(118 days)
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead. The proposed sling is packaged with (2) delivery devices (Halo or Curved) which are used in conjunction with the mesh assembly to place the mesh implant. Each of the delivery devices consist of a polymer handle and a stainless steel needle which extends from the handle. The tip of the needle has a slot which is used to attach the association loop of the mesh assembly.
The provided 510(k) summary for the Obtryx II System does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device.
This document describes a traditional 510(k) for a surgical mesh (Obtryx II System) used for stress urinary incontinence. The approval is based on "substantial equivalence" to predicate devices (Advantage, Advantage Fit & Lynx Systems, Obtryx, Prefyx Systems) through non-clinical testing, rather than a clinical study with defined performance acceptance criteria.
Therefore, many of the requested details are not applicable or cannot be extracted from this specific 510(k) document.
Here's a breakdown of the information that is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Not Explicitly Stated but Inferred) | Reported Device Performance |
|---|---|
| Material Properties: Suitable for intended use | Device meets predetermined specifications. Test results demonstrate suitability. |
| Biocompatibility: Meet EN ISO 10993-1 | Device is biocompatible for its intended use. Test results demonstrate compliance. |
| Bench Testing: Meet performance specifications | Device meets predetermined specifications. Test results demonstrate acceptable performance for clinical use. |
| Substantial Equivalence to Predicates (K020110 & K040787): | The proposed sling is "as safe, as effective, and performs as well as the predicate devices" in terms of intended use, technological characteristics (mesh design and material), and performance characteristics tested. |
Explanation: The document states that "Material testing was performed to demonstrate that the material properties are suitable for the intended use," "Bench testing was performed to demonstrate that the device as manufactured meets performance specifications," and "Biocompatibility testing was performed... and results demonstrate that the device is biocompatible for its intended use." These imply that acceptance criteria were met, but the specific numerical targets or thresholds are not disclosed in this summary. The primary "acceptance criteria" for this 510(k) path is demonstrating substantial equivalence to already approved predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This 510(k) relies on non-clinical (material, bench, biocompatibility) testing and comparison to predicate devices, not human subject testing with a "test set" in the context of an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This information pertains to studies establishing ground truth for diagnostic or prognostic AI/ML algorithms. This document describes a surgical mesh, not a diagnostic algorithm.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic imaging AI tools comparing human performance with and without AI assistance. This document describes a physical medical device (surgical mesh).
6. Standalone Performance Study (Algorithm Only):
- Not Applicable. There is no "algorithm" in the context of an AI/ML system to evaluate for this surgical mesh device.
7. Type of Ground Truth Used:
- For non-clinical testing, the "ground truth" would be the established engineering specifications for material properties, biocompatibility standards (e.g., EN ISO 10993-1), and device performance specifications.
- For substantial equivalence, the "ground truth" is established by the safety and effectiveness of the legally marketed predicate devices.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 8.
In summary: The Obtryx II System gained 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices through comprehensive non-clinical testing (material, bench, and biocompatibility). This approval pathway does not require the types of clinical studies, expert-adjudicated test sets, or AI/ML algorithm performance metrics that your questions typically address.
§ 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.