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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."

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.

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The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AFTM) is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.

The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF") is a medical device consisting of a Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. The PICS-AF Closure System is designed as a sphincter-sparing device that inhibits the movement of enteric matter into the anorectal fistula tract and to provide a scaffold for tissue ingrowth to occur to close the anorectal fistula.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., a target success rate the device must achieve). Instead, it presents the results of a clinical study and concludes based on those results that the device is safe and effective and substantially equivalent to predicate devices. However, we can infer the primary effectiveness and safety endpoints as success criteria:

2. Sample Size Used for the Test Set and Data Provenance

• PICS-AF Test Set: 30 subjects
• Historical Control Test Set: 19 subjects (treated with GORE BIO-A Fistula Plug)
• Data Provenance: Retrospective and prospective. The PICS-AF study was a prospective, non-randomized clinical study conducted at one clinical site in Europe. The historical control data was also collected at the "same clinical site."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Three independent U.S. radiologists.
• Qualifications: "Independent U.S. radiologists." No further specific details (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

• The MRI results (used to assess fistula closure success) were "reviewed and adjudicated by three independent U.S. radiologists."
• The specific adjudication method (e.g., 2-out-of-3 majority, consensus, etc.) is not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• This was not an MRMC comparative effectiveness study in the typical sense of evaluating human readers with and without AI assistance.
• It was a clinical study comparing the CuraSeal PICS-AF device to a historical control (GORE BIO-A Fistula Plug) based on patient outcomes, where human experts (radiologists) were solely used to establish the ground truth of fistula closure from MRIs.
• Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This device is a physical surgical mesh, not an AI algorithm.
• Therefore, a standalone algorithm performance study was not conducted or relevant. The performance reported is that of the physical device.

7. Type of Ground Truth Used

• Effectiveness: For fistula closure, the ground truth was established by expert consensus/adjudication from three independent U.S. radiologists based on Month 6 MRIs. The definition of success was "complete healing of the fistula tract and associated external opening without drainage or abscess."
• Safety: Ground truth for safety endpoints (e.g., serious adverse events) was based on clinical observation and reporting, likely through a combination of medical records, physician assessments, and patient follow-up.

8. Sample Size for the Training Set

• This device is a physical medical device, not an AI algorithm. Therefore, there is no concept of a training set in the context of machine learning. The "training" would refer to the design, manufacturing, and preclinical testing phases.

9. How the Ground Truth for the Training Set Was Established

• As stated above, this is not an AI algorithm, so the concept of a training set and its ground truth is not applicable in this context.

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