(88 days)
Endoform Reconstructive Template is intended for usc as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.
This document is a 510(k) premarket notification for a medical device called the "Endoform® Reconstructive Template" (ERT), which is a surgical mesh. The purpose of this notification is to declare that a modified version of the ERT is substantially equivalent to a previously cleared predicate device. The only change proposed is an increase in the maximum device size.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Parameter) | Reported Device Performance (Goal) | Study Finding |
|---|---|---|
| Bench Testing | "meets all product specifications" | |
| Mechanical Strength | Adequate for intended use | Ensured through bench testing |
| Endotoxin | Within acceptable limits | Ensured through bench testing |
| Dimensional Verification | Accurate dimensions | Ensured through bench testing |
| Validation Testing | "meets all product specifications" | |
| Manufacturing Process Validation | Robust and consistent | Achieved |
| Labeling Validation | Accurate and compliant | Achieved |
| Packaging Transportation Validation | Maintains integrity during transit | Achieved |
| Sterilization (SAL) | 10⁻⁶ | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific numerical sample sizes for each test set (e.g., how many devices were tested for mechanical strength, endotoxin, etc.). It only broadly refers to "bench testing and validation testing."
- Test Set Sample Size: Not explicitly stated (e.g., number of units tested per bench test).
- Data Provenance: The studies were conducted by Aroa Biosurgery, Limited, which is based in New Zealand. The studies appear to be prospective for the modified device based on the phrase "Performance and validation testing executed based on risk analysis of the proposed change supports the substantial equivalence..."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in this context. The "acceptance criteria" here refer to engineering and manufacturing specifications (e.g., mechanical strength, sterility, dimensions) for a physical medical device. Ground truth, in the context of expert consensus, is typically relevant for diagnostic devices or those requiring human interpretation of results. For this surgical mesh, the "ground truth" is defined by the established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts when establishing a ground truth, often for image interpretation or clinical diagnosis. Since the "acceptance criteria" for this device are based on objective physical and chemical measurements (bench testing, sterility), there is no human interpretation or adjudication involved in meeting these criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was submitted to support the safety and effectiveness of the modified Endoform Reconstructive Template." MRMC studies inherently involve human readers and clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. A "standalone" performance typically refers to the performance of an algorithm or AI system without human intervention. The Endoform Reconstructive Template is a physical surgical mesh, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" (or basis for acceptance) for this device's performance is based on established product specifications, engineering standards, and regulatory requirements. This includes:
- Pre-defined mechanical strength targets.
- Specified endotoxin limits.
- Dimensional tolerances.
- Sterility Assurance Level (SAL) of 10⁻⁶.
- Biocompatibility as demonstrated by the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. The Endoform Reconstructive Template is a physical medical device. Its development and testing involve manufacturing processes, material science, and engineering validation, not an AI training paradigm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8. There is no "training set" in the context of this device's development.
§ 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.