(113 days)
The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung resections . - Biopses . - Lobectomies - Gastric banding - Abdominal and thoracic wall repair
The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.
The provided text does not contain detailed information regarding specific acceptance criteria, a comprehensive study report, or the associated performance metrics in the format requested. The document primarily describes the device, its intended use, and states that "Tissue functional testing was carried out in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh. The test results demonstrate suitable material properties for the indications of the device."
Therefore, I cannot populate the table or answer most of the specific questions.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document generically states "suitable material properties for the indications of the device." | Not specified in detail. The document only states "test results demonstrate suitable material properties." Specific quantitative performance metrics (e.g., tensile strength, burst pressure, suture retention strength, biocompatibility, porosity, etc.) are not provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "Tissue functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study described is "Tissue functional testing" which typically involves laboratory or bench testing of material properties, not human interpretation or a "ground truth" established by experts in the context of imaging or diagnostic devices.
4. Adjudication method for the test set:
- Not applicable as this is not a study involving human interpretation or clinical endpoints requiring adjudication.
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, a MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used:
- For "Tissue functional testing," the "ground truth" would be the established scientific and engineering standards and specifications for surgical mesh materials. These standards are typically based on material science, biomechanics, and ISO/ASTM guidelines for medical devices. The document references "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," implying that the ground truth for performance assessment aligns with these regulatory and scientific guidelines.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
Summary of Study Information:
- Study Type: Tissue functional testing.
- Purpose: To demonstrate suitable material properties for the device's indications.
- Compliance: Conducted in accordance with "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
- Conclusion: The test results demonstrate suitable material properties.
Missing Information:
The provided text lacks specific details on:
- The exact tests performed (e.g., tensile strength, burst strength, suture retention, biocompatibility).
- The specific quantitative acceptance criteria for each test.
- The quantitative results obtained for the PeriPatch Aegis.
- Sample sizes used for this testing.
§ 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.