(76 days)
The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
The AMS Elevate System is a modification of the Apogee System, part of the AMS Pelvic Floor Repair System family of devices. It consists of a permanently-implanted mesh sling assembly and non-implantable surgical instruments that can be used as aids to place the mesh sling assembly in the pelvic floor. The sling assemblies are made from polymeric mesh, or a combination of polymeric mesh and surgical mesh derived from porcine dermis.
This is a medical device application for a surgical mesh, not an AI/ML powered device. As such, the requested information regarding AI/ML device performance, study design, and ground truth establishment is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing of the device components.
Here's a breakdown of the available information based on your request, highlighting what's missing due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics for the AMS Elevate™ System beyond a general statement of "biocompatibility and performance requirements."
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds or quantitative measures in the provided text.
- Reported Device Performance: The summary states: "The components of the AMS Elevate Prolapse Repair System have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate device." This is a qualitative statement of equivalence, not a detailed performance report against specific criteria.
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 because the device is a surgical mesh, and its evaluation relies on material biocompatibility and mechanical performance testing, rather than a clinical study with a "test set" of patient data in the context you're implying for AI/ML.
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)
This is not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML models that interpret data (like images). For a surgical mesh, the "ground truth" would be established through material science testing and clinical outcomes, which are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a surgical mesh device.
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 for AI/ML devices that assist human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the specific ground truth types in detail for the component testing. For "biocompatibility," the ground truth would be established by standardized assays and biological responses according to ISO standards or similar. For "performance requirements," it would involve mechanical testing against established material specifications and potentially in-vitro or ex-vivo models, but details are not provided.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable.
In summary: The provided document is a 510(k) summary for a surgical mesh device. The core of its regulatory submission centers on demonstrating substantial equivalence to a previously cleared predicate device (AMS Pelvic Floor Repair System K051485) through biocompatibility and performance testing of its components. The concept of "acceptance criteria" for an AI/ML model, "test sets," "ground truth" adjudicated by experts, and "MRMC studies" are not relevant to this type of medical device submission.
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.