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This device is intended for providing drainage of urine from the urinary tract.

The Radiance™ Clear Sharklet® Silicone Foley is identified as a balloon retention type catheter and is supplied sterile for single-use. It is a two-way silicone Foley catheter manufactured in 14.0. 16.0 and 18.0 French sizes with an effective working length of 34 centimeters. One lumen is used for drainage and the other lumen for inflation and deflation of the balloon. Sterile media is used to inflate and deflate the balloon. The proximal end of the drainage lumen has a funnel for connection to a drainage collection device. The proximal end of the inflation lumen has a check valve for connection to a syringe for inflation. The distal end has two drainage eyes placed opposite each other which allow drainage. The shaft has the Sharklet® micro-pattern molded into the outer surface.

This document is a 510(k) Premarket Notification from the FDA regarding the Radiance™ Clear Sharklet® Silicone Foley Catheter. As such, it outlines the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device, rather than providing details of an AI/ML-based device and its performance study using a test set against acceptance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment for an AI/ML device is not present in the provided text.

The document focuses on:

• Device Identification: Radiance™ Clear Sharklet® Silicone Foley Catheter.
• Intended Use: Providing drainage of urine from the urinary tract.
• Predicate Device: Well Lead Silicone and Latex Foley Catheters (K082815).
• Performance Testing: Physical and mechanical testing to demonstrate compliance with ASTM F623-99 and additional specific testing related to the "Sharklet" micropattern. This includes:
  • Flow Rate through Drainage Lumen
  • Balloon Integrity
  • Inflated Balloon Response to Traction
  • Balloon Volume Maintenance
  • Dimensional Verification
  • Balloon Deflation Reliability
  • Friction Testing (comparing the Sharklet catheter to a control)
  • Ovine Study (animal study comparing the Sharklet catheter to a control in sheep for one month)
  • Accelerated aged performance testing
  • Biocompatibility
  • Sterility testing

No information is provided on:

1. Acceptance criteria and reported device performance (in the context of AI/ML metrics like sensitivity, specificity, etc.): The document describes engineering and biological performance tests, not AI model performance.
2. Sample sizes for a test set and data provenance: The ovine study involved "six sheep," but this is not a test set for an AI/ML model.
3. Number of experts and qualifications for ground truth: Not applicable for this type of device submission.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone (algorithm only) performance: Not applicable as it's a physical device.
7. Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable in the AI/ML sense.
8. Sample size for the training set: Not applicable as it's not an AI/ML model.
9. How ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes a 510(k) submission for a medical device (Foley catheter), not an AI/ML software as a medical device (SaMD). Therefore, the specific details requested for AI/ML device performance evaluation are not contained within the document.

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