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The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter.

The Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter is a sterile, single use, indwelling urinary drainage catheter extruded from 100% vulcanized silicone material, The catheter is coated with a lubricious hydrophilic topcoat containing an inozoa dinother releasing polymer.

The provided text describes a 510(k) premarket notification for the "Tyco Healthcare/Kendall DOVER® Silver Temperature Sensing Foley Catheter."

Based on the provided information, the device is a medical catheter and not an AI/ML powered device, therefore the information requested in points 1-9 regarding acceptance criteria and study details for AI/ML performance is not applicable.

The submission is for a medical device (urinary catheter with temperature sensing) that leverages substantial equivalence to existing devices rather than demonstrating novel AI/ML performance. The "Nonclinical Testing" section only mentions biocompatibility testing.

Here's a breakdown of what is available in the provided text:

• Device Type: Catheter, Retention Type, Balloon (specifically a Urinary Drainage Silicone Foley Catheter with Temperature Sensor)
• Purpose: Drainage/collection of urine and simultaneous monitoring of body core temperature.
• Approval Process: 510(k) A submission based on substantial equivalence to legally marketed predicate devices.
• Testing Mentioned: Biocompatibility testing, demonstrating compliance with ISO 10993 Standard, Part 1, and FDA modified matrix (memorandum G95-1).

Since this is a traditional medical device submission based on substantial equivalence and non-clinical biocompatibility testing, there is no information on:

1. A table of acceptance criteria and reported device performance (for AI/ML).
2. Sample size for test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

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