(263 days)
The Biodesign® Parastomal Hernia Repair Graft is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.
The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) in a sealed double pouch system.
The provided text describes the Biodesign Parastomal Hernia Repair Graft and its substantial equivalence to a predicate device (Permacol® Surgical Implant). The document details performance data through biocompatibility, mechanical testing, and clinical studies.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it describes performance through various tests and clinical outcomes to demonstrate substantial equivalence to a predicate device.
Biocompatibility:
- Acceptance Criteria (Implied): Meet all biocompatibility requirements of the ISO standard for permanent implantable devices.
- Reported Device Performance: "Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices."
Product Characterization - Mechanical:
- Acceptance Criteria (Implied): Adequate mechanical strength for use in abdominal wall defect and hernia repair.
- Reported Device Performance: "Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias."
- Specific mechanical tests performed: Burst strength, Ultimate tensile strength, Device stiffness, Suture retention strength, Tear strength, Delamination. (No specific quantitative results are provided in this summary).
Safety and Performance - Clinical Data (Recurrence Rate for Parastomal Hernias):
- Acceptance Criteria (Implied): Safe and effective use for repairing parastomal hernias, comparable to existing treatments or with an acceptable recurrence rate.
- Reported Device Performance:
- Short-term (Median 18 months): 10% recurrence (2 out of 20 patients).
- Long-term (Median 53 months): 25% recurrence (5 out of 20 patients).
- Graft-Related Complications: 4 seromas in initial 10 patients (resolved by routine drain placement). No other complications reported long-term.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 20 patients for the clinical study directly referenced (Ellis A).
- Data Provenance: The primary clinical study cited is a published peer-reviewed publication by Ellis CN, titled "Short-term outcomes with the use of bioprosthetics for the management of parastomal hernias" (2010). This indicates retrospective or prospective data collection from a clinical setting, though the exact nature (e.g., country of origin) is not specified in the provided text. The document also mentions "Unpublished long term data on 19/20 patients," which suggests an extension of this initial cohort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The clinical data is derived from a published peer-reviewed study. For clinical studies, the "ground truth" (e.g., diagnosis of recurrence, identification of complications) is typically established by the physicians and medical staff involved in the study. The text does not specify the number of experts, their qualifications, or the specific process they used to establish the ground truth for the clinical data. It just refers to "patients," implying clinical observation and diagnosis by healthcare professionals.
4. Adjudication Method for the Test Set
The text does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's outcomes (recurrence, complications). Clinical study outcomes are generally determined by the treating physicians or study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. The clinical study cited focuses on the outcomes of the SIS-based device itself, not on comparing performance of human readers with and without AI assistance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device is a physical medical implant (a surgical graft), not an algorithm or AI. Therefore, the concept of a "standalone study" for an algorithm's performance without a human-in-the-loop is not applicable to this device. The studies performed directly assess the device's physical and biological performance in a clinical setting.
7. The Type of Ground Truth Used
- Biocompatibility and Mechanical Testing: The "ground truth" for these tests are the established ISO standards and FDA guidance documents, which define acceptable physical and biological characteristics. The results directly measure these characteristics.
- Clinical Data: The "ground truth" for the clinical study outcomes (recurrence, complications) is based on expert clinical diagnosis (e.g., physical examination, radiological (CT) examination) and patient outcomes data collected during follow-up.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as the device is a physical graft, not a machine learning model. The biocompatibility and mechanical tests are performed on the device itself, and the clinical study provides evidence of its performance in patients.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" is not relevant for this type of medical device. The "ground truth" for the device's safety and performance is established through adherence to regulatory standards (biocompatibility, mechanical testing) and clinical observations/diagnoses in patient studies.
§ 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.