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510(k) Data Aggregation
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
The Applied Alexis Wound Retractor is indicated for use to:
Access the abdominal cavity during surgery through an atraumatically retracted incision.
Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to:
Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an alraumatically-retracted incision.
The Coloplast Virtue Male Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.
The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large.
The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.
The submission K113496 by Coloplast A/S for the "Virtue Male Sling System with Alexis Wound Retractor" describes non-clinical testing to demonstrate substantial equivalence to its predicate devices. This 510(k) summary does not include any clinical studies, and therefore, does not provide information on acceptance criteria for device performance based on human studies, nor details like sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for such studies. It also does not involve AI.
Here's an analysis of the provided information, focusing on the non-clinical tests mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Established Design Specifications) | Reported Device Performance and Confirmation |
|---|---|
| Meet established design specifications for minor design modifications (decrease in mesh body, addition of suture knots). | Confirmed: Design verification testing and simulated use tests in a cadaveric laboratory confirmed that the modified Virtue System meets the established design specifications. |
| Biocompatibility requirements for the device materials. | Confirmed: Supported by previous biocompatibility testing for the original 510(k) (K041711) as there were no changes to materials. |
| Sterilization efficacy and sterility assurance level (SAL). | Confirmed: Existing sterilization validation supports the modified Virtue device as there were no changes to the sterilization method, SAL, or sterilization parameters. |
| Substantial equivalence to predicate devices (Virtue System K101297 and Alexis K041711) regarding intended use, design, materials, and scientific technology. | Confirmed: The non-clinical tests (design verification, simulated cadaveric use, previous biocompatibility, and sterilization validation) collectively support the conclusion that the Virtue Male Sling System with Alexis Wound Retractor is substantially equivalent to its predicate devices. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The "simulated use tests in a cadaveric laboratory" imply a sample size of cadavers, but the specific number is not provided.
- Data Provenance: The cadaveric laboratory testing would be considered prospective for the purposes of evaluating the design modifications. The location of the cadaveric lab is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as no clinical study or expert-adjudicated ground truth for device performance in humans was conducted. The non-clinical tests relied on engineering and scientific assessments.
4. Adjudication method for the test set
This information is not provided as it pertains to expert consensus in clinical studies, which were not conducted.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical sling and wound retractor, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this device is not an algorithm or AI system. Its performance is evaluated through physical tests and material properties.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by engineering design specifications and objective measurements gathered from the design verification testing, simulated cadaveric use tests, and established material and sterilization standards.
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" for this type of medical device.
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