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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 atraumatically-retracted incision.

The Virtue Male Sling is an implantable, suburethral support sling intended for the surgical treatment of male stress urinary incontinence (SUI). The four-arm design of the Virtue Male Sling provides a dual mechanism of action by providing both compression of the bulbous urethra and proximal urethral elevation. The Virtue Male Sling is constructed of non-absorbable medical grade knitted, monofilament polypropylene and is intended to be permanently implanted.

The Virtue Introducer is used to facilitate transobturator and pre-pubic passages during the surgical placement of the Virtue Male Sling. The introducer is manufactured from polycarbonate thermoplastic elastomer (handle) and medical grade stainless steel (needle). The Virtue Introducer is only to be used with the Virtue Male Sling System in accordance with the Instructions for Use.

The Virtue Male Sling System with Alexis Wound Retractor includes one (1) Virtue Male Sling, one (1) single-use Virtue Introducer and one (1) Alexis Wound Retractor intended to facilitate the placement of the Virtue Male Sling.

The provided FDA 510(k) summary (K231891) for the Virtue Male Sling System with Alexis Wound Retractor indicates that performance data was not necessary for the substantial equivalence determination.

Therefore, the document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The conclusion is based on the subject device having:

• Identical intended use
• Identical target population
• Identical sterilization technique
• Identical biocompatibility features
• Identical overall device design features
• Identical duration of use

compared to its predicate device (K113496, also the Virtue Male Sling System with Alexis Wound Retractor). The submission focused solely on revised labeling, which included:

• Adding a contraindication to align with other Coloplast mesh Instructions for Use (IFU) manuals.
• Updating adverse events based on post-market surveillance and literature analysis.
• Updating procedure details aligned with current literature.

The FDA determined that these labeling changes "do not raise questions of safety or effectiveness."

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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

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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The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries.

The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711) :

• l Access the abdominal cavity during surgery through an atraumatically retracted incision.
• 피 Delivery maximum exposure of the abdominal cavity with minimum incision size.
• 트 Protect against wound contamination during laparoscopic and open surgery.
• . Seal off the incision opening to permit insufflating the peritoneum.
• 트 Convert the incision wound to an additional trocar port site.
• 트 Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings.

To perform these functions, Alexis Wound Retractors are 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 also includes an incision template.

The Wound Retractor is simple to set up and easy to use. A sterile skin marker is used to mark an incision line at the surgery site and the incision is made. The Wound Protecting theath is placed in position through the incision with one ring inside the abdomen. The external ing is placed in traction and folded over itself until it contacts the abdomen. Once securely in place, the Alexis Wound Refractor keeps the incision open during the procedure. The wound protective sheath lines the incision and protects against wound contamination during the procedure.

The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch, which is standard packaging material for Applied's products. The packaged product is then placed in an outer product shelf pack.

The provided text is a 510(k) summary for the Alexis® Wound Retractor, a device used for surgical retraction and wound protection. It does not contain a study demonstrating that the device meets specific acceptance criteria in the way typically found for diagnostic algorithms or devices with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on substantial equivalence to a predicate device, and the "acceptance criteria" are related to biocompatibility, material properties, and sterility, which are standard for a medical device of this type.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• For the material and biocompatibility testing, specific sample sizes are not mentioned in the document. These tests are typically performed on a statistically relevant number of samples to demonstrate compliance with standards.
• Data provenance is not explicitly stated, but it can be inferred that these tests were conducted internally by Applied Medical Resources Corporation or by a qualified third-party testing facility under their direction, as part of the device development and regulatory submission process. These are laboratory-based tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in the context of this device and submission. The "ground truth" here is compliance with established physical, chemical, and biological safety standards (e.g., ISO, ASTM). These standards define the test methods and acceptance criteria, rather than requiring expert consensus on a diagnostic outcome. Experts involved would be those qualified to execute and interpret these standard tests (e.g., toxicologists for biocompatibility, materials scientists for mechanical properties, microbiologists for sterility validation).

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies comparing diagnostic interpretations, not for physical device property testing. Compliance is determined by whether the test results meet the predefined numerical or qualitative criteria of the respective standards.

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. This is a physical surgical device, not a diagnostic AI or imaging interpretation tool. Therefore, an MRMC study is not relevant.

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

• No. This is a physical surgical device. The concept of an "algorithm only" or "standalone" performance without human-in-the-loop is not applicable here. Its function is to be used by a human surgeon.

7. The type of ground truth used

• The "ground truth" for this device's acceptance is based on compliance with recognized international and national standards for:
  • Biocompatibility: ISO 10993 (biological safety).
  • Material Properties: ASTM D 412 (tensile strength, elongation) and ASTM D 624 (tear strength).
  • Sterility Validation: ANSI/AAMI/ISO 10993-7 (sterilant residues) and principles for achieving a 10⁻⁶ SAL (e.g., "three half-cycle validation runs").
  • Functional Adequacy: Demonstrated by "functional performance testing" (details not provided, but implies it mechanically performs its intended role).
• Ultimately, the overarching "ground truth" for regulatory clearance is substantial equivalence to an already legally marketed predicate device, demonstrating that it is as safe and effective.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a "training set."

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

• Not applicable. No training set is involved.

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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 size.
• 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 through an atraumatically-retracted incision.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The extra-small, small and medium products will have two additional indications. These models have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar. The procedure may then be returned to fully laparoscopic and an additional trocar may be placed through the incision site. The Wound Retractor package also includes an incision template. The Applied Wound Retractor is a disposable, single-use device and is packaged inside a Tyvek/Mylar peel pouch.

This 510(k) summary for the Alexis™ Wound Retractors does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the format you've outlined for performance studies of AI/diagnostic devices.

Instead, this document describes a traditional medical device (wound retractor), and its clearance process is based on substantial equivalence to a predicate device, rather than a performance study with defined sensitivity/specificity metrics.

Here's a breakdown of what is provided and why it doesn't fit your requested format:

What's in the document that relates to device evaluation (though not in your requested format):

• Biological Evaluation: "The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part I: Biological Evaluation of Medical Devices." This is a pass/fail criterion for biocompatibility, not a performance metric like sensitivity or AUC.
• Material Testing: "The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624)." These are material property tests, again with pass/fail criteria.
• Functional Performance Testing: "Functional performance testing has been completed and has passed the required testing." This is a very general statement, indicating the device performs its intended functions (retraction, protection). The specific acceptance criteria and results are not detailed here.
• Sterilization Validation: "Applied's 100% EO sterilization cycle provides a sterility assurance level of 10⁻⁶." This is a specific performance metric for sterility.

Why this document doesn't provide the requested information for an AI/diagnostic device performance study:

1. Nature of the Device: The Alexis™ Wound Retractor is a physical surgical tool, not an AI algorithm or a diagnostic test that generates quantitative results (like a score or a classification) requiring metrics such as sensitivity, specificity, or AUC.
2. Regulatory Pathway: This device was cleared through the 510(k) pathway based on substantial equivalence to a predicate device (Heartport Soft Tissue Retractor). This means the FDA determined it is as safe and effective as a legally marketed device, circumventing the need for extensive clinical trials or complex performance studies generally associated with novel diagnostics or AI. The argument is that it "introduces no new safety or effectiveness issues."
3. Lack of AI/Diagnostic Metrics: The document doesn't discuss "ground truth," "expert consensus," "sample sizes for test/training sets," "MRMC studies," or "standalone performance" because these concepts are not applicable to the physical wound retractor's clearance.

Attempting to map the available information to your requested structure, acknowledging its limitations:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• This is not applicable as it's not a diagnostic/AI study. Testing for biological evaluation, material properties, and functional performance would have involved a sufficient number of device samples or components according to the respective standards, but a "test set" in the context of image data or patient outcomes is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There is no "ground truth" to be established by experts in this context. Rather, compliance with engineering and biological standards is assessed.

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

• Not applicable.

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:

• Not applicable. This is not an AI/diagnostic device. The clearance is based on substantial equivalence to a predicate device, implying similar effectiveness without a comparative clinical study in this submission.

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

• Not applicable.

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

• Not applicable. The "ground truth" for this device's safety and effectiveness is compliance with recognized standards (ISO, ASTM) and demonstrated equivalence to a predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

In summary, the provided document describes the regulatory clearance of a conventional medical device via the 510(k) pathway, focusing on substantial equivalence and compliance with established engineering and biocompatibility standards, rather than performance metrics typically associated with AI or diagnostic evaluations.

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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 size.
• Protect against wound contamination during laparoscopic and open surgery.
  The smaller two sizes of Alexis are also intended to be used to:
• Scal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.

The Applied Wound Retractor consists of a flexible polymer membrane formed into the shape of a cylinder. Attached to each open end of the cylinder are two semi-rigid polymer rings. The rings are molded in a plastic material. The Wound Retractor package also includes an incision template. The device will be manufactured in four sizes, small, medium-large and large. The small and medium products will have an iris valve feature that allows the wound protector to be adjusted from fully open to fully closed. This capability allows Alexis to seal the incision area or to seal around a trocar.

The provided 510(k) summary for the Alexis™ Wound Retractor describes a medical device and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria from an AI/algorithm performance perspective.

This document is for a physical medical device (a surgical wound retractor), not a software or AI-powered device. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.

Instead, the submission focuses on the biological safety, material properties, and functional performance of the physical device, and its sterilization process, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text based on the questions, acknowledging that the focus is on a physical medical device:

Analysis of the Provided Information

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

The document doesn't present a formal table of acceptance criteria with numerical performance metrics as would be expected for an AI/algorithm. However, it does state that the device underwent specific tests and "passed" or "complied" with relevant standards:

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 applicable as the device is a physical surgical retractor, not a software or AI-powered diagnostic/analytic tool that processes data from a test set. The "testing" referred to is for material and functional properties, not data analysis.

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 for the same reasons as above. "Ground truth" in the context of this device would refer to the successful operation of the device in a clinical setting, which is inferred from its design and material testing, not from expert review of data.

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

This is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, which is not part of the submission for a physical device like this.

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. An MRMC study is used for evaluating diagnostic performance (often of imaging devices or AI algorithms). This device is a surgical tool, not a diagnostic one, and does not involve "human readers" or AI assistance in decision-making.

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

This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a physical surgical retractor.

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

As it's a physical device, the "ground truth" for its performance is assessed through physical and chemical testing standards, not clinical pathology or outcomes data in the sense of a diagnostic device. The "ground truth" that the device effectively retracts and protects wounds is supported by its design and material properties, and its substantial equivalence to a predicate device that is already cleared for such functions.

8. The sample size for the training set

This is not applicable as there is no AI algorithm being trained.

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

This is not applicable as there is no AI algorithm being trained.

In summary: The provided text details the regulatory submission for a physical medical device (a wound retractor). The "acceptance criteria" and "studies" mentioned relate to the device's material properties, biocompatibility, sterilization, and functional design, ensuring it meets safety and effectiveness standards, primarily through conformance to established ISO and ASTM standards and demonstrated substantial equivalence to a legally marketed predicate device. The questions posed are primarily relevant to AI/software as a medical device submissions.

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