(269 days)
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.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Specificity NOT available in document) |
|---|---|
| Biocompatibility (compliance with ISO 10993-1) | Met (conducted in compliance with GLP and ISO 10993-1) |
| Performance in terms of: | |
| - Ball burst strength/force (ASTM D6797-15) | Substantially equivalent to predicate device |
| - Suture pull-out strength (Internal Test Method) | Substantially equivalent to predicate device |
| - Tear strength (ASTM D2261-13) | Substantially equivalent to predicate device |
| - Tensile strength (ASTM D5035-11) | Substantially equivalent to predicate device |
| Packaging performance | Met |
| Sterilization effectiveness | Met (SAL of 10-6 validated) |
| Shelf-life stability | Met (6 weeks stated in comparison table, but shelf-life "testing" is mentioned without details on the criteria or outcome) |
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.
§ 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.