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

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

3DMatrix DynaFlex ("DynaFlex") is a single-use, fully absorbable, colorless, non-woven, 3D-printed, macroporous, polymeric surgical mesh made entirely of uncolored and undyed polydioxanone (PDO). DynaFlex is provided in three sizes, 6 cm x 5.5 cm, 6 cm x 14.5 cm, and 5 cm x 17 cm, that can be cut to the desired shape and size for each specific application at the time of use. DynaFlex is terminally sterilized by Ethylene Oxide validated to an SAL of 10-6 and intended to be used by prescription only in a healthcare facility or hospital.

Once implanted, DynaFlex 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. DynaFlex provides temporary mechanical support and stabilization during the healing process. DynaFlex mesh is not isotropic so the mechanical properties of DynaFlex mesh are direction dependent.

The provided FDA 510(k) Clearance Letter for the 3DMatrix DynaFlex (DynaFlex) surgical mesh does not describe a study involving AI-driven diagnostic or assistive technology that would require ground truth adjudication, multi-reader multi-case studies, or specific acceptance criteria for a classification or regression task.

Instead, this document details the substantial equivalence of a medical device (a surgical mesh) to its predicate devices based on non-clinical performance and material characteristics. The "acceptance criteria" and "study proving the device meets acceptance criteria" here refer to the physical and biological properties of the surgical mesh as compared to a previously cleared device, not the performance of a software algorithm.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device clearance.

Below, I will present the information that is available in the provided text, reinterpreting the "acceptance criteria" and "study" in the context of a physical medical device.

Device Description and Intended Use

• Device Name: 3DMatrix DynaFlex (DynaFlex)
• Device Type: Surgical Mesh
• Intended Use: Reinforcement of soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. Examples include suture line reinforcement (including for hernia repair), muscle flap reinforcement, and general tissue reconstructions.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a predicate device (3DMatrix Surgical Mesh, K232602) and several reference devices, based on various non-clinical tests. The performance is reported in terms of equivalence to or comparison with these predicate/reference devices.

Table 1: Acceptance Criteria (as demonstrated through equivalence) and Reported Device Performance

Study Proving the Device Meets Acceptance Criteria

The study conducted was a non-clinical performance evaluation to demonstrate substantial equivalence to legally marketed predicate and reference devices.

1. Sample Size Used for the Test Set and Data Provenance:

   • This inquiry is relevant for studies involving patient data or images (e.g., AI/Dx devices). For a physical medical device like a surgical mesh, "test set" refers to the samples of the device itself undergoing various physical and chemical tests. The document does not specify the exact number of samples used for each test (e.g., number of mesh pieces tested for tensile strength or degradation).
   • Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory and biocompatibility testing of the manufactured mesh samples.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • This is not applicable as the "ground truth" for a surgical mesh involves standardized physical, chemical, and biological testing methods (e.g., ASTM standards, ISO 10993). While experts design and interpret these tests, there isn't a "consensus" process like for annotating medical images.

3. Adjudication Method for the Test Set:

   • Not applicable. This is a concept for reconciling disagreements in human annotations for AI/Dx ground truth.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This type of study is for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No. This is an AI/software performance metric, not relevant for a physical surgical mesh.

6. The Type of Ground Truth Used:

   • The "ground truth" for this device's performance is established through standardized non-clinical laboratory testing (e.g., tensile strength, tear strength, burst strength, degradation rates, biocompatibility) according to recognized international and industry standards (e.g., ASTM D6797-15, ASTM D2261-13, ASTM D5035-11, ISO 10993-1). This includes in vitro and in vivo (animal) biocompatibility studies.

7. The Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable.

Summary of Non-Clinical Tests

The non-clinical tests performed to demonstrate substantial equivalence covered:

• Mechanical Performance:
  • Ball Burst Strength/Force (ASTM D6797-15)
  • Suture Pull-Out Strength (Internal Test Method)
  • Tear Strength (ASTM D2261-13)
  • Tensile Strength (ASTM D5035-11)
• Degradation:
  • Mechanical degradation kinetics
  • Mass degradation kinetics
• Bioabsorption:
  • In vivo bioabsorption
• Biocompatibility:
  • All endpoints required for long-term implant devices with tissue and bone, in accordance with ISO 10993-1, including hemolysis. These studies were conducted in compliance with GLP regulations (21 CFR Part 58) and FDA Guidance for Use of ISO 10993-1.

The conclusion drawn from these non-clinical tests was that the DynaFlex device is substantially equivalent to its predicate and reference devices in terms of intended/indications for use, design, materials, function, biocompatibility, and sterilization, and performs as well as them.

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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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