(50 days)
The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.
The Caldera Polypropylene Mesh is made of monofilament polypropylene mesh. The Caldera Polypropylene Mesh is a sterile, single-use mesh used to provide additional support to weak muscle in specific urological, gynecological, or gastroenterological procedures.
It is provided in a variety of pre-formed sizes and shapes as well as a large size that can be cut to size by the physician.
The Caldera Polypropylene Mesh is available as the mesh only, without accessory items.
The provided text describes a 510(k) premarket notification for the Caldera Large Pore Monofilament Polypropylene Mesh. This submission is for a medical device and not an AI or algorithm-driven system. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.
The document discusses the regulatory approval process for a surgical mesh, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is characteristic of a traditional medical device approval, not a study evaluating an algorithm's diagnostic or predictive performance.
Here's the relevant information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document summarizes the basis for regulatory approval, which is "substantial equivalence" to a predicate device. This means the new device is as safe and effective as a device already on the market. Specific performance metrics are not given in an acceptance criteria table because the submission relies on similarity to an existing device rather than novel performance claims from a dedicated clinical study for this specific mesh.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices | Deemed substantially equivalent to predicate devices. |
| Biocompatibility | Testing performed and found appropriate. |
| Appropriate Physical Testing (as per FDA Guidance "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh") | Testing performed and found appropriate. |
| Sterility | The device is sterile (stated in Device Description). |
| Single-use | The device is single-use (stated in Device Description). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. This is a 510(k) submission for a non-AI medical device based on substantial equivalence to a predicate device, not a performance study against a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. Ground truth establishment for a test set is not described as this is not a study assessing diagnostic performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication is mentioned.
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 non-AI medical device; therefore, MRMC studies related to AI assistance are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical mesh device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of an algorithm's performance. For a medical device like surgical mesh, the "ground truth" for safety and effectiveness is established through adherence to recognized standards for biocompatibility and physical properties, and by demonstrating substantial equivalence to similar devices with a history of safe and effective use.
8. The sample size for the training set:
Not applicable. This is a non-AI medical device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set mentioned for this type of device submission.
§ 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.