(122 days)
The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.
The Inclose ™ Surgical Mesh System is comprised of a Mesh Implant and two suture assembles (Anchor Bands). The implanted components are provided sterile and preloaded on their respective disposable delivery instruments. The Mesh Implant is an expandable braided patch that is inserted through the aperture of the tissue defect and affixed to surrounding soft tissue with the Anchor Bands. Materials utilized in the construct of the implanted components consist of polyethylene terephthalate (PET). In addition, two platinum/iridium markers are placed on monofilament fibers and positioned toward the proximal end of the mesh. These two markers are located 180° from each other and are intended to facilitate identification of the Inclose™ Mesh Implant following surgery. Standard operating room sutures may also be utilized for fixation of the device.
The provided text describes a 510(k) summary for the Anulex Technologies Inclose™ Surgical Mesh System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.
Therefore, many of the requested sections regarding acceptance criteria, device performance, study design, and ground truth establishment cannot be found in the provided text. The K050969 document for the Inclose™ Surgical Mesh System is a 510(k) premarket notification. These notifications primarily demonstrate substantial equivalence to legally marketed predicate devices, not novel performance claims through clinical trials with established acceptance criteria.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for novel performance claims. | The device is deemed "substantially equivalent in intended use, scientific technology, materials and design to predicate devices in interstate commerce." |
| Functional and Safety Testing Results: "Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Inclose™ Surgical Mesh System." (Specific results or metrics are not detailed). |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable or not provided. This is a 510(k) submission, not a new clinical study with a test set. The submission relies on demonstrating equivalence to existing predicate devices.
- Data provenance: Not applicable. The "study" referenced is primarily bench and biocompatibility testing, not human-subject testing with a test set for performance evaluation in the usual sense for AI/medical device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set is described or implied in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No adjudication method for a test set is described.
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
- Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. No ground truth as defined for evaluating a diagnostic or AI device is mentioned. The "ground truth" for this device's safety and effectiveness implicitly relies on the established safety and effectiveness of its predicate devices, supported by bench and biocompatibility testing.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm requiring 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.