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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.

L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289).

The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.

The provided text describes a 510(k) premarket notification for a medical device called LTM-Laparoscopic Surgical Mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria in the typical sense of measuring performance against predefined metrics (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Here's an analysis based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:

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

For this type of device (surgical mesh) and submission (510(k) for a minor modification), acceptance criteria are primarily related to safety and efficacy not being negatively impacted by the change, and the device continuing to perform its intended use. The "performance" reported is less about statistical metrics and more about confirming functionality under the new condition.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text describes "testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions." However, it does not specify:

• The sample size of the test set (e.g., number of meshes tested, number of fixation points).
• Data provenance (country of origin), although it's a submission to the US FDA.
• Whether the study was retrospective or prospective, but "simulated conditions" implies a controlled experimental setup.

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 type of information is not applicable to the study described. The study involves a physical device and its fixation method, not an AI or diagnostic tool requiring expert interpretation for ground truth establishment.

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

Not applicable. This is not an observational study requiring adjudication of expert opinions. The "results have demonstrated" implies objective measurements or observations in the simulated conditions, rather than subjective interpretation that would need 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

Not applicable. This is not an AI/diagnostic device, and no MRMC study was performed.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is implied to be the successful and safe fixation of the mesh under simulated conditions, and the maintenance of the device's intended function. It's based on technical assessment and potentially engineering testing rather than medical "ground truth" like pathology or clinical outcomes in patients for this specific modification.

8. The sample size for the training set

Not applicable. There is no training set for this type of device modification.

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

Not applicable. There is no training set.

Summary of the Study:

The study described is a design validation testing for a minor modification to the Instructions for Use of LTM-Laparoscopic Surgical Mesh. The modification allows for fixation of the mesh using surgical tacks in addition to sutures.

• Objective: To ensure that using surgical tacks for fixation does not negatively impact the safety and efficacy of the device.
• Methodology: Laparoscopic fixation of the mesh using surgical tacks was performed under "simulated conditions."
• Findings: The results "demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."
• Conclusion: The device continues to perform its intended use and is substantially equivalent to the predicate device.

This submission is a 510(k), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials, especially for minor modifications like this one. The "study" here is a targeted engineering/performance test to address the specific change.

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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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