(415 days)
MatriStem® Surgical Matrix RS (2-layer) and PSM (3-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hemia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
MatriStem® Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
MatriStem® Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation.
The provided text describes a medical device premarket notification (510(k)) for MatriStem® Surgical Matrix products, which are composed of porcine-derived extracellular matrix scaffolds. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested criteria for studies proving device performance may not be directly applicable or available in this document. The document primarily details biocompatibility and mechanical testing to support substantial equivalence.
Here's the information extracted and interpreted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics, as it is a 510(k) submission focused on substantial equivalence based on material and mechanical properties, and intended use. The "performance" reported relates to these characteristics and their comparison to predicate devices.
| Acceptance Criteria (Implied from testing) | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO-10993-1 standard) |
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous reactivity
- Acute systemic toxicity
- Pyrogenicity
- Subacute and subchronic toxicity and implantation
- Genotoxicity
- Hemocompatibility
- LAL endotoxin | "The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard." (The document states compliance without providing specific quantitative results for each test.) |
| Mechanical Strength (Adequate for respective applications) - Tensile strength
- Suture retention strength
- Delamination strength
- Tear strength
- Stiffness test | "The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications." (Specific quantitative values are not provided, but the document states that the devices have "comparable performance to the predicates" and the "available sizes...are consistent with the range of sizes of the predicate devices.") |
| Substantial Equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. | "MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix have the same intended use as predicate surgical meshes...The technological characteristics...are substantially similar to the cleared predicates...The minor differences...do not raise different questions of safety or efficacy and performance testing demonstrates that the devices have comparable performance to the predicates."
"Based on direct testing and comparison to predicate devices, MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence..." |
The following points are generally not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence through non-clinical testing (biocompatibility, mechanical) and comparison to predicates, rather than a prospective clinical study proving specific performance criteria in patients.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not applicable as no clinical test set data from a study involving patients is presented. The "test set" for biocompatibility and mechanical testing would refer to samples of the device material itself. The document does not specify the number of material samples tested or their provenance beyond being the device materials.
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)
- Not applicable; relevant for clinical studies with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; relevant for clinical studies with expert review.
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 for AI/CAD-related devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is for AI/CAD-related devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the biocompatibility and mechanical testing, the "ground truth" would be established by validated scientific methodologies and ISO standards, rather than expert consensus or patient outcomes data. For substantial equivalence, the predicates serve as a comparative standard.
8. The sample size for the training set
- Not applicable; this is for AI/machine learning models.
9. How the ground truth for the training set was established
- Not applicable; this is for AI/machine learning models.
§ 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.