(287 days)
The ALYTE™ Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.
The ALYTE™ Y-Mesh Graft is composed of lightweight/ultralight, non-absorbable, monofilament, polypropylene mesh. The Y configuration of the design provides two wide layers of mesh (A/P flaps) for anterior and posterior vaginal attachment that combine seamlessly into one double layer mesh (Sacral flap) for attachment to the anterior longitudinal ligament. The ALYTE™ Y-Mesh Graft contains a center line indicator created by knitting a blue polypropylene fiber in the mesh. The anterior and posterior flaps (A/P flaps) contain additional lateral indicator stripes also made from the same blue polypropylene fiber to provide guidance for placement. The graft is designed such that the surgeon will be able to alter/trim the graft to different sizes and lengths as required to fit each patient's anatomical requirements without unraveling.
The provided text describes the ALYTE™ Y-Mesh Graft, a surgical mesh, and its substantial equivalence to predicate devices. However, it does not explicitly define "acceptance criteria" in a quantitative manner or provide a detailed study proving the device meets specific numerical acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to already cleared devices based on technological characteristics and a retrospective clinical survey.
Here's an attempt to extract the requested information, noting where specific details are not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition Equivalence: Material is non-absorbable, polymeric mesh. | The ALYTE™ Y-Mesh Graft is composed of a non-absorbable, polymeric mesh material, identical to the predicate Alyte Y-Mesh (K090739) and substantially equivalent to the Caldera Mesh device (K060004). |
| Design Equivalence (Y-configuration): The device has a Y configuration for vaginal and sacral attachment. | The design of the subject device is a Y configuration, which is identical to the predicate Alyte Y-Mesh (K090739) and similar to the AMS Sacral Colpopexy Sling (K010931). |
| Mechanical Performance: Equivalent to predicate devices. | Non-clinical performance characterized in accordance with FDA Guidance (March 22, 1999) to demonstrate substantial equivalence. Components have been subjected to mechanical testing and are identical to K090739 and substantially equivalent to K060004. |
| Stability (if changed from prior clearance): Device stability maintained. | The subject device is unchanged from the device cleared in K090739; therefore, stability testing was not repeated. |
| Biocompatibility (if changed from prior clearance): Device biocompatibility maintained. | The subject device is unchanged from the device cleared in K090739; therefore, biocompatibility testing was not repeated. |
| Effectiveness (correction of pelvic organ prolapse): Effectiveness shown in sacrocolpopexy. | Clinical survey reported median POP-Q stage at median follow-up of approximately 6 months was Stage 0-1 (implying correction). Supported by a review of peer-reviewed literature showing effectiveness of synthetic mesh in sacrocolpopexy to correct pelvic organ prolapse. |
| Vaginal Erosion Rate: Within a clinically acceptable range. | Clinical survey reported Rate of erosion of mesh in this survey was 2/69 (2.9%). The submission states Vaginal erosion was within a clinically acceptable range based on the literature review. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Survey): 69 sacrocolpopexy procedures.
- Data Provenance: European retrospective survey.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 17 surgeons.
- Qualifications of Experts: Not explicitly stated beyond "surgeons." No specific experience level (e.g., "radiologist with 10 years of experience") is provided.
4. Adjudication Method for the Test Set
- Not applicable. The data is from a retrospective survey of outcomes reported by individual surgeons, not a consensus-based adjudication process.
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 multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical mesh, not an AI-driven interpretive tool for human readers.
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 (expert consensus, pathology, outcomes data, etc.)
- For the clinical evaluation, the "ground truth" was based on patient outcomes data (POP-Q stage, mesh erosion rates) as reported by the surgeons in the retrospective survey and observed in the peer-reviewed medical literature. The POP-Q (Pelvic Organ Prolapse Quantification) system is a standardized assessment tool used by clinicians.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical mesh, not an AI/ML algorithm that requires a "training set" in the computational sense. The "design" and "material composition" could be considered "trained" by prior predicate devices and general medical knowledge, but no explicit training set is mentioned.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See #8).
§ 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.