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

The subject device is a surgical mesh. The proprietary mesh is supplied along with ancillary tools for placement of the device (convenience kit). The kit consists of: Minitape Urethral Sling (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; Disposable needle introducers, optionally used to aid in placement of the Minitape mesh; Polydioxanone absorbable sutures (CP Medical; Portland, OR), used to secure the mesh in place; Polypropylene suture bolsters (Ethicon Inc.; Sommerville, NJ), optionally used to aid in tightening ("snugging") the mesh following surgical placement.

This 510(k) summary (K091180) describes the Minitape Urethral Sling. However, the provided document does not contain acceptance criteria for device performance nor a detailed study that proves the device meets such criteria in terms of clinical effectiveness or specific quantitative measures.

Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily mentioning "in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use." This is a qualitative statement about the type of testing performed, not a report of results against specific performance metrics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to address the points based only on the provided information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The document mentions "in-vitro and in-vivo testing," but does not give details on the origin, nature (retrospective/prospective), or location of data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

5. Multi-reader multi-case (MRMC) comparative effectiveness study

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the provided document. The device is a surgical mesh, and the testing described is related to its mechanical properties and biological interaction, not to image interpretation or AI assistance for human readers.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study or AI component is mentioned.

6. Standalone (algorithm only without human-in-the-loop performance) study

• Standalone Study: Not applicable. This device is a surgical mesh; there is no algorithm or AI component described that would have a standalone performance. The testing mentioned (in-vitro, in-vivo) refers to the physical device itself.

7. Type of ground truth used

• Type of Ground Truth: Not explicitly stated in the context of specific performance metrics or clinical outcomes. The testing broadly "demonstrate[s] the ability of the device to adequately restrain urethral tissue." For "in-vivo" testing, this implies observation of physiological outcomes or biomechanical responses, but the method of establishing a definitive "ground truth" for success or adequate restraint is not detailed. For "in-vitro" testing, ground truth would likely be based on engineering measurements (e.g., tensile strength, elasticity).

8. Sample size for the training set

• Sample Size (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set. The device is a physical surgical implant.

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

• Ground Truth Establishment (Training Set): Not applicable, as there is no mention of an algorithm or AI requiring a training set.

Summary of Missing Information:

The provided 510(k) summary document for the Minitape Urethral Sling primarily focuses on establishing substantial equivalence to predicate devices and generally describing the types of testing performed. It explicitly states: "The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use."

However, it does not provide any specific quantitative acceptance criteria or detailed results from these tests, nor does it describe specific study methodologies (like sample sizes, expert involvement, or adjudication) that would be typically found for performance studies. This is often the case in 510(k) summaries where the detailed test reports are part of the full submission but not included in this public summary.

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

The subject device is a totally disposable tape 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. It consists of a polypropylene tape with integral fixation zones on either side of a central mesh sling. These fixation zones at the ends of the tape anchor the sling to surrounding soft tissues.

The provided text is a 510(k) summary for the "Modified Minitape* Urethral Sling" and primarily discusses regulatory information, device description, and indications for use. It briefly mentions "in-vitro and in-vivo testing" that "demonstrate the ability of the device to adequately restrain urethral tissue," but it does not contain the detailed information required to answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert qualifications.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information based on the provided text. The document states that testing was performed, but it does not describe the specific study (or studies), their methodologies, or their results in a way that allows for the extraction of the requested information.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative or qualitative acceptance criteria for device performance.
• Sample sizes (test set), data provenance: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth: Not mentioned, although for a physical device like a sling, "ground truth" would likely relate to clinical outcomes, physiological measurements, or imaging post-implantation, none of which are detailed here.
• Sample size for training set: Not applicable as this is a physical medical device, not an AI algorithm.
• How ground truth for training set was established: Not applicable as this is a physical medical device, not an AI algorithm.

The core of the provided document is the 510(k) regulatory submission, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed scientific study report.

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