(168 days)
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.
The SIS Hernia Repair Device is intended to be used for reconstructing and supporting soft tissues such as fo the repair of a hernia or body wall defect. The device is supplied sterile and is intended for one-time use. The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use.
The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested parameters such as sample sizes, expert qualifications, or ground truth methods.
This document is a 510(k) summary for the SIS Hernia Repair Device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than detailing a specific clinical performance study with acceptance criteria.
Here's what can be extracted from the text, along with what is explicitly not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use." (General statement, no specific metrics or targets reported) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document refers generally to "biocompatibility and performance testing" but provides no details on the nature or results of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- This device is a physical hernia repair device, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI would not be applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not specified. The document broadly states "biocompatibility and performance testing," but the specific methods or underlying "ground truth" used for these tests are not detailed. For a physical device, this might refer to histological analysis, mechanical strength tests, or animal model outcomes, but none are elaborated upon.
8. The sample size for the training set
- Sample Size (Training Set): Not specified. The concept of a "training set" in the context of device performance data, as understood for AI/machine learning, is not applicable or discussed for this physical device.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as there is no mention of a training set for an algorithm.
Summary of Information Provided:
The document is a regulatory submission focused on substantial equivalence. It confirms:
- The device is a SIS Hernia Repair Device (surgical mesh).
- It's intended for reconstructing and supporting soft tissues (hernia or body wall defect repair).
- It's supplied sterile and for single-use.
- It has undergone "appropriate biocompatibility and performance testing" to assure safety and efficacy.
- It is considered substantially equivalent to predicate surgical meshes in terms of indications for use and technological characteristics.
The 510(k) process, particularly in 1998, often relied on demonstrating equivalence to already cleared devices rather than requiring highly detailed de novo clinical performance studies with specific statistical endpoints and ground truth mechanisms as would be expected for a novel diagnostic algorithm today.
§ 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.