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The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder.

The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments. The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet. The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).

This document is a 510(k) Premarket Notification for a medical device (Wellead® PVC Hydrophilic Urethral Catheter), not a study report for an AI/ML-driven device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, training set details, or effect size of AI assistance on human readers.

The document discusses the substantial equivalence of the subject device to predicate devices based on bench testing and biocompatibility testing, rather than clinical performance studies involving AI or human interpretation of results.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria for AI/ML Performance: The acceptance criteria listed in the document (ASTM, ISO standards for physical properties, biocompatibility) are for a physical medical device (catheter), not a software or AI/ML device that requires performance metrics like sensitivity, specificity, or AUC.
• Study Design for AI/ML Performance: The "Test Summary" section outlines laboratory bench tests and biological evaluations for the catheter, not diagnostic performance studies like those typically conducted for AI/ML algorithms.
• AI/ML Specifics (Sample Size, Ground Truth, Experts, MRMC): These concepts are entirely absent because the device is a physical catheter, not an AI/ML algorithm. There are no "test sets" of data for an AI to analyze, no "ground truth" to establish for an AI, and no "human readers" whose performance is assisted by AI.

In summary, this document is for a traditional medical device clearance, not an AI/ML device, and thus does not contain the type of information you've requested.

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The PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The PVC Hydrophilic Urethral Catheter is a single use urinary catheter designed for clean intermittent catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer with/without water sachet (pure water). The catheters are coated with a coating containing polyvinyl pyrrolidone (PVP) - a kind of hydrophilic polymer, which binds the water molecules to the catheter to reduce the risk of friction while inserting the catheter into the urethra. Coating is activated by the water by squeezing the water sachet or purified water. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.

This document describes a 510(k) premarket notification for a PVC Hydrophilic Urethral Catheter (K212567). However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical urological catheter, not an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of medical device described in the provided text.

The document primarily focuses on demonstrating "substantial equivalence" of the new PVC Hydrophilic Urethral Catheter to a legally marketed predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) based on non-clinical performance testing and biocompatibility testing.

Here's a breakdown of the information that is present, but tailored to a physical medical device, not an AI/ML one:

Acceptance Criteria and Device Performance (for a physical catheter)

The document states that the "PVC Hydrophilic Urethral Catheter meets all the pre-determined testing and acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria. It mentions the types of tests conducted:

Explanation of the Study and its intent:

The study conducted was a non-clinical performance testing and biocompatibility testing program. The purpose of these tests was to demonstrate that the new PVC Hydrophilic Urethral Catheter is substantially equivalent to a predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) in terms of safety and effectiveness, as required for a 510(k) submission.

Regarding the specific questions asked for AI/ML devices, here's why they are not applicable and thus not available in the provided text:

1. Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML model. Testing was likely performed on
   physical catheter samples in a laboratory setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI/ML sense is established by human experts for a physical catheter's performance. Performance is measured against engineering specifications and biocompatibility standards.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for AI/ML model output, not physical device testing.
4. 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 for AI-assisted image interpretation or similar.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "truth" for this device's performance is derived from physical measurements (e.g., flow rate, strength, friction) and standardized biological responses from biocompatibility tests.
7. The sample size for the training set: Not applicable. No AI/ML model, so no training set.
8. How the ground truth for the training set was established: Not applicable. No AI/ML model, so no training set or ground truth establishment in that context.

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The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The Well Lead PVC Hydrophilic Urethral Catheter is a flexible tubular single use urinary catheter that is inserted through the urethra to allow drainage of the bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds it becomes slippery and ready to use.
The catheters come in sizes from 12Fr-24Fr for Male, 12Fr-24Fr for Female and 6Fr-10Fr for Pediatric.

The provided text describes the regulatory submission for the Well Lead PVC Hydrophilic Urethral Catheter. However, it does not contain information about a study comparing the device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop system. The document is primarily a 510(k) summary demonstrating substantial equivalence to a predicate device for a medical catheter, focusing on non-clinical performance and biocompatibility.

Therefore, many of the requested categories related to AI models, clinical studies, ground truth establishment, and expert involvement are not applicable to the provided information.

Here's an analysis based on the information available:

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

The document lists performance tests with the standard they were tested to and the result ("Complies"). These can be considered the acceptance criteria for those specific physical and material properties.

*Note: For sterility, ETO residual, and biocompatibility, the document states the validation method or that the tests were performed, which implies the results met the criteria for approval, even if the exact "Complies" is not explicitly stated in the table for every test as it is for others.

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

For the non-clinical performance testing (Flow Rate, Strength, Connector Security, Coefficients of Friction), testing was completed on 3 different size catheters: 8Fr (pediatric size), 14Fr, and 24Fr. The document doesn't specify the number of units per size.
For other tests like packaging and biocompatibility, the sample size is not explicitly stated.
The data provenance (country of origin, retrospective/prospective) is not mentioned for these tests. This is a medical device submission, not a clinical trial or AI study, so standard data provenance details for patient data are 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. This document is about the physical and chemical properties of a medical device, not an AI model requiring expert-established ground truth from images or patient data.

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

Not applicable. This is not an AI model evaluation study involving human adjudication of results.

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 document does not describe an AI device or an MRMC study.

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

Not applicable. This document does not describe an AI algorithm.

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

For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 11607, EN1616) they were tested against. The physical and chemical properties of the catheter (e.g., flow rate, strength, seal integrity, biocompatibility) are measured against these established engineering and biological safety standards.

8. The sample size for the training set

Not applicable. This document does not describe an AI model with a training set.

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

Not applicable. This document does not describe an AI model.

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