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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 Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only.

The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent.

The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use.

The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted.

Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling.

The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only.

The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted.

The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

No information regarding acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML powered medical device, as described in the prompt's requested information points (1-9), is available in the provided text.

The document discusses the substantial equivalence (510(k) clearance) of a physical medical device: the Altis Single Incision Sling System, Aris Transobturator Sling System, and Supris Retropubic Sling System, which are surgical meshes for treating stress urinary incontinence.

The "Performance Data" section (VII) lists various bench testing conducted to support the substantial equivalence determination for changes to the mesh material, including:

• Biocompatibility Testing (ISO 10993-1)
• Performance Testing (Mesh Density, Thickness, Pore Size, Sling Length, Width, Tensile Strength, Elongation at Break, Elasticity, Stiffness, Suture Pull-Out Strength, Mesh Tear Resistance, Suture/Mesh Weld Strength, Shelf-life testing)
• Sterilization (Ethylene Oxide)
• Packaging and Distribution

The document explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices." This confirms that there was no human reader study, no standalone algorithm performance, or any of the other AI/ML specific criteria mentioned in the prompt.

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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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The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.

NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.

The provided text describes a medical device, the Mentor NovaSilk™ Mesh, and its clearance process through the FDA 510(k) pathway. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than explicit performance against predefined acceptance criteria for AI/ML devices or diagnostic accuracy. Therefore, much of the requested information for an AI/ML device is not applicable or not present in this document.

Here's an analysis based on the information provided and what is typically sought for AI/ML device evaluations:

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

For this device (surgical mesh), the "acceptance criteria" are not reported in terms of specific performance metrics like sensitivity, specificity, accuracy, or AUC that would be relevant for an AI/ML diagnostic or predictive device. Instead, acceptance for 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device and meeting general safety and effectiveness requirements through various tests.

The document lists the following characteristics assessed for NovaSilk:

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

This information is not provided. The testing described appears to be bench testing for material characteristics and biocompatibility, not a clinical study with patient "test sets" in the context of AI/ML evaluation.

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. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth.

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

This is not applicable. The device is a surgical mesh, not a diagnostic tool requiring adjudication of interpretations.

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. The device is a surgical mesh, not an AI-assisted diagnostic tool.

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

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

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

This is not applicable. The "ground truth" for this device would be its physical and biological properties conforming to established standards and demonstrating safety. The biocompatibility tests for pyrogenicity and cytotoxicity provide a form of "ground truth" regarding its biological safety.

8. The sample size for the training set

This is not applicable. The device is a manufactured medical product, not an AI/ML model that requires a training set.

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

This is not applicable.

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The Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Mentor Aris Suprapubic Surgical Kit consists of two components: the Mentor Aris Sling and a set of Introducers. The Mentor Aris Sling is an implantable, suburcthral, support tape made from knitted monofilament polypropylene fibers. Two sterile, disposable flat curved Introducers necessary for implantation of the sling are also included in the Surgical Kit. The Introducers consist of a stainless steel needle with a plastic handle.

The Mentor Aris™ Suprapubic Surgical Kit is a medical device for the surgical treatment of stress urinary incontinence. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study report.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for the testing described for the Aris Introducers. It generally states that "testing was performed."

The data provenance is not explicitly mentioned but typically in 510(k) submissions, testing is performed by the manufacturer or contracted labs. The studies listed are laboratory-based performance and biocompatibility tests, not clinical studies with human subjects.

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

This information is not applicable. The "ground truth" here refers to established standards (e.g., ISO guidelines for biocompatibility, engineering specifications for mechanical performance), not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" are relevant for clinical studies or evaluations involving human interpretation. The testing described is objective laboratory testing against predetermined specifications.

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

No, an MRMC comparative effectiveness study was not done. The device is a surgical kit, not an AI software or diagnostic tool that would involve human readers or image interpretation.

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 kit, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the testing described is based on:

• International Standards: Specifically, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (intracutaneous reactivity) for biocompatibility.
• Engineering Specifications/Performance Characteristic Specifications: For the mechanical and physical properties of the Introducers (e.g., sling pull-out force, torque, tensile performance, flexure, stiffness). These specifications are set by the manufacturer to ensure the device performs as intended.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This is not applicable as there is no training set for this device.

Overall Study Information:

The "study" presented in this 510(k) summary is a set of tests designed to demonstrate that the Mentor Aris Suprapubic Surgical Kit (specifically the Introducers, as the Sling was previously cleared) meets established safety and performance requirements and is substantially equivalent to predicate devices. These tests include:

• Biocompatibility Testing of Aris Introducers: Cytotoxicity per ISO 10993-5 and intracutaneous reactivity per ISO 10993-10. These tests determine if the device materials are harmful to biological systems.
• Performance Testing of Aris Introducers: This involved evaluating the mechanical integrity and functionality of the Introducers, including:
  • Sling pull-out force from the eyelet
  • Torque and tensile performance of the handle/needle interface
  • Needle flexure characterization
  • Needle stiffness characterization

The results of these tests confirmed the Introducers are "non-toxic and non-irritants" and "meet the required performance characteristic specifications for the intended use of the instruments," supporting the claim of substantial equivalence. The document does not provide raw data, specific numerical thresholds for "acceptance criteria," or detailed test methodologies beyond the standard names mentioned.

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