(70 days)
The Smart Sling System is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The AMS Smart Sling System consists of a sling and a surgical instrument (called a "Needle Passer" or Surgical Needle Instrument") for sub-urethral sling placement. The slings are made from polymeric mesh.
This document describes the AMS Smart Sling System, a surgical mesh device intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI). The provided text is a 510(k) summary statement and a subsequent FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices rather than reporting on specific acceptance criteria and a detailed study proving the device meets those criteria.
Therefore, much of the requested information cannot be definitively extracted from the provided text. The document does not contain specific acceptance criteria with numerical targets for device performance or a detailed study report demonstrating the device meets such criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The submission focuses on substantial equivalence, which implies the device performs comparably to legally marketed predicate devices, but it does not specify explicit performance metrics or acceptance criteria for the AMS Smart Sling System itself.
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 present in the provided document. The document mentions "bench and biocompatibility testing, cadaver studies and a literature review" as supporting information. However, no details about sample sizes, data provenance (country, retrospective/prospective nature), or specific study designs are provided.
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 information is not present in the provided document. Since specific clinical studies with a "test set" and "ground truth" are not detailed, there's no mention of experts or their qualifications in this context. The "cadaver studies" might involve expert assessment, but no details are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document.
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 present in the provided document. The AMS Smart Sling System is a surgical mesh device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided document. As mentioned, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document. While the device's efficacy would ultimately be measured by patient outcomes (reduction in SUI symptoms), the provided submission focuses on pre-market clearance based on substantial equivalence, not on detailed clinical trial results with established ground truth types for a specific test set.
8. The sample size for the training set
This information is not present in the provided document. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this device.
9. How the ground truth for the training set was established
This information is not present in the provided document. As above, the concept of a "training set" and its ground truth is not applicable.
Summary of available information related to "study" and "evidence":
The supporting information mentioned for the substantial equivalency determination includes:
- Previously cleared and new bench and biocompatibility testing: This refers to laboratory tests on the material and mechanical properties of the sling and its components, as well as tests to ensure it's safe for use in the body. No specific results, sample sizes, or acceptance criteria for these tests are provided.
- Cadaver studies: These studies would involve the use of human cadavers to evaluate the surgical technique and placement of the sling. No details on the number of cadavers, the specific protocol, or findings are given.
- A literature review: This would involve reviewing existing scientific publications related to similar surgical meshes and procedures. This supports the general understanding and safety profile but is not a direct study on the specific device's performance.
In conclusion, the provided FDA document is a 510(k) summary that emphasizes substantial equivalence to predicate devices through various forms of non-clinical testing and literature review. It does not present a detailed study with explicit acceptance criteria and corresponding performance data that directly answers the specific questions about typical clinical study parameters.
§ 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.