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The Self Cath® Catheter is intended for use in male, female, and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Self Cath Catheter consists of a flexible PVC tube. One end of the tube has two holes (eyelets) punched into the tube. These eyelets allow urine to enter the tube and be drained from the bladder. A piece of PVC connector tubing (drain funnel) is attached to the opposite end of the PVC tube.

The provided text is a 510(k) summary for a urological catheter (Self Cath® Catheter) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Self Cath Plus). It does not contain information about acceptance criteria or specific studies detailing device performance against such criteria in the manner requested.

Therefore, I cannot provide a detailed answer to your request. The document describes the device, its intended use, and states that substantial equivalence is supported by a comparison of design, materials, and intended use, as well as "acceptable results from functional performance and biocompatibility testing." However, it does not specify what these "acceptable results" are, what acceptance criteria were used, or the details of the studies conducted. It also lacks information on sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Coloplast VIRTUE Ventral Urethral Elevation 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 provided text is a 510(k) summary for the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System. The available information primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as a such a study (with specific performance metrics, ground truth, and reader studies) appears not to have been conducted or detailed in this 510(k) summary. The submission relies on comparative analysis and bench testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give details on the number of samples or specific test cases.
• Data Provenance: Not specified. Given it's bench testing, it would likely be laboratory-generated data rather than patient data.

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

• This information is not available in the provided document. The study described is bench testing and comparative analysis, not a clinical study involving experts establishing ground truth for performance metrics in a patient context.

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

• This information is not applicable and not available. Adjudication methods are typically used in clinical studies or reader studies where multiple experts assess cases. The described testing is bench testing.

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, an MRMC comparative effectiveness study was not done. The device is a surgical sling system, not an AI or diagnostic imaging device.

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

• Not applicable. The device is a physical surgical implant, not an algorithm.

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

• For the bench testing, the "ground truth" would be objective measurements of physical properties (e.g., tensile strength, elasticity, pore size) and material properties that are compared against predefined specifications or the predicate device's characteristics. The document implies comparison to the predicate device's known characteristics as the "truth" for equivalence.

8. The sample size for the training set

• Not applicable / Not available. The device is a physical product, not an AI algorithm that requires a training set. The "testing" involved bench testing, not machine learning model training.

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

• Not applicable / Not available. (See point 8).

In summary: The 510(k) summary focuses on demonstrating "substantial equivalence" of the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System to a legally marketed predicate device (AMS AdVance Male Sling System) through a comparison of design, materials, performance characteristics (via bench testing), and indications for use. It does not contain details of a clinical study with quantifiable acceptance criteria for diagnostic accuracy, reader performance, or patient outcomes that would typically involve experts, ground truth, or specific sample sizes in the manner implied by the questions.

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Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.

The Coloplast Self-Cath® CS Closed System catheter (also referred to as "SCCS") is an extension of the existing Coloplast Self-Cath product line. The device is a modification of the Coloplast (Mentor) Self-Cath Closed System catheter, which was cleared under 510(k) K003873. It is available singly and as part of a kit.

The SCCS is intended to be used to drain urine from the bladder. The SCCS is a catheter and collection bag assembly for inserting a catheter from a closed, sterile bag through an insertion tip into the bladder. It consists of a sterile, pre-lubricated catheter with a pre-lubricated introducer tip on the proximal end, which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter and introducer tip are pre-lubricated with a water-soluble hydrophilic water-based lubricant. The catheter provides a conduit for draining the bladder into the pre-attached urine collection bag.

This document is a 510(k) summary for the Coloplast Self-Cath® CS Closed Urinary Catheterization System, seeking clearance due to substantial equivalence to a previously cleared device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for diagnostic AI/ML products.

This 510(k) is for a physical medical device (a catheter system), not a software or AI-driven diagnostic device. Therefore, the questions about performance metrics (e.g., sensitivity, specificity), ground truth, expert readers, and training/test sets are largely incongruent with the information provided. The "acceptance criteria" for a device of this type would typically revolve around physical and biological compatibility, manufacturing quality, and functional performance relative to its predicate, rather than algorithmic accuracy.

However, I will extract relevant information and address the questions to the best of my ability based on the provided text, highlighting where the information is not applicable or available for this type of device submission.

Acceptance Criteria and Study Information for the Self-Cath® CS Closed Urinary Catheterization System

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

For this type of physical medical device, acceptance criteria are generally established against the functional, material, and safety characteristics of a legally marketed predicate device. The document states a claim of "Substantial Equivalence," which is the primary "acceptance criterion" for a 510(k) submission. Performance is assessed by demonstrating this equivalence through various tests (often mechanical, biological, and material compatibility), which are not detailed in this summary.

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 in the 510(k) summary. For a physical medical device, "test set" would typically refer to the samples used in engineering, biocompatibility, and sterility testing, not clinical data sets in the way AI/ML products require. The document states it is a "modification" of an existing device (K003873), implying that much of the foundational testing and validation was done for the predicate, and this submission focuses on demonstrating that the modifications do not alter the substantial equivalence.

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 information is not applicable/provided. For a physical catheter system, "ground truth" and expert consensus in the diagnostic sense are not relevant. Clinical performance might be assessed via user feedback or clinical studies (which are not detailed here), but this is different from establishing ground truth for AI/ML evaluation.

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

This information is not applicable/provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not a part of the substantial equivalence process for a physical device like a catheter.

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 information is not applicable/provided. MRMC studies are used to evaluate the performance of diagnostic imaging devices, often involving AI. This device is a catheter, not a diagnostic imaging or AI device, so such a study would not be performed.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

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

This information is not applicable/provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this physical device. The "truth" for a catheter would be its ability to correctly drain urine, its sterility, material safety, and physical properties, which are assessed through engineering and biological testing.

8. The sample size for the training set

This information is not applicable/provided. The concept of a "training set" is for AI/ML models. This document describes a physical medical device.

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

This information is not applicable/provided. Similar to point 8, this question is not relevant for the device described in the document.

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