(23 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fixation using surgical tacks does not affect safety and efficacy. | "Testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions, and the results have demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy." |
| Device continues to perform its intended use. | "Thus, the proposed LTM-Laparoscopic Surgical Mesh continues to perform its intended use as a soft tissue patch to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes and is substantially equivalent to the predicate device LTM-Laparoscopic Surgical Mesh (K121289)." |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.