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).

Device Description

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.

AI/ML Overview

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.

Endpoint (Acceptance Criteria)	Reported Device Performance (Success Rate)	Lower 95.81% Confidence Limit	p-value
Primary Effectiveness Objective:
Reduction in 24-hour pad weight (>50% reduction) at 6 months	88 out of 103 evaluable subjects (85.4%)	Not explicitly stated for this, implied by secondary statistical significance below	Not explicitly stated for this, implied by secondary statistical significance below
Secondary Effectiveness Endpoints:
Negative Cough Stress Test at 6 months	92.2% (95/103)	86.1%	<0.0001
≥ 50% reduction in UDI Score at 6 months	88.6% (93/105)	81.8%	<0.0001
≥ 50% reduction in IIQ Score at 6 months	93.3% (97/104)	87.4%	<0.0001
≥ 50% reduction in number of incontinence episodes at 6 months (Voiding Diary)	88.0% (81/92)	80.6%	<0.0001

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.

Summary

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Image /page/0/Picture/0 description: The image shows the Coloplast logo, which includes a circle with horizontal lines on the left and the word "Coloplast" in bold black letters on the right. Above the logo, there is the text "K121562" and "Page 1 of 3". The text is handwritten and appears to be part of a document or report.

510(K) SUMMARY

510(k) Owner's Name:	Coloplast A/S	NOV	5	2012
Address:	Holtedam 13050 Humlebaek, DenmarkEstablishment Registration: 9610694Owner/Operator: 8010144
Phone/Fax/Email:	Office: (612) 302-4922Mobile: (612) 703-6180Fax: (612) 287-4138
Name of Contact Person:	Janell ColleyRegulatory Affairs Manager
Date Prepared:	November 2, 2012
Trade or Proprietary Name:	Altis® Single Incision Sling System
Common or Usual Name:	Surgical mesh
Classification Name/Number/Product code:	Mesh, surgical, gynecologic, for stress urinaryincontinence, female, single-incision mini-sling/21 CFR 878.3300/PAH

Legally Marketed Device To Which Your Firm Is Claiming Equivalence:

The Coloplast Altis Single Incision Sling System (hereafter referred to as the Altis System) is substantially equivalent in performance, indications, design and materials to Coloplast's Aris System (previously Mentor's), cleared under premarket notification K050148 on March 9, 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on January 30, 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on November 20, 2009.

Device Description:

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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.

K121562

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Intended Use Of The Device:

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).

Technological Characteristics Compared To Predicate Device:

The Altis System is substantially equivalent in design, materials, performance characteristics, and indications to the predicates; Coloplast (formerly Mentor) Aris Mesh, cleared under premarket notification K050148 on 9 March 2005, American Medical System's MiniArc System, cleared under premarket notification K073703 on 30 January 2008 and C.R. Bard Ajust Adjustable Single Incision Sling, cleared under premarket notification K092607 on November 20, 2009.

The Altis, Aris, Ajust, and MiniArc Systems have the same intended use, mesh material (i.e., knitted polypropylene monofilament), introducer instrument for implantation provided with implant, sterilization method (i.e., ethylene oxide), and transobturator surgical approach. The Altis and Aris Systems use identical and introducer materials. The Altis, Ajust, and MiniArc Systems utilize polypropylene anchors and a single incision technique. The Altis and Ajust Systems have the following similarities: Altis and Ajust may be tensioned intraoperatively via a tensioning system connected to a tissue anchor; Altis and Ajust utilize helical type introducers which control positioning and placement of tissue anchors in the obturator space while avoiding the vascular and nerve bundles.

While the predicate Aris sling utilizes multiple incisions, the Altis, Ajust, and MiniArc systems use a single-incision surgical technique. The Altis and Ajust introducer radii are smaller than the Aris introducer radius, consistent with the difference in surgical approach. In terms of tensioning, the predicates have the following differences:

Aris is a full length sling that is placed using a relatively tension-free method I
. MiniArc is tensioned by pushing the anchors deeper into tissue; no further increase in tensioning is possible after introducers needles are removed and tension on the sling cannot be loosened if anchors are placed too deeply
. Ajust utilizes a tubular piece of mesh (attached to the sling) moving through its anchor to position the mesh beneath the urethra. When the physician has positioned the Ajust sling, a plug pre-positioned in the mesh tube is advanced using a stylet that is inserted to push the plug up the tube to limit the anchor mobilization.
. Altis utilizes suture attached to the sling that moves through the anchor in order to position the mesh beneath the urethra. When the physician has positioned the Altis sling, the tensioning system relies on compression force applied by the anchor/suture assembly to allow for precise positioning

Summary from the Nonclinical Tests Submitted:

Design verification (bench) testing was conduct on the Altis mesh and introducers and included the all recommended evaluations detailed in FDA's Guidance for Preparation of a Premarket Notification for a Surgical Mesh, including mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pullout strength, burst strength, tear resistance, device thickness, pore size, and burst strength. In addition, introducers were tested for pull out forces of needle from handle, torsion resistance of needle from handle, and handle diameter.

All testing results demonstrated acceptable results based on the established specifications.

Biocompatibility testing per ISO 10993 and per FDA 's Guidance for Preparation of a Premarket Notification Application for a Surgical Mesh was conducted on the Altis mesh and introducers, including cytotoxicity. sensitization, irritation, systemic toxicity (acute), genotoxicity, implantation (with histology of the surrounding tissue, hemolysis, pyrogenicity, heavy metals residuals, pyrogen levels

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All biocompatibility testing results demonstrated acceptable results based on the established specifications.

Simulated use evaluations were conducted in animals and human cadaveric laboratory testing per FDA Design Control requirements. All testing results demonstrated acceptable results based on the established specifications.

Summary from the Clinical Tests Submitted:

The clinical study of the Altis Sling System was a prospective, single arm, non-randomized, multi-center trial conducted at 17 sites in the US and Canada. The objective of the study was to assess safety and efficacy of the Altis single incision sling system for females with SUI. A total of 113 women were implanted with the Altis Sling. The median age for the women enrolled in the study was 54.5 years (range = 25.3 - 89.3). The median body mass index (BMI) was 29.9 (range = 20.0-55.8).

The study's primary effectiveness objective was improvement in subject continence status measured by reduction in 24-hour pad weight. At 6 months, 88 of 103 evaluable subjects showed >50% reduction in pad weight compared to baseline.

Secondary effectiveness endpoints included cough stress test (CST) at 6 months, assessment of subject Quality of Life (QOL) through validated questionnaires at 6 months, and voiding diaries were evaluated using performance goals. All results were statistically significant.

Endpoint	Success	Lower 95.81% CL	p-value
Cough Stress Test1	92.2% (95/103)	86.1%	<0.0001
UDI Score2	88.6% (93/105)	81.8%	<0.0001
IIQ Score3	93.3% (97/104)	87.4%	<0.0001
Voiding Diary4	88.0% (81/92)	80.6%	<0.0001
1Percent of subjects with negative cough stress test at 6 months2Percent of subjects with ≥ 50% reduction in UDI Score at 6 months³Percent of subjects with ≥ 50% reduction in IIQ Score at 6 months4Percent of subjects with ≥ 50% reduction in number of incontinence episodes at 6 months

	Results of CST, UDI-6, IIQ-7, and Voiding Diary
--	-------------------------------------------------	--	--	--	--

Device related events included 4 mesh extrusions (3.5%) and one case (0.9%) each of dypareunia, retention, UTI. inflammation, worsening OAB, and decreased urine stream. There were two device and/or procedure related serious adverse events: hematoma requiring hospitalization following a second sling revision due to urinary outlet obstruction, and a vaginal mesh extrusion for which explant surgery was indicated.

Conclusions

The Altis Sling system is substantially equivalent to its legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Date: November 5, 2012

Coloplast A/S % Ms. Janell A. Colley Regulatory Affairs Manager 1601 West River Road North MINNEAPOLIS MN 55411

Re: K121562

Trade/Device Name: Altis Single Incision Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: October 25, 2012 Received: October 26, 2012

Dear Ms. Colley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Janell A. Colley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda:gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner

for

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

2 ما 510(k) Number (if known): _ K 12 |5 ھا 2

Device Name:

Altis Single Incision Sling System

Indications for Use:

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).

Prescription Use X

Over-The-Counter Use

(Part 21 CFR 80T Subpart D) AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices

510(k) Number	K121562
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Altis Single Incision Sling System Traditional 510k 16 of 886

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.