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LTM-Laparoscopic Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.

LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.

The document describes the LTM-Laparoscopic Surgical Mesh, a device intended for surgical repair of hernias and body wall defects. The submission focuses on demonstrating substantial equivalence to a predicate device, LTM Surgical Mesh (K070560), and discusses its performance relative to established specifications.

Here's an analysis of the provided information, structured according to your request:

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 the numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing" of the predicate device (K070560). For the LTM-Laparoscopic Surgical Mesh itself, it states that it "went through the same biomechanical testing after laparoscopic handling (Attachment 1)."

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 study primarily relies on physical and manufacturing consistency with a previously cleared device and biomechanical testing, rather than expert evaluation of the device in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study focuses on physical and mechanical properties rather than subjective assessments requiring 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

An MRMC study was not done. This device is a surgical mesh, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

A standalone performance study of an algorithm was not done. This is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through biomechanical specifications and performance data derived from the predicate device (LTM Surgical Mesh K070560) and further confirmed through specific tests on the LTM-Laparoscopic Surgical Mesh after simulated laparoscopic handling. This includes:

• Tensile Strength
• Tear Resistance
• Suture Pull-out Strength
• Burst Strength
• Biocompatibility data (from predicate)
• Viral inactivation data (from predicate)

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as it concerns a physical surgical device, not a machine learning algorithm.

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

This information is not applicable as there is no training set for a machine learning algorithm.

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The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.

The SURGIMESH®XB-Skirted is indicated for 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 - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted 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. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.

More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).

This document describes the premarket notification 510(k) for the SURGIMESH®XB - Skirted surgical mesh. The provided text outlines the device's characteristics, intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a specific set of acceptance criteria with human readers or standalone algorithm performance.

Here's an analysis of the available information regarding acceptance criteria and supporting studies, formatted as requested, and noting where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "Preclinical testing was conducted" but does not detail the number of units or samples tested for each criterion.
• Data Provenance: The studies were preclinical testing conducted by Aspide Medical. The location of these tests (e.g., country of origin) is not explicitly stated, but Aspide Medical is based in LA TALAUDIERE (FRANCE). The studies are retrospective as they summarize testing that has already been performed.

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

This information is not applicable to the provided document. The performance data focuses on technical and material characteristics of a surgical mesh, not on expert interpretations of medical images or clinical outcomes that typically require ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The reported tests are objective technical validations against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This document describes a medical device (surgical mesh), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.

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

This information is not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.

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

The "ground truth" for the performance testing cited are the established international standards (ISO, USP) for biocompatibility, sterility, packaging, and material characterization. The device's performance was compared against these universally recognized technical standards and against the specifications of predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a medical device (surgical mesh) testing and substantial equivalence, not the development or training of an AI model that would require a training set.

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

This information is not applicable. As no AI model or training set is mentioned, there is no ground truth for a training set to be established.

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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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