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The 3DMax™ MID Anatomical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists, in the repair of inguinal hernias.

3DMax™ MID Anatomical Mesh is a sterile, single-use device for prescription use only. It is made from the identical macroporous polypropylene mesh as the secondary predicate device (VITAMESH™ MacroPorous PP Surgical Mesh, K172636) monofilament polypropylene and has an open pore design with a 3-dimensional curve and preformed, semi-rigid edges based on the design of the primary predicate 3DMax™ Light (K091659). The orientation markings help to determine the orientation and position of the 3DMax™ MID Anatomical Mesh with regards to groin anatomy. The subject device has the identical intended use as the primary and predicate devices; soft tissue repair/reinforcement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3DMax™ MID Anatomical Mesh, structured according to your request.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies heavily on comparisons to existing devices and performance testing rather than new clinical trials for safety and effectiveness, especially for Class II devices like surgical mesh. Therefore, many of the requested elements (like MRMC studies, large training sets, expert consensus for ground truth in clinical data) are not applicable in this context, as the device is not an AI/ML algorithm or a diagnostic tool that requires such rigorous clinical validation in its 510(k) submission.

Summary of Device and Context:

The 3DMax™ MID Anatomical Mesh is a sterile, single-use surgical mesh indicated for the reinforcement of soft tissue in the repair of inguinal hernias. It is a Class II device. The submission aims to prove substantial equivalence to two predicate devices: 3DMax™ Light (K091659) and VITAMESH™ MacroPorous PP Surgical Mesh (K172636).

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not framed as specific performance metrics derived from a clinical study comparing the AI to a ground truth, but rather as meeting predefined engineering and biocompatibility standards, and demonstrating comparability to predicate devices. The "reported device performance" is the successful passing of these tests.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of an AI/ML device or a comparative clinical study for this 510(k) submission. The "test set" here refers to physical mesh samples used for bench testing.

• Sample Size for Bench Testing: The document does not specify the exact number of mesh samples used for each bench test (e.g., how many meshes were tested for tensile strength).
• Data Provenance: The testing was conducted internally by the manufacturer (C.R. Bard, Inc./Davol, Inc.) or by contract labs. The data is from prospective bench testing performed specifically for this submission. The country of origin for the data is implicitly the USA (company location in Rhode Island).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable. For a surgical mesh 510(k) submission, "ground truth" is established through engineering specifications, biocompatibility standards (e.g., ISO 10993-1), and FDA guidance for substantial equivalence. There are no "experts" in the sense of clinicians establishing a "ground truth" for a test set of patient data, as no clinical efficacy study was performed.

4. Adjudication Method for the Test Set

This is not applicable. There is no clinical test set requiring adjudication in this submission. Bench test results are objectively measured against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, especially those incorporating AI, to assess the impact of the AI on human reader performance. For a surgical mesh, the focus is on physical properties and biocompatibility, not diagnostic performance.

Therefore, there is no effect size of human readers improving with AI assistance vs. without AI assistance to report.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone performance study was not done. This device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established engineering specifications and material standards: These define what constitutes acceptable performance for properties like tensile strength, pore size, etc.
• Biocompatibility standards: Primarily ISO 10993-1, which guides the biological evaluation of medical devices.
• Regulatory precedent: The performance and safety profiles of the predicate devices (3DMax™ Light and VITAMESH™ MacroPorous PP Surgical Mesh) serve as the benchmark for substantial equivalence.
• Histological evaluation: An animal study on the original polypropylene mesh (from the secondary predicate) established "ground truth" regarding host inflammatory/fibrotic response in a rabbit model.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The phrase "training set" usually refers to data used to train a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set.

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