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LTM-Perforated 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.

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

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital.

The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

The document is a 510(k) premarket notification for the LTM-Perforated Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device, LTM-Surgical Mesh (K070560), rather than providing acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic AI.

However, based on the provided text, I can extract information related to "acceptance criteria" (in this case, performance specifications for substantial equivalence) and the "study" (bench testing) used to support the claim.

Here's a breakdown of the requested information based on the document:

1. Table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria or performance values for the LTM-Perforated Surgical Mesh. Instead, it states that the device "maintains similar mechanical properties and meets the established specifications as the predicate device." The "acceptance criteria" are implied by the listed bench tests and the goal to be "substantially equivalent" to the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the sample size for the bench testing performed. It refers to "relevant elements" of the FDA guidance for test performance.
• Data Provenance: The bench testing was performed on the "subject LTM-Perforated Surgical Mesh device." It implies in-house testing by the manufacturer (LifeCell Corporation). The type of data is physical/mechanical test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device where expert assessment of "ground truth" (e.g., image interpretation) would be relevant. The "ground truth" for this device's performance is established by objective physical and mechanical tests against defined standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device requiring expert 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 a medical device (surgical mesh) and not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh) and not an AI algorithm.

7. The type of ground truth used

For the bench testing, the "ground truth" is established by:

• Objective physical and mechanical measurements.
• Adherence to recognized industry standards (ASTM D5735-95 for Tear Resistance, ASTM D6797-07 for Burst Strength).
• Comparison to the established performance specifications and characteristics of the legally marketed predicate device (LTM-Surgical Mesh K070560).
• Prior biocompatibility and viral inactivation data from the predicate device, which is deemed applicable due to identical raw materials and manufacturing processes (except for the perforations).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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