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3DMatrix is indicated for the reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples of applications where 3DMatrix may be used include:

• Suture line reinforcement including for hernia repair
• Muscle flap reinforcement
• General tissue reconstructions

3DMatrix Surgical Mesh (3DMatrix) is a single-use, fully absorbable, colorless, non-woven, 3Dprinted, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). 3DMatrix is provided in two sizes, 60 mm x 55 mm and 60 mm x 145 mm that can be cut to the desired shape and size for each specific application at the time of use. 3DMatrix is terminally sterilized by Ethylene Oxide validated to an SAL of 10- and intended to be used by prescription only in a healthcare facility or hospital.

3DMatrix is a medical device used for surgical repair or reinforcement of soft tissue. Once implanted, 3DMatrix acts as a mechanical support to soft tissues and provides a scaffold for tissue ingrowth. It is designed to fully degrade over six to seven months. 3DMatrix provides temporary mechanical support and stabilization during the healing process.

The provided text describes a 510(k) summary for the 3DMatrix Surgical Mesh but does not specify acceptance criteria or a detailed study proving the device meets those criteria with specific performance metrics against defined thresholds. Instead, it presents a comparison to predicate devices and states that performance characteristics were "substantially equivalent."

Here's an analysis based on the information provided, highlighting what's available and what's missing:

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

The document doesn't explicitly state quantitative acceptance criteria for the 3DMatrix Surgical Mesh in terms of specific thresholds for strength, adhesion, degradation rate, etc. It focuses on demonstrating "substantial equivalence" to predicate devices, meaning the performance is comparable rather than meeting pre-defined numerical targets.

However, it does list several performance characteristics that were tested and compared, suggesting these were the implicit criteria for equivalence. The table below represents what can be inferred from the "SUMMARY OF PERFORMANCE DATA" section, but without explicit acceptance criteria, specific reported performance values for 3DMatrix, or performance values for the predicate device, a complete table cannot be generated from the provided text.

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

• Sample Size: Not specified for any of the performance tests (benchtop or animal studies).
• Data Provenance: The document only mentions "benchtop and animal studies." It does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not applicable as the device is a surgical mesh and the studies conducted are focused on physical and biological performance, not on image interpretation or diagnostic accuracy that would require expert consensus for ground truth.

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

This information is not applicable for the type of device and studies described. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images).

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:

This information is not applicable as the device is a surgical mesh, not an AI software or an assistive technology for human readers.

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

This information is not applicable as the device is a surgical mesh, not an algorithm.

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

For the performance data, the "ground truth" would be established by the standardized test methods for material properties (e.g., ASTM standards) and validated biological testing protocols (e.g., ISO 10993-1). For the animal studies, histological examination or other biological assessments would constitute the ground truth for biocompatibility and tissue ingrowth. The document generally states "biocompatibility studies" and "animal studies" without specific ground truth details.

8. The sample size for the training set:

This information is not applicable as the device is a physical surgical mesh, not a machine learning model.

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

This information is not applicable for the same reason as above.

In summary, the provided text is a regulatory submission for a physical medical device (surgical mesh). It demonstrates equivalence to predicate devices through various benchtop and animal studies evaluating physical properties and biocompatibility. However, it lacks specific quantitative acceptance criteria and detailed performance metrics for the 3DMatrix beyond stating "substantial equivalence" to its predicates. The types of questions related to expert consensus, adjudication, and AI performance are not relevant to this specific device submission.

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PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

PROCEED* Surgical Mesh is a sterile mesh designed for the repair of hernias and other fascial deficiencies. The mesh product has separate layers comprising of PROLENE* Soft Mesh, a nonabsorbable polypropylene mesh, a fabric of oxidized regenerated cellulose (ORC) and a polydioxanone polymer film.

Acceptance Criteria and Device Performance Study for PROCEED* Trilaminate Surgical Mesh

The provided document describes the predicate equivalence of the PROCEED* Trilaminate Surgical Mesh. The nature of this submission (a 510(k) for a medical device) means that the "acceptance criteria" are primarily related to demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance metrics with predefined thresholds like a diagnostic AI model.

The study presented focuses entirely on non-clinical laboratory and in-vivo animal testing to demonstrate comparability and intended performance. It does not involve human readers, AI algorithms, or clinical trials with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies non-clinical laboratory testing and in-vivo testing.

• Sample size for test set: Not explicitly stated. The nature of the non-clinical lab and in-vivo testing (which implies animal studies in this context) would typically involve specific numbers of samples or animals, but these are not provided in this summary.
• Data provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would primarily be generated by the manufacturer (Ethicon, Inc.) through their own testing facilities or contracted labs. The "in-vivo testing" suggests animal studies were conducted. It is retrospective in the sense that the testing was completed before the submission.

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

This question is not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. The "ground truth" for a surgical mesh device would be derived from physical property measurements and biological responses in animal models, not expert interpretations of data.

4. Adjudication method for the test set

This question is not applicable. There is no adjudication method described as the study does not involve human interpretation or consensus for a test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a surgical mesh and does not involve AI assistance, human readers, or diagnostic performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This study is for a surgical mesh and does not involve any algorithms or AI.

7. The type of ground truth used

The ground truth used for this type of device would be:

• Benchtop Data: Physical and mechanical properties of the mesh (e.g., tensile strength, pore size, burst strength, pliability) compared to predicate devices and engineering specifications.
• In-vivo (Animal) Data: Biological response and performance in animal models (e.g., tissue integration, adhesion formation, inflammatory response, degradation profile, functional outcome related to hernia repair).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a non-AI surgical device. All testing described falls under verification and validation activities.

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

This question is not applicable, as there is no training set mentioned or implied by the type of device and study.

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