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The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the lcy™ or Fortius™ model catheter, is indicated for use:

• . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and
• . to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The Alsius CoolGard And Catheter Thermal Regulation System.

The provided text describes a 510(k) summary for the Alsius CoolGard and Catheter Thermal Regulation System, including an update to its labeling and a summary of a clinical trial used to evaluate the device. However, the document does not specify clear "acceptance criteria" for the device's performance in the typical sense of a pre-defined threshold that the device's metrics must meet to be considered effective or safe.

Instead, the document focuses on presenting the results of a randomized controlled trial and highlighting that the device's safety for fever reduction in certain patient populations (subarachnoid hemorrhage or primary traumatic brain injury) "has not been demonstrated." The mortality data is presented, but no explicit acceptance criteria or target performance values are given. The purpose of this submission appears to be related to demonstrating substantial equivalence for an MRI environment labeling change and providing information from a clinical trial, rather than proving the device meets specific pre-defined performance metrics for its primary indications.

Therefore, many of the requested elements regarding acceptance criteria and details of studies proving they were met cannot be fully extracted directly from this document.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly defined in the provided document. The 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices and presenting clinical trial data for risk assessment and labeling. There are no pre-specified quantitative performance thresholds (e.g., "mortality rate must be below X%" or "temperature reduction must be Y degrees") presented as acceptance criteria the device needed to meet.

Reported Device Performance (Mortality by Diagnosis from the Randomized Controlled Trial):

Note: The document states, "The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury." This implies that while the data is presented, it does not meet an implicit safety criterion for these patient groups, even though an explicit quantitative one isn't stated.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): The randomized controlled trial involved 296 patients in total.
  • Cool Line arm: 16 + 33 + 44 + 61 = 154 patients
  • Control arm: 14 + 27 + 38 + 63 = 142 patients
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "randomized controlled trial," which is prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a clinical trial involving patient outcomes (mortality), not a study requiring expert labeling or adjudication of images/data for ground truth. Patient mortality is an objective outcome.

4. Adjudication Method for the Test Set

Not applicable. As described above, the outcome measured was mortality, which is an objective clinical endpoint, not something that typically requires adjudication in the context of expert consensus or labeling.

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 document describes a clinical trial evaluating a thermal regulation system, not an AI-assisted diagnostic or interpretative device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This document describes a medical device (thermal regulation system) and its clinical performance. It does not refer to an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used was patient mortality data (an objective clinical outcome) in a randomized controlled trial.

8. The Sample Size for the Training Set

Not applicable. This document does not mention an algorithm or AI model that would require a training set. The clinical trial described pertains to the direct performance of the device on patients.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set for an algorithm is mentioned.

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