(68 days)
The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.
This document describes a 510(k) premarket notification for the I-STOP™ Mid-Urethral Sling, asserting its substantial equivalence to a predicate device, the Tension Free Vaginal Tape (TVT) System.
Based on the provided text, the device's acceptance criteria and the study proving it meets these criteria are not explicitly defined in a quantitative manner typical for AI/ML device evaluations. This is a traditional medical device submission, not an AI/ML device submission, and therefore, the information requested for AI/ML performance metrics (such as sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication methods, or MRMC studies) is largely not applicable and not present in the given text.
The document focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria often seen for novel AI/ML diagnostics.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the regulatory standard of "substantial equivalence" to the predicate device. This means the new device must be as safe and effective as the predicate. The "reported device performance" is qualitative and based on clinical experience and biocompatibility testing rather than specific quantitative metrics.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (from text) |
|---|---|
| Intended Use Equivalence | "The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." - Matches predicate's likely intended use. |
| Technological Characteristics Equivalence | "The new and predicate devices are technologically the same; they are polypropylene meshes implanted with stainless steel needles to provide urethral support for females patients with SUI." |
| "The devices have similar implantation, sterilization, and storage requirements." | |
| Safety | "Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling." |
| Effectiveness | "Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended." |
| No new questions of safety or effectiveness | "In the few instances where the devices differ, no additional concerns about safety or effectiveness are raised." |
Study Details (as inferable from the text, primarily noting absence of AI/ML specific details)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "Clinical experience with the I-STOP device" but does not provide details on the sample size, study design (retrospective/prospective), or data provenance for any specific clinical test set. This type of detail is not typically required for a 510(k) submission based on substantial equivalence when performance is demonstrated qualitatively and through biocompatibility.
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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/Not specified. This is not an AI/ML diagnostic device where a ground truth for a test set would be established by experts in this manner. The performance is based on clinical outcomes and engineering principles.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As above, this concept pertains to AI/ML evaluations for diagnostic accuracy.
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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:
- No. This is a surgical implant device, not an AI-assisted diagnostic tool. MRMC studies are not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "truth" for this medical device's performance would be considered clinical outcomes data (success/failure in treating SUI, safety profile, absence of significant complications) and biocompatibility testing results. Specific details on how this "truth" was collected or adjudicated are not provided in this summary.
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The sample size for the training set:
- Not applicable/Not specified. This device does not involve a "training set" in the AI/ML sense.
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How the ground truth for the training set was established:
- Not applicable/Not specified. As above, no training set for AI/ML.
In summary, the provided document is a 510(k) submission for a non-AI surgical implant, focusing on regulatory substantial equivalence. It does not contain the detailed quantitative performance study information, expert qualifications, or ground truth methodologies typically associated with AI/ML diagnostic or assistive devices. The regulatory approval is based on the device's similarity to an already approved predicate device and general safety/effectiveness demonstrated through clinical experience and biocompatibility.
§ 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.