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Omnisure™ Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Omnisure™ Urethral Sling is a surgical mesh intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The proprietary mesh is supplied along with ancillary tools for placement of the device. The device is supplied sterile.

The provided text describes a 510(k) premarket notification for the "Omnisure™ Urethral Sling" by Mpathy Medical Devices, Ltd. This submission is for a surgical mesh, which is a physical device, not a digital health product or an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance metrics like sensitivity, specificity, or AUC, as commonly applied to AI/ML devices, is not directly applicable here.

Instead, for a physical medical device like a surgical mesh, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, technological characteristics (materials, design, fundamental scientific technology), and performs comparably in terms of safety and effectiveness.

Here's how the provided information addresses your request, framed within the context of a physical medical device:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly list "acceptance criteria" in the quantitative sense of an AI/ML device. Instead, the core "acceptance criterion" for a 510(k) is substantial equivalence to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided documents do not detail a "test set" in the context of a clinical performance study with a specific sample size. For a 510(k) of this nature, clinical studies with detailed sample sizes and data provenance are often not required if substantial equivalence can be demonstrated through other means (e.g., comparison of materials, design, and non-clinical testing). The key testing mentioned is "biocompatibility and mechanical testing" which are laboratory-based and do not typically involve human "test sets" with specified provenance.

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 to this 510(k) submission. "Ground truth" in the context of AI/ML evaluation (established by experts) is not relevant for demonstrating substantial equivalence of a physical surgical mesh.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this 510(k) submission as there is no mention of a "test set" requiring expert adjudication.

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 is not applicable. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human interpretation, often with AI assistance. This submission is for a surgical mesh, not a diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for demonstrating safety and effectiveness is typically established through:

• Predicate device's safety and effectiveness history: The predicate devices (Minitape® Extra Urethral Sling, SPARC Sling System, TVT) have established safety and effectiveness through their prior market clearance and clinical use.
• Non-clinical testing: "biocompatibility and mechanical testing" for the Omnisure™ device itself, demonstrating that its properties are comparable to the predicate.
• Clinical experience (if any) with similar materials/designs: Implied by the substantial equivalence argument, leveraging existing knowledge of surgical meshes.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is not an AI/ML algorithm requiring a training set.

In summary: The provided 510(k) notification for the Omnisure™ Urethral Sling demonstrates that it meets the "acceptance criteria" (i.e., criteria for substantial equivalence to a predicate device) by asserting that it has the same intended use, general design, material, and fundamental scientific technology as the predicate device (Minitape® Extra Urethral Sling, K073647). This claim is supported by the fact that the components of the Omnisure™ device have undergone biocompatibility and mechanical testing to confirm their equivalence to the predicate. The FDA's issuance of the substantial equivalence letter (K092203) signifies that the device has met these regulatory "acceptance criteria."

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