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I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes a medical device, the I-STOP® Trans Obturator Male / Female Sling, and states that it underwent "Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests" as well as "Three studies on this surgical technique and three anatomical studies." However, it does not provide specific acceptance criteria, performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement in a way that aligns with your request for AI/algorithm performance studies.

Therefore, I cannot generate the requested table and fully answer all questions as the provided text is primarily a 510(k) notification for a surgical mesh device, not a study evaluating an AI/algorithm's performance.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document discusses compatibility with ISO 10993 for biocompatibility and mentions "mechanical tests" and "chemical tests," but it does not specify acceptance criteria for these tests nor does it report detailed performance results against such criteria in a quantifiable manner. It also mentions "clinical tests" and "anatomical studies," but again, no specific acceptance criteria or performance results are detailed.

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

• Cannot be provided. The document states "Three studies on this surgical technique and three anatomical studies," but provides no details on sample sizes, study design (retrospective/prospective), or data provenance for these studies.

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)

• Cannot be provided. This information is typically relevant for studies involving subjective assessments or interpretation (like imaging studies) where human experts establish ground truth. As this is a surgical mesh device, the "ground truth" would likely relate to objective clinical outcomes or mechanical properties, not expert interpretation in the way relevant for AI performance studies. The document does not discuss expert involvement in establishing ground truth for any tests.

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

• Cannot be provided. Not applicable given the nature of the device and the lack of AI-specific performance evaluation.

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

• Cannot be provided. This document is for a physical surgical device, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant or described.

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

• Cannot be provided. Not applicable, as this is not an algorithm or AI device.

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

• Cannot be provided. The document does not specify the ground truth used for its "clinical tests" or "anatomical studies." For a surgical mesh, ground truth for clinical studies would typically be patient outcomes (e.g., continence rates, complication rates) or histological analysis (for biocompatibility).

8. The sample size for the training set

• Cannot be provided. The concept of a "training set" applies to machine learning and AI algorithms. This device is a physical surgical implant.

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

• Cannot be provided. Not applicable, as this is not an AI/algorithm device.

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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.

Study Details (as inferable from the text, primarily noting absence of AI/ML specific details)

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. The sample size for the training set:

   • Not applicable/Not specified. This device does not involve a "training set" in the AI/ML sense.

8. 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.

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I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

I-STOP is a sterile, single use kit consisting of knitted monofilament polypropylene, two to four stainless steel needles and two polycarbonate handles. The kit is designed to be used with any of the surgical approaches to position the sling.

The provided text describes a medical device called I-STOP, a surgical mesh intended for the treatment of female urinary incontinence. However, it does not contain specific acceptance criteria, reported device performance metrics in a quantifiable way, or details of a study that proves the device meets those criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria through clinical studies with quantitative outcomes.

Here's a breakdown based on the information provided, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically involve specific quantifiable targets for safety and effectiveness (e.g., success rate, complication rates, tensile strength, erosion rates).
• Reported Device Performance: Not provided in a quantifiable manner. The summary mentions "Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests" and "One multicenter retrospective study on a large population, published on Urology (January 2000) and one march and published soon." However, no specific results, success rates, or complication rates are reported from these studies to compare against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not specified. The document mentions "one multicenter retrospective study on a large population." "Large population" is not a specific sample size.
• Data Provenance: "One multicenter retrospective study" is mentioned. The country of origin is not specified but the submitter is based in France. The study is explicitly stated to be retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided. The retrospective study mentioned would have involved patient outcomes as "ground truth," but details about expert involvement in establishing this are absent.

4. Adjudication Method for the Test Set:

• This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC study is mentioned. This device is a surgical implant, not an imaging or diagnostic AI-assisted device, so an MRMC study in the typical sense (comparing human readers with and without AI assistance for interpretation) would not be applicable.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical surgical implant, not a software algorithm.

7. Type of Ground Truth Used:

• Based on the context of a retrospective clinical study for a surgical implant, the ground truth would typically be patient clinical outcomes (e.g., resolution of urinary incontinence, occurrence of complications) as observed and recorded in patient medical records over time.

8. Sample Size for the Training Set:

• Not applicable/provided. There is no mention of an algorithm or AI model requiring a training set. The clinical study described is for evaluating the implant's effectiveness in patients, not for training a model.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the detailed performance metrics, acceptance criteria, or specific study designs (like MRMC or AI training/testing details) that would be expected for a software-as-a-medical-device (SaMD) or an AI-enabled device. The "Summary of clinical tests" section is very brief and lacks quantitative results.

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