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The UC-CARE Warming System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.

The UCW System is indicated to transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate. The UCW System includes a Urethral Catheter & Tubing Set and a Warming Kt

The Urethral Catheter is introduced into the bladder to outline the urethral course, and to protect the urethra during therapeutic transperineal, prostatic cryotherapy procedures. The Urethral catheter further transfers heat to the urethral tissue during cryotherapy of the prostate in order to protect the urethra from, excessive cold temperatures. The closed loop Tubing Set is connected to the catheter's inlet and outlet ports and circulates warm sterile water or saline via the Warming Kit that includes a fluid warmer and peristaltic pump.

This 510(k) summary describes a medical device, the UC-CARE Warming System, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the way a clinical trial or performance study for an AI/ML device would. Instead, it focuses on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

Therefore, many of the requested fields related to AI/ML performance, ground truth, expert adjudication, and sample sizes for testing/training sets cannot be filled from the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a "substantial equivalence" claim based on a comparison to predicate devices and adherence to relevant standards. This is not a clinical study in the typical sense of measuring specific performance metrics against predefined thresholds. Instead, it's a demonstration that the new device shares fundamental characteristics with devices already cleared by the FDA.

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

• Not applicable. This document describes a medical device (warming system), not an AI/ML algorithm that predicts or classifies based on data. The "test set" in this context would refer to the physical device itself being tested for safety and functionality, not a dataset for an algorithm.

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

• Not applicable. Ground truth, in the context of expert consensus, is typically for evaluating the accuracy of an AI/ML algorithm against human expert judgment. This is a physical device.

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

• Not applicable. This refers to a method for resolving discrepancies among experts when establishing ground truth for an AI/ML algorithm's performance evaluation.

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 relates specifically to the performance of AI/ML systems in conjunction with human readers.

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

• Not applicable. This document describes a physical medical device, not an AI/ML algorithm that operates in a standalone capacity.

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

• Not applicable. This refers to the reference standard against which an AI/ML algorithm's performance is measured. For this physical device, "ground truth" would be the verified safety and functional performance of the device under various conditions, likely verified through engineering tests, biocompatibility tests, and comparison to predicate device specifications.

8. The sample size for the training set:

• Not applicable. This pertains to the data used to train an AI/ML algorithm.

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

• Not applicable. This pertains to the labeling or truth assignment of data used to train an AI/ML algorithm.

Summary of Device-Specific Information from the Provided Text:

• Device Name: UC-CARE Warming System (UCW System)
• Intended Use: To transfer heat to the urethral tissue during urological cryosurgical procedures of the prostate using cryosurgical systems that have been cleared for use on the prostate.
• Predicate Devices:
  • Endocare Urethral Warming System (K963970)
  • SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA (PresIce™) (K060390)
• Performance Standards: Tested according to various standards and guidance documents, specifically mentioning ASTM F623-99 (2006) - Standard Performance Specification for Foley Catheter.
• Conclusion: The manufacturer believes the device is substantially equivalent to its predicate devices without raising new safety or effectiveness concerns based on the provided information.

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