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The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Altis System is a single-incision mini-sling.. The sling material is manufactured using the commercialized Aris polypropylene mesh (K050148). Altis sling is made of a 0.08mm (nominal) diameter monofilament polypropylene mesh, knitted into a sling 1.1 cm wide by 7.75 cm long. One end of the sling assembly connects to a short length of USP size 1 monofilament polypropylene suture and to a polypropylene static (non-tensioning) anchor. The second side of the sling assembly terminates to a longer section of USP size 1 monofilament polypropylene suture. This suture is then positioned through the second anchor that is dynamic with an integrated tensioning system. The tensioning capability is accomplished by threading the suture through a polyurethane tensioning collar which is assembled onto the anchor. The anchor/suture assembly wraps around the anchor, resulting in a gap between the anchor and the collar providing constant pressure on the suture, preventing it from moving on its own, or during a pelvic stress event. Tensioning is achieved by pulling on the suture loop, thus applying increased tension of the sling to the urethra until desired support is achieved. The Altis anchors perform an acute mechaning the desired position and tension through the acute post-operative tissue healing and in-growth phase, The Altis sling assembly is packaged with two (2) helical type introducers (one right, one left) that are used to place the sub-urethral sling. The Altis introducers are designed with the appropriate curvature and length to reach the obturator foramen through a single vaginal incision. The tip of the needle is designed to fit into the anchors to facilitate placement into the obturator foramen during the surgical implant procedure. The sling assembly pouch and introducers are placed in a tray sealed with a Tyvek lid. The Altis system (implant plus introducers) is provided sterile (ethylene oxide) and is for single use only.

Here's a breakdown of the acceptance criteria and study information for the Coloplast Altis® Single Incision Sling System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study to assess safety and efficacy. The acceptance criteria are essentially derived from the primary and secondary effectiveness objectives of this study. The reported performance is the "Success" rate for each endpoint.

Note: The document states that "All results were statistically significant" for the secondary effectiveness endpoints, implying that the observed success rates met the predefined statistical thresholds. The "Lower 95.81% CL" provides a statistical indication of the minimum expected performance. For the primary objective (pad weight reduction), the raw number of subjects meeting the criteria is given, but a specific confidence limit or p-value is not directly tabulated for it, though the overall study concludes successful equivalence.

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

• Sample Size (Clinical Test Set): 113 women were implanted with the Altis Sling. Out of these, 103 were evaluable for the primary effectiveness objective, and slightly varying numbers for secondary endpoints (e.g., 103 for CST, 105 for UDI, 104 for IIQ, 92 for Voiding Diary).
• Data Provenance: The study was a prospective, single-arm, non-randomized, multi-center trial conducted at 17 sites in the US and Canada. This indicates prospective data from North America.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly mention "experts" being used to establish ground truth in the context of adjudication for the effectiveness endpoints. The ground truth for effectiveness measures like pad weight reduction, cough stress test results, and patient-reported outcomes (UDI, IIQ, voiding diary) are typically obtained directly from patient data collection by clinical staff and validated questionnaires, not through expert consensus on individual cases for the purpose of algorithm evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the study is a direct clinical trial assessing patient outcomes, typical "adjudication methods" like 2+1 or 3+1 are more common for subjective assessments or image interpretations in AI studies. For objective clinical endpoints, data collection protocols and standard clinical assessments would serve this purpose rather than a separate adjudication process as defined in AI studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a single-arm clinical trial evaluating the device's performance directly, not comparing human readers with and without AI assistance.

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

Not applicable/No. The Altis Single Incision Sling System is a medical device (surgical mesh), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply to this device. The clinical study assessed the device's performance in patients.

7. The Type of Ground Truth Used

The ground truth used in this clinical study consisted of:

• Objective clinical measurements: 24-hour pad weight reduction, Cough Stress Test results.
• Patient-reported outcomes (PROs): Scores from validated questionnaires (UDI, IIQ) and Voiding Diaries.
• Safety data: Device-related adverse events and serious adverse events.

This is essentially patient outcomes data collected directly during a clinical trial.

8. The Sample Size for the Training Set

This information is not applicable as the document describes a medical device, not an AI model that requires a training set. The clinical study population of 113 women served as the test population for device performance.

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

This information is not applicable as the document describes a medical device, not an AI model that requires a training set.

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