(215 days)
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
| Characteristic / Acceptance Criteria via Equivalence | Predicate – 3DMatrix | Reference Device Parameters (where applicable) | Subject Device – DynaFlex Reported Performance |
|---|---|---|---|
| Indications for Use/Intended Use | Same | Equivalent | Identical to predicate & equivalent to reference devices |
| Material | Polydioxanone (PDO) | Polyglycolic acid (PGA): Trimethylene carbonate (TMC), Polypropylene, Poliglecaprone25 | Identical to predicate (Polydioxanone (PDO)) |
| Use | Single Use | Single Use | Identical to predicate & reference devices |
| Sterilization Mode & SAL | Ethylene Oxide SAL 10-6 | Gamma SAL 10-6, Ethylene Oxide SAL 10-6 | Identical to predicate & equivalent to references |
| Biodegradable | Yes | Yes (K163217), No (K052155), Partial (K033337) | Identical to predicate & equivalent to K163217 |
| Primary Mechanism of Degradation | Hydrolysis | Hydrolysis | Identical to predicate & equivalent to K163217 |
| Biocompatible | Yes | Yes | Identical or better than predicate & equivalent to reference devices |
| Packaging | Double-layer Tyvek and polyethylene pouch, sealed in foil | Diverse (Tyvek-Film, cardboard box) | Identical to predicate & equivalent to K163217 |
| Bioabsorption Timeframe | 6-7 months | 6-7 months (K163217), 84 days (K033337 component) | Identical to predicate & equivalent to K163217 |
| Storage Conditions | Room Temperature | Room Temperature, No special storage | Identical to predicate & equivalent to K163217 |
| Shape | Rectangular | Rectangular, Square, Various Shapes | Equivalent to predicate & reference devices |
| Pore Size (mm²) | 1.21 | Microporous, 6.29, 3.4 | 7.5 ± 0.2 (Equivalent to reference K052155) |
| Density (g/m²) | 392 | 43.7, 34 | 289 (Difference does not raise questions) |
| Bi-Directional Mechanics (Load Bearing) | No | Yes (K052155, K033337) | Yes (Equivalent to reference devices) |
| Mechanical Performance (Key Metrics) | Equivalent | Not directly compared, implied | Substantially equivalent in ball burst strength, suture pull-out strength, tear strength, and tensile strength to predicate. |
| Mechanical/Mass Degradation Kinetics | Equivalent | Not directly compared, implied | Substantially equivalent to predicate. |
| In Vivo Bioabsorption | Equivalent | Not directly compared, implied | Substantially equivalent to predicate. |
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.
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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.
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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.
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Adjudication Method for the Test Set:
- Not applicable. This is a concept for reconciling disagreements in human annotations for AI/Dx ground truth.
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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.
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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.
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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.
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The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
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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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.