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Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The B. Braun Actreen® Hi-Lite Intermittent Urinary Catheters include the Actreen® Hi-Lite Cath and Actreen® Hi-Lite Set. The Actreen® Hi-Lite Set is identical to the Actreen® Hi-Lite Cath, except that the Actreen® Hi-Lite Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. The Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 14.5 inch length, a variety of gauge sizes and straight or curved tip configurations to accommodate the individual anatomy of both male and female users. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

This document is a 510(k) submission for a medical device called "Actreen® Hi-Lite Intermittent Urinary Catheters". It's a regulatory document seeking FDA approval, not a scientific study report with detailed acceptance criteria and performance metrics for a diagnostic or AI device. Therefore, the requested information elements related to AI models, ground truth, expert consensus, sample sizes for training/test sets, MRMC studies, and associated effect sizes are not applicable here.

However, I can extract the relevant information regarding performance testing that was conducted to support the substantial equivalence claim for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that performance testing was performed according to EN 1616: 1997 - Sterile Urethral Catheters for Single Use. The acceptance criteria would be defined within this standard. The document does not explicitly list specific numerical acceptance criteria or detailed performance results beyond stating that the testing was performed and supports substantial equivalence.

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

This document is for a physical medical device (urinary catheter), not a software or AI diagnostic. Therefore, there isn't a "test set" in the context of data used for algorithm validation. The "testing" refers to physical and biological evaluations of the catheter's materials and functionality according to established standards.

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not applicable in the context of image data or clinical patient data. The testing is for the manufactured device itself.

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

This is not applicable as there is no "ground truth" derived from expert interpretation in the context of a physical catheter's performance testing for regulatory approval.

4. Adjudication method for the test set:

Not applicable. There's no interpretive test set requiring adjudication.

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 a physical medical device, not an AI-powered diagnostic system.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

Not applicable in the AI/diagnostic sense. The "ground truth" for a physical device's performance is determined by adherence to established engineering and biocompatibility standards (e.g., material strength, sterility, non-toxicity, fluid flow rates if measured).

8. The sample size for the training set:

Not applicable. There is no training set for a catheter.

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

Not applicable. There is no training set for a catheter.

Summary of what the document does provide regarding the device and its testing:

• Device: Actreen® Hi-Lite Intermittent Urinary Catheters
• Purpose of Testing: To demonstrate substantial equivalence to a predicate device (Actreen® Mini Intermittent Urinary Catheters, K151772) for FDA 510(k) clearance.
• Types of Testing Performed:
  • Biocompatibility Testing: Performed in accordance with ISO 10993-1. The classification was for surface-contacting devices on mucosal membranes, with prolonged exposure (greater than 24 hours but less than 30 days).
  • Performance Testing: Performed according to EN 1616: 1997 - Sterile Urethral Catheters for Single Use.
• Conclusion: Based on the results of biocompatibility and performance testing, the proposed device is considered substantially equivalent to the predicate devices.

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