(119 days)
The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.
The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.
This document describes a 510(k) submission for the IntePro® Y-Mesh. The key information is that the device is identical in all technical characteristics (design, materials, manufacturing, intended use) to its predicate device, the IntePro® AMS Large Pore Polypropylene Mesh (K040521).
Therefore, the submission does not include a study to prove the device meets acceptance criteria in the way you've outlined. This is because the regulatory pathway chosen, a 510(k) for substantial equivalence, relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. When a device is identical to its predicate, no new performance studies are typically required to establish new acceptance criteria.
The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This determination is based on the claim of identity to the predicate.
Therefore, many of the requested fields are not applicable to this 510(k) submission. I will indicate "Not Applicable" or explain why the information isn't present based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (see explanation below) | Not Applicable (see explanation below) |
Explanation: The 510(k) summary states, "All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use." Because the device is claimed to be identical to a previously cleared predicate device (IntePro® AMS Large Pore Polypropylene Mesh, K040521), specific new acceptance criteria and a study to prove performance against new criteria are not presented in this summary. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.
2. Sample size used for the test set and the data provenance
Not Applicable. No new performance testing in a "test set" for clinical data is described for this specific device in the provided summary, as it relies on substantial equivalence to an identical predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No new clinical performance testing requiring expert ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No new clinical performance testing requiring adjudication 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 is a surgical mesh device, not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a surgical mesh device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No new clinical performance testing requiring ground truth for this device is described. The basis for clearance is identity to a predicate device.
8. The sample size for the training set
Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set.
9. How the ground truth for the training set was established
Not Applicable. This is a surgical mesh device, not an algorithm requiring a training set and associated ground truth.
§ 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.