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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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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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Inguinal hernia repair via anterior tension-free approach.

The proposed ProGrip™ self-gripping polypropylene mesh is available in 2 forms;

• Pre-cut, elliptic mesh with slit and self-gripping, overlapping flap. Right or left anatomical side.
• Rectangular mesh.
  The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
  The subject modified ProGrip™ self-gripping polypropylene mesh is different from the predicate ProGrip™ self-gripping polypropylene mesh (K140941) in labeling and new sterilizer facilities with the same ethylene oxide method. There is no change to the technology, engineering, or material specifications.

This document is a 510(k) premarket notification for a medical device called "ProGrip Self-Gripping Polypropylene Mesh." The purpose of this submission is to demonstrate that the revised device is substantially equivalent to a legally marketed predicate device (K140941). The primary changes described are related to labeling updates and the addition of new sterilization facilities using the same ethylene oxide (EO) method.

Given this context, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/algorithm performance (e.g., impact on human readers, standalone performance, ground truth establishment, training set details) is not applicable to this specific submission.

Here's why, and what information can be extracted relevant to the submission:

Key Takeaway: This is a 510(k) for a physical medical device (surgical mesh), not an AI/Software as a Medical Device (SaMD). The "studies" conducted are non-clinical validations related to manufacturing processes, not diagnostic algorithm performance.

Therefore, I cannot provide the requested information for AI/algorithm performance. However, I can explain the acceptance criteria and supporting "studies" (validations) for this physical device:

Acceptance Criteria and Supporting Studies for ProGrip Self-Gripping Polypropylene Mesh (K220540)

This 510(k) submission primarily focuses on demonstrating that the changes made to the ProGrip Self-Gripping Polypropylene Mesh (labeling and new sterilization facilities) do not alter its substantial equivalence to the predicate device (K140941) regarding safety and effectiveness. The "acceptance criteria" here relate to maintaining established standards for sterilization, aeration, biocompatibility, and product performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as "sample size" in the context of a test set for diagnostic performance. Instead, validation studies were performed on product batches from the new sterilization sites. The specific number of units tested for sterilization, EtO residuals, and stability would be detailed in the underlying validation reports, but this summary document does not provide those specific numbers.
• Data Provenance: The data comes from internal validation studies conducted by Covidien/Medtronic, related to their manufacturing processes and new sterilization facilities. The location of these new facilities is not specified (e.g., country), but the general context is a US FDA submission. The studies are by nature prospective validations of the manufacturing and sterilization processes.

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

• Not Applicable. This is not an AI/diagnostic device. "Ground truth" in this context would relate to established standards (e.g., ISO for sterilization, biocompatibility, EtO residuals) and the qualifications of the engineers/scientists conducting the validation tests, not expert readers.

4. Adjudication method for the test set

• Not Applicable. This is not an AI/diagnostic device where adjudication of diagnostic outputs by multiple experts is relevant. Compliance with standards is demonstrated through test results.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• Not Applicable. This is not an AI/diagnostic device, so MRMC studies comparing human reader performance are irrelevant.

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

• Not Applicable. This is a physical surgical mesh, not an algorithm.

7. The type of ground truth used

• Regulatory/Engineering Standards: The "ground truth" for this submission is adherence to established regulatory and engineering standards (e.g., ISO 10993-1 for biocompatibility, ISO 10993-7 for EtO residuals), and internal quality system validation protocols for sterilization and product performance. The predicate device (K140941) also serves as a benchmark for equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical surgical mesh, not an AI/machine learning model, so there is no "training set."

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

• Not Applicable. See #8.

In summary, the provided document is a regulatory submission for a physical medical device. The "acceptance criteria" and "studies" it references are related to demonstrating the continued safety and effectiveness of the device despite manufacturing and labeling changes, primarily through non-clinical validation testing against established industry and regulatory standards.

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PROGRIP™ Self-Gripping Polypropylene Mesh is intended for the reinforcement of tissue during surgical repair.
Parietene™ Flat Sheet Mesh is intended for the reinforcement of tissue during surgical repair.
PROGRIP™ Self-Gripping Polypropylene Mesh is indicated for inguinal and incisional hernia repair.
Parietene™ Flat Sheet Mesh is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.

PROGRIP™ Self-Gripping Polypropylene Mesh: The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polypropylene with polylactic acid monofilament resorbable hooks on one of the sides. These hooks facilitate placing, positioning and temporary fixation of the overlapping flap and the mesh to the surrounding tissue. A colored yarn marker is placed on the medial edge of the pre-cut mesh to help with orientation.
Parietene™ Flat Sheet Mesh: Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.

The provided text describes a 510(k) submission for two surgical mesh devices, PROGRIP™ Self-Gripping Polypropylene Mesh and Parietene™ Flat Sheet Mesh. The submission seeks to add a new formulation of raw material (polypropylene) from the same yarn supplier.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The results of the bench and preclinical tests demonstrate that proposed devices are substantially equivalent to the predicates Parietene™ PROGRIP Mesh (K101197) and Parietene™ Polypropylene Mesh (K991400)." This implies that the device met the acceptance criteria by demonstrating substantial equivalence through various tests.

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

The document does not explicitly state the sample size used for the test set of the performance studies. It mentions "bench testing" and "preclinical tests." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies mentioned are bench and preclinical tests, which typically do not involve expert interpretation for ground truth in the same way clinical image analysis studies would.

4. Adjudication Method for the Test Set

This information is not provided as the studies are bench and preclinical tests, not clinical studies requiring adjudication of output.

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 conducted or mentioned. This submission is for a surgical mesh, not an AI-powered diagnostic or assistive device.

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

Not applicable, as this is a physical medical device (surgical mesh), not an algorithm or AI system. The performance studies are focused on the material properties and biocompatibility of the mesh.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be established through standard engineering and materials science measurements, comparing the new material's performance to established specifications or the predicate devices' performance.

For biocompatibility, the ground truth would be established through standard cytotoxicity, sensitization, irritation, etc., testing as per ISO 10993-1, determining if the material elicits an unacceptable biological response.

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 concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical surgical mesh device.

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