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For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement. The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.

The provided text describes a 510(k) premarket notification for a Urological Catheter, focusing on its substantial equivalence to predicate devices. The information primarily covers device description, intended use, technological characteristics, and non-clinical performance data. It does not contain the specific details required to complete your request for acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance, human readers, or detailed test set characteristics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/algorithm-based device, as this documentation pertains to a physical medical device.

The document discusses non-clinical performance data which includes:

• Design Qualification:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
  • Lubricity testing according to modified ASTM D1894.
• Long Term Stability/Shelf Life:
  • Included dimensional analysis, appearance, and functional testing according to EN 1616.
• Biocompatibility:
  • ISO 10993-5, Cytotoxicity
  • ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts
  • ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts

However, these are performance metrics for a physical device, not an AI or algorithm.

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