(87 days)
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin that has both the epidermal and subdermal sides removed. The product is available in several sizes.
The provided text is a 510(k) summary for the Porcine Dermal Matrix Surgical Mesh. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.
Therefore, many of the requested points cannot be answered from the provided text, as the information is not typically included in a 510(k) summary for a Class II device like a surgical mesh.
Here's an attempt to answer based only on the provided text, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: |
- Intended use
- Mode of action
- Design
- Does not raise new issues of safety or effectiveness | Substantially equivalent to DermMatrix, Permacol/Pelvicol, and SurgiMend surgical meshes.
- Equivalent in intended use, mode of action, and design.
- Introduction does not raise any new issues of safety or effectiveness.
- Biocompatibility testing per ISO 10993-1 demonstrated device is "safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices." |
| Performance as Intended | "Test evaluations of Porcine Dermal Matrix show that the device performs as intended." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "biocompatibility testing" and "bench testing" but does not provide details on the sample sizes used for these tests.
- Data Provenance: Not specified, beyond general "biocompatibility testing conducted per ISO 10993-1, bench testing and numerous clinical experiences." No country of origin is mentioned, nor is it explicitly stated if the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The study design does not appear to involve human readers or ground truth established by experts in the context of diagnostic performance. The evaluation is based on material properties and biological compatibility.
4. Adjudication method for the test set
- Not applicable/not provided. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation (e.g., radiology reads), which is not the nature of the evidence presented for this device.
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
- No. An MRMC comparative effectiveness study was not done, as this is a surgical mesh with a focus on material properties and biological integration, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical product (surgical mesh), not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for this device's substantial equivalence and safety/effectiveness relies on biocompatibility testing results (per ISO 10993-1) and bench testing results for its material properties and performance. It also relies on the established safety and effectiveness profile of the predicate devices with which it demonstrates equivalence. No pathology or outcomes data is explicitly detailed as "ground truth" for the current device's performance, but rather for the predicate devices and generally accepted biocompatibility standards.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.