(235 days)
The Alyte™ Y-Mesh Graft is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The Alyte™ Y-Mesh Graft is a surgical implant used in the repair of vaginal wall prolapse. The graft is comprised of a lightweight/ultra-lightweight, nonabsorbable monofilament polypropylene mesh. The graft is designed such that the surgeon will be able to alter/trim the graft to different sizes as required to fit each patient's anatomical requirements without unraveling. The graft is available in a Y shape as a convenience to the physician.
This document is a 510(k) Pre-market Notification for the Alyte™ Y-Mesh Graft. It is a submission to the FDA for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study report proving device performance against acceptance criteria in the manner usually associated with clinical trials or diagnostic accuracy studies for AI devices.
Therefore, many of the requested categories are not applicable to this type of document. I will fill in what is available and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in terms of performance metrics or thresholds for the device in the way a clinical trial or AI performance study would. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices, as defined by FDA regulations.
The reported "device performance" in this context refers to the technological characteristics and safety assessed through non-clinical testing, which are deemed equivalent to the predicate devices.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device "Performance" (as asserted for Substantial Equivalence) |
|---|---|
| Same Intended Use as Predicate Devices | The device is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, which is the same intended use as the predicate devices. |
| Same Technological Characteristics as Predicate Devices | The device is comprised of a lightweight/ultra-lightweight, nonabsorbable monofilament polypropylene mesh, designed for altering/trimming. It has the same technological characteristics as the predicate devices. |
| Appropriate Testing Completed (e.g., Guidance for Surgical Mesh) | "The appropriate testing to determine substantial equivalence was completed. This includes testing in accordance with Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (March 22, 1999)." Details of specific test results (e.g., tensile strength, pore size, biocompatibility) are not provided in this summary but would have been part of the full 510(k) submission. |
| No New Questions of Safety or Effectiveness Raised | Implied by the FDA's clearance (substantial equivalence determination). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing refers to "appropriate testing" completed in accordance with FDA guidance for surgical mesh, but does not detail the specific tests, their methodologies, sample sizes, or data provenance (e.g., animal studies, in vitro tests, or any human data). Clinical "test sets" in the context of human subjects are typically not a primary component of a 510(k) for surgical mesh unless specific clinical data is required to establish substantial equivalence or address specific safety/effectiveness questions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. "Ground truth" established by experts in the context of diagnostic accuracy or AI performance studies is not a component of a 510(k) for surgical mesh. The evaluation is based on engineering tests, biocompatibility, and comparison to predicate devices, not expert consensus on interpretations of data from a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., reading medical images) where discrepancies need resolution. This 510(k) pertains to a physical medical device (surgical mesh) and its performance through non-clinical testing.
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 information is not applicable. MRMC studies are used for evaluating the impact of diagnostic aids (often AI-powered) on human reader performance. The Alyte™ Y-Mesh Graft is a surgical implant, not a diagnostic tool or an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. A standalone algorithm performance study is relevant for AI devices. The Alyte™ Y-Mesh Graft is a physical surgical mesh.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed in point 3, the concept of "ground truth" as typically used in diagnostic or AI studies is not applicable here. The substantial equivalence determination for this surgical mesh is based on conformity to established material and performance standards, and comparison to legally marketed predicate devices, rather than a clinical "ground truth." For material properties, the "ground truth" would be the measured physical properties (e.g., tensile strength, pore size, material composition) as determined by laboratory testing against specifications or established norms.
8. The sample size for the training set
This information is not applicable. The Alyte™ Y-Mesh Graft is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As it's not an AI model, there is no training set or ground truth in that context.
§ 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.