(105 days)
LTM-BPS 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
LTM-BPS is intended for single patient, one time use only.
The LTM-BPS is a surgical mesh that is derived from porcine skin. The LTM-BPS 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 document is a 510(k) premarket notification for a medical device called "LTM-BPS Surgical Mesh." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a traditional acceptance criteria study. Therefore, the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not typically found in a 510(k) summary for this type of device.
Instead, the document highlights biocompatibility, viral inactivation, and biomechanical testing to support the safety and technological characteristics of the device.
Here's a breakdown of why specific information is missing and what is provided:
1. A table of acceptance criteria and the reported device performance:
- This information is not explicitly provided in the 510(k) summary. For device approvals based on substantial equivalence, the "acceptance criteria" are implicitly met if the device demonstrates equivalent performance characteristics (e.g., strength, biocompatibility) to predicate devices.
- The document states: "The biomechanical data show that the LTM-BPS matrix possesses sufficient strength and suture retention for the intended use." This is an overall statement of performance but does not list specific numerical criteria or outcomes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a 510(k) demonstrating substantial equivalence through non-clinical testing. The "test set" would refer to samples used for biocompatibility, animal, viral inactivation, and biomechanical testing. The exact number of samples for each of these tests is not quantified in the summary.
- The document states: "The LTM-BPS has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing." This indicates the types of tests performed.
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 as typically understood in a clinical study (e.g., disease presence/absence based on expert review) is not established here. The assessment of test results (e.g., biocompatibility) would be performed by qualified laboratory personnel following established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which is not the case for the testing 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:
- Not applicable. This device is a surgical mesh, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the traditional sense of a clinical study. For the non-clinical tests conducted, the "ground truth" would be established by validated testing methodologies and standards (e.g., ISO standards for biocompatibility).
8. The sample size for the training set:
- Not applicable. No training set is used as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. No training set is used.
§ 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.