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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 Composix™ L/P Mesh with Echo PSTM Positioning System is comprised of a hernia repair mesh with a pre-attached mesh positioning system (mesh deployment balloon). The mesh, Composix™ L/P, is a low profile, nonabsorbable, sterile prosthesis designed for the reconstruction of soft tissue deficiencies, previously cleared under K061754. It is constructed of one layer of large pore polypropylene mesh and one layer of expanded polytetrafluoroethylene (ePTFE) stitched together with PTFE monofilament. The Composix™ L/P Mesh described above will be preassembled with the Echo PSTM Positioning System, a removable mesh deployment balloon, previously cleared under K092726. The positioning system is designed to help facilitate laparoscopic deployment, including unrolling, positioning, and placement of the Composix™ L/P Mesh. Additionally, all sizes of the proposed product will be packaged with an Introducer Tool. The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll the proposed device in order to facilitate laparoscopic introduction. The Introducer Tool is identical to that included and cleared under the Composix® L/P Mesh K061754.

The provided 510(k) summary (K102766) describes a medical device, the Composix™ L/P Mesh with Echo PSTM Positioning System, which is a combination of two previously cleared devices. It is important to note that this submission is for a combination device and relies heavily on the substantial equivalence to its predicate devices rather than a de novo study demonstrating novel performance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a numerical sample size for a "test set" in the context of a clinical performance study. The studies mentioned are:

• Biocompatibility testing: Conducted on the proposed device (mesh and positioning system).
• Bench testing: Conducted on the proposed device design.
• In vivo simulated use experiments: Conducted on the proposed device design.

The nature of these tests suggests they are laboratory or animal-based, not human clinical trials with a specific "test set" of patients.

Data Provenance: The data provenance is not specified in terms of country of origin or retrospective/prospective. Given the type of tests described (bench, in vivo simulated use), it is safe to assume these are prospective experiments/tests conducted for the purpose of this submission, likely within a laboratory or controlled setting.

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 performed (biocompatibility, bench, in vivo simulated use) do not typically involve human expert "ground truthing" in the way a diagnostic AI device would. The "ground truth" for material biocompatibility is based on ISO standards, and for functional performance, it's against design specifications and intended use.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the described studies are not clinical trials or diagnostic performance studies that would involve expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh system, not an AI-assisted diagnostic tool where human readers would assess images with and without AI assistance. The document focuses on the physical and functional performance of the medical device itself and its equivalency to existing products.

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 and deployment system), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• International Standards: For biocompatibility (ISO 10993-1, ASTM F899-09e1).
• Product Specifications: For bench testing and in vivo simulated use experiments, the device performance is measured against pre-defined product specifications and intended use requirements.
• Predicate Device Performance/Characteristics: A significant part of the "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable/provided as there is no training set for this type of medical device submission.

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The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.

The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.

The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.

This 510(k) summary is for a medical device (SURGIMESH®XB surgical mesh) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.

Here's an attempt to address the points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

Acceptance Criteria and Study for SURGIMESH®XB

The submission for SURGIMESH®XB is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) in the same way an AI diagnostic algorithm would, nor does it present a clinical trial with a test set, ground truth experts, or MRMC studies.

Therefore, the "acceptance criteria" for a device like SURGIMESH®XB are implicitly tied to demonstrating that its mechanical, material, and biocompatibility characteristics are "substantially equivalent" to predicate devices, which are themselves deemed safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not Applicable. This submission does not describe a clinical "test set" in the context of diagnostic performance. The evaluation is based on material testing and comparison to predicates.
• Data Provenance: Not Applicable. No patient data or clinical study dataset is described.

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

• Number of Experts: Not Applicable. No ground truth establishment by experts is described for this type of device submission.
• Qualifications of Experts: Not Applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not Applicable. No test set requiring expert adjudication is described.

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

• MRMC Study: No. This is a surgical mesh, not an AI diagnostic device for human readers.
• Effect Size: Not Applicable.

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

• Standalone Performance: Not Applicable. This is a surgical mesh, not an algorithm.

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

• Type of Ground Truth: Not Applicable. The "ground truth" concept for a surgical mesh revolves around proven safety and effectiveness of similar devices and the demonstration of equivalent physical, mechanical, and biological properties. It's not based on case-level diagnoses or outcomes in a study, but rather on material science and biocompatibility testing.

8. The Sample Size for the Training Set

• Sample Size: Not Applicable. This is a surgical mesh, not an AI device that uses a training set.

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

• Ground Truth Establishment: Not Applicable.

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