(30 days)
Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.
The provided document is a 510(k) summary for a medical device (surgical mesh), which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission does not typically contain the detailed information requested regarding acceptance criteria and a study proving a device meets those criteria in the way a clinical trial or performance study report would.
510(k) submissions, especially for devices claiming substantial equivalence based on material and design similarities, often rely on non-clinical data (e.g., material properties, dimensions) and comparison to a legally marketed predicate. They don't usually involve acceptance criteria related to AI/algorithm performance, human reader studies, or detailed ground truth establishment as would be present for AI/ML-based medical devices or devices with novel performance claims requiring rigorous clinical validation.
Therefore, many of your requested points cannot be answered from the provided text.
Here's an analysis of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria for the subject devices (Restorelle M & XL) are that they are "substantially equivalent" to the predicate device (Restorelle L) in terms of indications, materials, and technological characteristics. The specific metrics for "performance" are based on physical properties, not clinical outcomes in a comparative study.
- Reported Device Performance: The document reports the physical characteristics of both the subject and predicate devices. The "performance" is demonstrated by the equivalence of these characteristics.
| Property | Acceptance Criteria (Equivalent to Predicate) | Reported Subject Device Performance (Restorelle M & XL) | Reported Predicate Device Performance (Restorelle L) |
|---|---|---|---|
| Indications | Must be equivalent to predicate: "Indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted." | "Restorelle M & XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted" | "Restorelle L Polypropylene Mesh is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted" |
| Materials of Construction | Must be equivalent to predicate: "Non-absorbable, monofilament polypropylene mesh" | "Non-absorbable, monofilament polypropylene mesh" | "Non-absorbable, monofilament polypropylene mesh" |
| Dimensions | Not specified as "equivalent" but rather that differences are acceptable if other properties are equivalent and safety/effectiveness maintained. (The subject devices have different dimensions from the predicate). | 10cm x 15cm (M), 30cm x 30cm (XL) | 24cm x 8cm (L) |
| Shape | Must be equivalent to predicate: "Flat" | "Flat" | "Flat" |
| Pore Size (mm) | Must be equivalent to predicate: "1.80 x 1.83" | "1.80 x 1.83" | "1.80 x 1.83" |
| Sterilization Method | Must be equivalent to predicate: "Ethylene Oxide" | "Ethylene Oxide" | "Same" (meaning Ethylene Oxide as per previous submission) |
| Regulatory Status | Implied: Pending | Pending | Cleared K122440 (L) |
| Product Code | Must be equivalent to predicate: "OTO" | OTO | OTO |
The overarching "acceptance criterion" as explicitly stated in the Conclusions: "The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh."
The following information cannot be found in the provided 510(k) summary:
- 2. Sample size used for the test set and the data provenance: Not applicable here as this is a physical device comparison, not a data-based algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML device or an imaging device requiring human reader interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable as this is not an AI/ML device requiring clinical ground truth for performance. The "ground truth" for this submission is the established properties and safety of the predicate device.
- 8. The sample size for the training set: Not applicable (no AI/ML model).
- 9. How the ground truth for the training set was established: Not applicable (no AI/ML model).
Summary of the Study/Evidence Provided:
The "study" in this context is the submission for a 510(k) premarket notification. The company Coloplast A/S is seeking clearance for two new mesh sizes (Restorelle M and XL) by demonstrating their substantial equivalence to a previously cleared predicate device, Restorelle L (K122440).
The core of the study is a comparison of technological characteristics. The "performance" is proven by showing that the new devices share the "same materials, features, intended use, and technological characteristics" as the predicate device, with the only difference being the mesh size.
This is a non-clinical comparison study, relying on the established safety and effectiveness of the predicate device rather than new clinical trials on the subject devices themselves.
§ 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.