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The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infaccerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use:

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

The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

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

ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity.

The catheters are supplied sterile for single-use only.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet for approval. Instead, it presents the results of a randomized controlled trial and uses this data to inform a warning to be included in the device labeling. The performance is reported in terms of mortality rates for different patient cohorts.

Note: The p-value is from Fischer's exact test.

The conclusion drawn from this study is that "The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury." This indicates that for these specific conditions, the observed mortality rates were either higher in the Cool Line group or not statistically different enough to confirm safety, leading to a labeling warning rather than a clear "acceptance" for those indications. The device is indicated for fever reduction in adult patients with cerebral infarction and intracerebral hemorrhage, implying that its performance for these conditions was considered acceptable despite the lack of explicit "acceptance criteria" in this document.

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

• Sample Size (Test Set): 296 patients.
• Data Provenance: The document states "a randomized controlled trial." While the country of origin is not explicitly mentioned, FDA review documents typically pertain to devices intended for the US market, and the listed address for ZOLL Circulation, Inc. is Sunnyvale, California, USA. The trial type is prospective as it's a randomized controlled trial.

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

The document describes a randomized controlled clinical trial measuring mortality. No information is provided about experts establishing a "ground truth" for the test set in the context of diagnostic performance. The "ground truth" in this context is the actual clinical outcome (mortality), which is a direct observation.

4. Adjudication Method for the Test Set

No information is provided about an adjudication method. The trial measured mortality, which is a definitive outcome and typically doesn't require adjudication in the way diagnostic interpretations might.

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

This document describes a clinical trial for a thermal regulating catheter, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was done and the concept of "human readers improve with AI" is not applicable.

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

Again, this is a physical medical device (catheter) for thermal regulation, not an algorithm or AI. Therefore, no standalone performance study was done in the context of an algorithm.

7. The Type of Ground Truth Used

The ground truth used in the clinical trial was outcomes data, specifically mortality by diagnosis.

8. The Sample Size for the Training Set

No information is provided about a "training set." The study described is a clinical trial, which typically has a single patient cohort (divided into treatment and control groups) rather than separate training and test sets in the machine learning sense.

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

Not applicable, as there is no "training set" described in the context of this device and study. The ground truth (mortality) for the clinical trial was established through direct observation of patient outcomes.

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The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, 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 ICY™ catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient.

Additional lumens of the Alsius Icy™ Catheter Model IC-3893A consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.

The Icy™ Catheter Model IC-3893A is the same as the predicate device, the Icy™ Model IC-3585A except that it has two extra infusion lumens with a corresponding increase in shaft diameter. The heat exchange capability of the two catheters is the same.

The provided document is a 510(k) summary for a medical device called the Icy™ Catheter Model IC-3893A. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific, pre-defined acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI/ML-based device. The original content describes a comparison to a predicate device for regulatory approval, focusing on technical characteristics and intended use.

However, I can extract the information that is present and explain why the other requested details are not available.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported device performance in the context of an AI/ML device study. Instead, it compares the technical characteristics of the new device (Icy™ IC-3893A) to a predicate device (Icy™ IC-3585A) to demonstrate substantial equivalence.

Acceptance Criteria for Substantial Equivalence (implied by the 510(k) process): The device's characteristics do not raise new questions of safety and effectiveness compared to the predicate device. Performance data (not detailed in this summary) demonstrate equivalence where appropriate.

Reported Device Performance: The document states that the heat exchange capability of the two catheters is the same. The overall conclusion is that descriptive information and performance data (which are not extensively detailed in the summary but would have been part of the full 510(k) submission) demonstrate that the new catheter characteristics do not raise new questions of safety and effectiveness, and where appropriate, performance data demonstrate equivalence.

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

• Not applicable. This document is a 510(k) summary for a physical medical device (catheter) based on substantial equivalence, not an AI/ML study with a test set. There is no mention of a "test set" in the context of data 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. See point 2.

4. Adjudication method for the test set

• Not applicable. See point 2.

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 is for a physical medical device and does not involve AI or human readers in the context of an MRMC study.

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

• Not applicable. See point 5.

7. The type of ground truth used

• Not applicable. As this is a physical device submission focused on substantial equivalence to a predicate, "ground truth" in the AI/ML sense is not relevant. The "truth" for this submission is based on the established safety and effectiveness of the predicate device and the physical and functional characteristics of the new device.

8. The sample size for the training set

• Not applicable. See point 2.

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

• Not applicable. See point 2.

In summary: The provided document is a regulatory submission (510(k) summary) for a conventional medical device (catheter) seeking market clearance based on substantial equivalence to a previously cleared predicate device. It focuses on comparing technical characteristics and intended use. The questions posed are highly specific to AI/ML device studies, which are not described or implied in this document.

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