(115 days)
The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.
The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.
The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.
The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.
The provided text describes a 510(k) summary for the AMS Collagen Dermal Matrix. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study proving device meeting acceptance criteria as would typically be conducted for and reported for an AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. The submission focuses on demonstrating equivalence to existing surgical mesh products.
However, I can extract information related to the device's intended use and the general claim of meeting "requirements" for this type of device.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent to predicate surgical meshes for indications of use. | "The AMS collagen dermal matrix and all of the pre-connected devices have been tested in accordance with the requirements of FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices." |
| Suitable for soft tissue reinforcement where weakness exists. | Intended for use in "reinforcing soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy." |
| Safe and effective for specific procedures (e.g., urethral slings, prolapse repair). | Indications for Use explicitly list these procedures. |
| Biocompatible (implied for decellularized porcine dermis). | Described as "decellularized porcine dermis that is lyophilized and terminally sterilized." |
Explanation of "Acceptance Criteria" for a 510(k) of this nature:
For a 510(k) submission like this one (for a traditional medical device prior to the widespread use of AI/ML), "acceptance criteria" are not typically quantitative thresholds on metrics like accuracy or sensitivity. Instead, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:
- Similar intended use.
- Similar technological characteristics (materials, design).
- Evidence that any differences in technological characteristics do not raise new questions of safety or effectiveness.
The "testing" mentioned typically involves biocompatibility, mechanical properties, sterilization validation, and often animal studies, which are compared to known properties of the predicate devices or established standards. The text does not provide granular details of these tests or their specific outcome values.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) for a surgical mesh, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance on data. The "testing" refers to benchtop, possibly animal, and material property tests to establish equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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 not an AI/ML device, and no MRMC study was mentioned or would be relevant for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Not Applicable. For a surgical mesh, "ground truth" relates to the performance and safety characteristics established through laboratory testing (e.g., tensile strength, biocompatibility, porosity) and potentially animal studies, compared against the known characteristics of predicate devices and general scientific principles for medical device design. It's not "ground truth" in the sense of expert-annotated data for an AI/ML model.
8. The sample size for the training set:
- Not Applicable. This is a traditional medical device, not an AI/ML device. There is no "training set" in this context.
9. How the ground truth for the training set was established:
- Not Applicable. See point 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.