(162 days)
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:
| Acceptance Criteria (Inferred from Study Endpoints) | Reported Device Performance (CuraSeal PICS-AF) | Comparator Performance (GORE BIO-A Fistula Plug) |
|---|---|---|
| Effectiveness: Fistula closure success at 6 months (defined as complete healing of fistula tract and external opening without drainage or abscess) | 46.67% (14/30) in Intent-to-Treat (ITT) population; 66.67% (14/21) in Per Protocol (PP) population | 5.56% (1/18) |
| Safety: Proportion of subjects experiencing a serious adverse event (e.g., infection, fistula enlargement, allergic reaction) through 6 months post-procedure | 10.00% (3/30) | 0% (0/19) |
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.
§ 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.