(169 days)
The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
The Biodesign® Fistula Plug is a fistula repair device made from porcine SIS, a collagen rich, bioresorbable, extracellular matrix (ECM)-based biomaterial. The device design consists of a tapered SIS cylinder (plug body) and an SIS flange/button connected together using biodegradable polyglycolic acid (PGA) surgical suture. The function of the plug body is to fill the fistula tract and the function of the flange/button is to anchor the device at the internal fistula opening. Three different size offerings (2mm, 5mm and 7mm) are available based on the diameter of the primary end of the plug.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving device meets acceptance criteria. Therefore, most of the requested information cannot be fully extracted or is not applicable in this context.
Here's what can be inferred or directly stated from the provided document:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical testing performed to demonstrate substantial equivalence but does not explicitly list acceptance criteria values for each test. Instead, it states that "The results of the testing confirm that the subject device does not pose new or different biocompatibility risks and can withstand the expected mechanical forces on the device."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Confirmed no new or different biocompatibility risks |
| Performance (Mechanical) | Confirmed can withstand expected mechanical forces |
Specific tests performed:
- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation (on SIS and PGA suture).
- Performance Testing Bench: Extrusion resistance testing, Tensile strength testing, Plug suture retention strength.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details on sample sizes for the non-clinical tests (e.g., number of samples for extrusion resistance, number of animals for biocompatibility). It also does not discuss data provenance for these tests (country of origin, retrospective/prospective), as these are typically laboratory bench and animal studies, not human clinical trials.
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. This is a non-clinical submission, not an image-based diagnostic device or one involving human expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a non-clinical submission.
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 a physical medical device (fistula plug), not an AI-based diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as it is not an algorithm/AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For biocompatibility, the "ground truth" would be established by standard biological assays and observation for adverse reactions in animal models, comparing to established safety profiles of materials. For mechanical tests, the "ground truth" is based on engineering specifications and physical test methods.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/machine learning device.
§ 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.