn.

• The synthetic film is made out of absorbable synthetic copolymer of glycolide, caprolactone, trimethylene carbonate, and lactide.

• The binding agent and the violet marking are made out of absorbable polycaprolactone. The D&C Violet No. 2 dye is used for the marking.

• The pre-placed sutures are made out of an isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin) and polyethylene. The Copper Phthalocyanine Blue is used to color the sutures.

The permanent macroporous textile is designed to be placed over the abdominal wall to ensure long term reinforcement of soft tissues, while the continuous absorbable film is designed to minimize tissue attachment to the mesh in case of direct contact with the viscera and is essentially degraded within 105 days by hydrolysis.

This document is a 510(k) premarket notification for the "Parietene™ DS Composite Mesh," a surgical mesh device. The available information does not include a description of acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML powered device, which your request implies. The device in question is a physical surgical mesh, and its evaluation is based on bench testing of physical properties, animal studies, and biocompatibility, not on AI/ML performance.

Therefore, many of the requested categories are not applicable to the provided document. I will fill in the applicable information based on the document's content.

Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance characteristic in the form of a pass/fail threshold. Instead, it states that in vitro tests were "performed in accordance with the 'Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh'" and conducted "in comparison with the predicate Proceed™ Surgical Mesh (K060713)." The implicit acceptance criterion is that the subject device's performance profiles are comparable to, or within acceptable limits of, the predicate device. Specific numerical results or "reported device performance" values are not provided in this summary, only the types of tests performed.

1. Sample sizes used for the test set and the data provenance:

• Test set sample sizes: Not specified in the document for any of the in vitro, in vivo, or usability tests.
• Data provenance:
  • In vitro (bench) tests: Performed in accordance with FDA guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" (1999).
  • In vivo pre-clinical tests: Conducted on "representative animal models." Specific country of origin for the animal studies is not mentioned, and they are prospective in nature for a pre-clinical evaluation.
  • Biocompatibility tests: Compliant with ISO Standard 10993-1.
  • Stability study: Conducted.
  • Usability tests: Conducted.
    The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This implies a lack of human clinical trial data.

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

• Not applicable. This device is a physical surgical mesh, not an AI/ML powered device requiring a "ground truth" established by experts in the context of diagnostic interpretation. The evaluation relies on standardized physical tests, animal studies, and regulatory standards.

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

• Not applicable. There is no mention of expert adjudication as this is not a diagnostic device.

4. 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. This is not an AI/ML powered device.

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

• Not applicable. This is not an AI/ML powered device.

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

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by:
  • Compliance with recognized standards (e.g., USP monograph for sutures, ISO 10993-1 for biocompatibility).
  • Comparability to a legally marketed predicate device (Proceed™ Surgical Mesh K060713) based on established in vitro and in vivo test methods commonly used for surgical meshes.

7. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

• Not applicable. This is not an AI/ML powered device.

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