(104 days)
LTM Surgical Mesh (LTM) 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.
LTM is intended for single patient use only.
The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.
The provided text describes a 510(k) premarket notification for the LTM Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through a detailed study with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving device performance as typically expected for an AI/device performance study.
Here's a breakdown of why this information is not present and what is stated instead:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in this context. The 510(k) summary focuses on demonstrating substantial equivalence, not on meeting specific, quantifiable acceptance criteria for a novel performance characteristic.
- What is reported: "The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use." This is a general statement, not a table of specific criteria and results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not discussed. There is no mention of a "test set" in the context of clinical or performance data for software or AI. The performance data mentioned refers to lab-based biocompatibility, animal testing, viral inactivation, and biomechanical testing.
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):
- Not Applicable. Ground truth in the context of expert consensus is not a component of this submission. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for performance validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for studies where human interpretation of results (e.g., medical images) is involved to establish ground truth or resolve discrepancies. This is not the case for a surgical mesh.
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. MRMC studies and the concept of "human readers improving with AI" are specific to AI-powered diagnostic or assistive devices. The LTM Surgical Mesh is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to AI algorithm performance, which is not relevant to a surgical mesh.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the typical sense. For the performance data cited (biocompatibility, animal testing, viral inactivation, biomechanical testing), the "ground truth" would be established by scientific and laboratory standards, validated assays, and accepted engineering principles for material strength. It's not a diagnostic "ground truth" as you'd define for an AI system.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this device is not an AI/machine learning algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. As there's no training set, there's no ground truth to establish for it.
Summary of Device Performance as Stated in the 510(k) Document:
The LTM Surgical Mesh's performance is demonstrated through:
- Extensive biocompatibility testing: Indicates the device is safe for biological interaction.
- Animal testing: Used to assess in-vivo performance and safety.
- Viral inactivation testing: Proves the manufacturing process effectively eliminates viral components from the porcine source material.
- Biomechanical testing: Shows the LTM matrix has "sufficient strength and suture retention for the intended use."
The entire submission hinges on demonstrating substantial equivalence to existing predicate devices (Permacol® Implant and Surgisis®) based on:
- Same intended uses and similar indications.
- Same or similar technological characteristics (derived from porcine skin, terminally sterilized sheet of processed dermal matrix).
- Similar principles of operation.
The statement explicitly says: "Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent." This is the core "proof" in a 510(k) for this type of device, rather than meeting specific, numerical acceptance criteria for novel performance claims.
§ 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.