(40 days)
FortaPerm™ is intended for implantation to reinforce and support soft tissue where weakness exists including, but not limited to the following procedures: pubourethral support, prolapse repair (urethral, vaginal, rectal and colon), reconstruction of the pelvic floor, bladder support, sacrocolposuspension, reconstructive procedures and tissue repair. By providing pubourethral support, FortaPerm may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is intended for one-time use.
Forta Perm consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 2 x 5 cm to 12 x 36 cm in sterile double laye packaging.
The submitter, Organogenesis Inc., provided limited information regarding the performance data for FortaPerm™ Surgical Mesh. The application states, "FortaPerm was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests."
However, specific acceptance criteria and detailed quantitative results of these tests are not explicitly stated in the provided documents. The information is very general and does not allow for a comprehensive breakdown as requested.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not Specified) | Passed all requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g. country of origin, retrospective or prospective).
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 as this is a medical device (surgical mesh), not an AI/imaging device requiring expert ground truth for interpretation of results. The "ground truth" would likely be laboratory or animal model assessments of material performance and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device performance testing.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be established by standard scientific and engineering methodologies for evaluating biocompatibility, integrity, and performance of surgical mesh biomaterials (e.g., in vitro mechanical testing, biocompatibility assays, animal implantation studies). Specific details are not provided in the document.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of Study (Based on Provided Information):
The submission states that FortaPerm™ was subjected to a "panel of tests to assess biocompatibility, integrity, and performance" and "The device passed the requirements of all tests." No further details on the specific tests, their methodologies, sample sizes, or quantitative results are provided in the excerpt. The substantial equivalence claim is based on its similarity to predicate devices (GraftPatch and Surgisis Sling) in terms of intended use, technological characteristics, materials, physical construction, and performance.
§ 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.