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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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Dextile™ Anatomical Mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernia by laparoscopic approach.

Dextile™ Anatomical Mesh is designed to be placed in a pre-peritoneal site by laparoscopic approach. The device has an anatomical shape with sealed edges allowing coverage of inguinal hernia defects and facilitating laparoscopic mesh deployment and handling. The mesh is made of a non-absorbable macroporous monofilament polypropylene textile. A green marking is placed on the medial side of the mesh to help positioning and orienting the mesh: "ML" letters designate Medial Line. The green marking is made of monofilament polyester yarn. The "D&C Green No. 6" dye is used for the marking.

This document describes the Dextile Anatomical Mesh, a surgical mesh intended for reinforcing soft tissues during inguinal hernia repair. The device is compared to a predicate device, the 3DMAX Light Mesh (K091659), to demonstrate substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

The document states that in vitro (bench) tests were performed in accordance with the FDA Guidance "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" issued March 2, 1999, to evaluate the performance characteristics of the subject device in comparison with the predicate. While specific numerical acceptance criteria or performance values are not provided in the document, the listed characteristics below were "assessed" and the overall conclusion is that the subject device is "substantially equivalent" to the predicate. This implies that the performance fell within acceptable limits or matched the predicate device for these parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the various tests.

• In vitro (bench) tests: Implied to be performed by the manufacturer, Sofradim Production, which is based in France. No specific sample sizes mentioned for the mesh characteristics.
• Trocar passage testing: No specific sample size mentioned.
• In vivo pre-clinical tests: Conducted on a "representative animal model." The specific animal model and number of animals are not provided.
• Stability study: No specific sample size mentioned.
• Biocompatibility evaluation: No specific sample size mentioned, as this refers to compliance with a standard.
• Usability tests: No specific sample size or details of participants are given.

The provenance for tests performed by Sofradim Production would be France. The provenance of the animal model for in vivo testing is not specified.

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 device is a surgical mesh, not an AI or diagnostic device that requires expert interpretation for ground truth establishment in the typical sense (e.g., radiologists interpreting images). The "ground truth" for this device's acceptance criteria primarily relies on objective physical measurements, in vitro testing, animal study observations, and compliance with established biocompatibility and usability standards. Therefore, the concept of "experts establishing ground truth for a test set" as described in the prompt does not directly apply in the context of this traditional medical device submission. The FDA evaluates the submitted data and methodology to determine substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is not an AI or diagnostic device submission involving human interpretation of data, there is no adjudication method used for a test set in this context. The evaluation is based on scientific testing and comparison to a predicate device.

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 surgical mesh, not an AI-assisted diagnostic or interpretation device. Therefore, no MRMC study was conducted.

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

Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the Dextile Anatomical Mesh, the "ground truth" for establishing substantial equivalence and meeting acceptance criteria relies on:

• Objective quantitative measurements: For in vitro (bench) tests such as pore size, density, strength, elongation, etc. The "truth" is derived from calibrated measurement instruments.
• In vivo observations in animal models: For tissue integration, observed by qualified veterinary professionals or researchers.
• Compliance with recognized standards: Such as ISO Standard 10993-1 for biocompatibility.
• Functional demonstrations: Like the preservation of mesh integrity during trocar passage.
• Comparative analysis: Direct comparison of the subject device's characteristics and performance to those of the legally marketed predicate device (3DMAX Light Mesh K091659).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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