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The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use:

· In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care.

(Maximum use period: 4 days)

· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)

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 hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard 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 recovery/intensive care.

The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

The provided text is a 510(k) summary for a medical device (intravascular heat exchange catheters and associated consoles). It describes the device, its intended use, a comparison to predicate devices, and nonclinical testing that was performed. However, it explicitly states that clinical evaluations were NOT performed for this change (see section V. SUMMARY OF CLINICAL TESTS PERFORMED on page 18).

Therefore, it is not possible to extract the requested information regarding acceptance criteria and studies that prove the device meets these criteria, as the submission focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, rather than a de novo clinical study with specific performance acceptance criteria.

The clinical trial information presented in the document (the table with CI, ICH, PTBI, SAH patient cohorts, and mortality percentages) is not a study performed to prove the acceptance criteria of this specific device, but rather a reference to a randomized controlled trial that influenced the FDA's decision to add a "Warning - Fever Reduction" limitation to the device's labeling. This trial evaluated the safety and effectiveness of the Cool Line Intravascular Heat Exchange Catheter generally, and its results (increased mortality in certain cohorts compared to standard of care) led to the specific warning about its use for fever reduction in patients with subarachnoid hemorrhage or primary traumatic brain injury. It does not represent a study designed to meet pre-defined acceptance criteria for the device in this 510(k) submission.

Given this, I cannot fill the table or answer the specific questions about "proving the device meets acceptance criteria" as no such study is presented in the provided document for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and nonclinical testing for "MR Conditional" labeling.

If you had a document describing a clinical study undertaken specifically to demonstrate the performance characteristics of this device against defined acceptance criteria, I would be able to provide the requested information.

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The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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® 3000 and Cool Line™ Catheter Thermal Regulation 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 and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The provided document is a 510(k) Summary and an FDA 510(k) clearance letter for the Alsius CoolGard 3000 and Catheter Thermal Regulation System. This submission is for modifications to the software of an existing device, and the device acts as its own predicate.

As such, acceptance criteria and device performance in the traditional sense of a new medical device showing clinical efficacy or diagnostic accuracy are not explicitly outlined as a pass/fail threshold. Instead, the study aims to demonstrate that the software modifications do not raise new questions of safety or effectiveness and that the updated system is substantially equivalent to its existing predicate (itself).

The document details a randomized controlled trial that was previously conducted, which is relevant to a specific warning for the device, rather than being the primary study proving the current software modification meets acceptance criteria.

Let's break down the information based on your request, focusing on what is available and noting where details are not provided due to the nature of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a software modification to an existing device, the "acceptance criteria" are not reported as specific performance metrics against a threshold for new clinical efficacy. Instead, the acceptance criteria are implicitly that the software modifications do not negatively impact the device's safety or effectiveness as established by its previous clearances. The reported device performance relates to a clinical trial mentioned in a warning on its labeling.

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

The primary "test set" discussed in relation to clinical outcomes is from a randomized controlled trial of 296 patients. This study's data informs a warning related to fever reduction with the Cool Line Catheter.

• Sample Size (for the referenced clinical trial): 296 patients
  • Cool Line group: (16 CI + 33 ICH + 44 PTBI + 61 SAH) = 154 patients
  • Control group: (14 CI + 27 ICH + 38 PTBI + 63 SAH) = 142 patients
• Data Provenance: The document does not specify the country of origin. It is a retrospective analysis of previously collected data, forming the basis of a clinical trial used to establish a warning rather than being a prospective trial for the current software modification. The trial itself would have been prospective to collect the data, but the analysis presented here is of already completed data.

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

This information is not provided in the document. The clinical trial generated patient outcomes (mortality), which served as the "ground truth" for evaluating the safety concern, rather than requiring expert consensus on a subjective measure.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the outcome measured was mortality, which is an objective endpoint, a formal adjudication method for interpretation might not have been
explicitly required in the same way it would be for subjective diagnostic evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. The device in question is a thermal regulation system, not an imaging or diagnostic AI device. The study cited is a randomized controlled trial assessing mortality outcomes.

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

No, a standalone algorithm-only study was not done in the context of diagnostic performance. The device is a physical thermal regulation system with software control. The "algorithm" here refers to the software controlling the device's function. The 510(k) submission for the software modification indicates that software revisions were made and "supportive evidence is provided to establish that there are no new questions of safety or efficacy." The details of this "supportive evidence" are not fully elaborated in the summary but would likely involve verification and validation testing of the software changes to ensure it performs as intended and does not introduce hazards (e.g., in a standalone testing environment for the software, but not in the sense of a standalone clinical performance study).

7. The Type of Ground Truth Used (for the described clinical trial)

The ground truth for the clinical trial was outcomes data, specifically mortality. Mortality is an objective and directly observable outcome.

8. The Sample Size for the Training Set

The document is for a 510(k) submission for a software modification to an existing medical device. It does not describe a machine learning algorithm or an AI model that would require a "training set" in the conventional sense. The "software revisions" mentioned would have been developed and tested, but the term "training set" doesn't apply here.

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

As noted above, there is no "training set" in the context of this 510(k) submission. The software modifications would have undergone software validation and verification according to established engineering and regulatory practices, rather than being "trained" on data.

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The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the Icy™ 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.

"he CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes.

Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users.

Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:

• 1. ICY™ Catheter Kit Model IC-3585A
• 2. Fortius™ Catheter Kit Model FR-5093A

The ICY™ and Fortius™ catheters are multi lumen intravascular catheters in various sizes. Two of the catheter's lumens 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 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 Catheters consist of a standard guide wire lumen that can be used as a primary infusion lumen, and a second infusion lumen within the shaft, depending on the catheter model selected by the clinician.

The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation.

The Alsius Catheters are supplied sterile for single-use only.

Principles of Operation:

The CoolGard™ 3000 system automatically adjusts the temperature of the heater/chiller saline bath to achieve the patient target temperature that has previously een set by the attending physician. This is done via data from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to currently marketed devices.

The provided 510(k) summary for the Alsius CoolGard and Catheter Thermal Regulation System states that performance data demonstrate equivalence to the predicate device, but it does not specify detailed acceptance criteria or present a study proving the device met those criteria. The 510(k) summary focuses on demonstrating substantial equivalence based on identical indications for use, principle of operation, and similar technical characteristics and materials compared to the predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on equivalence to predicate devices rather than a new set of performance metrics.
• Sample size used for the test set and the data provenance: No specific test set or associated data is described for performance evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment is detailed.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a thermal regulation system, not an AI-assisted diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Basis for Substantial Equivalence (as described in the document):

The 510(k) submission's core argument for substantial equivalence is based on the following:

• Identical Indications for Use: The CoolGard and Catheter Thermal Regulation System's indications for use are identical to the predicate device.
• Identical Principle of Operation: The principle of operation, which involves automatically adjusting saline bath temperature based on a patient temperature probe to achieve a set target temperature, is identical to currently marketed devices (including the predicate).
• Similar Technical Characteristics and Materials: The technical characteristics of the catheter (biocompatible polyurethanes, heat exchange balloons, multiple lumens, heparin coating) and the CoolGard™ 3000 heater/cooler (integrated electro-mechanical heater/cooler, temperature monitor/controller, heat exchanger, roller pump, redundant safety controls, alarms, patient monitoring, temperature displays) are described as "very similar" or "essentially identical" to the predicate devices.

Conclusion stated by the submitter:

"In summary, descriptive information and performance data demonstrate that the Alsius CoolGard and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The CoolGard and Catheter Thermal Regulation System is substantially equivalent to the predicate device."

In essence, the "study" demonstrating the device meets "acceptance criteria" is the comprehensive comparison of its design, function, and intended use against already legally marketed predicate devices, concluding that there are no new questions of safety or effectiveness. Specific quantitative performance metrics or studies beyond this comparative analysis are not detailed in the provided summary.

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The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Regulation 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 and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes.

Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users.

Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:

1. Cool Line™ Catheter Kit Model CL 2085B (2 lumens)
2. Cool Line™ Catheter Kit Model CL 2295A (3 lumens)

The Cool Line™ catheters are multi lumen intravascular catheters in two sizes. Two of the catheter's lumens 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 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 Catheters consist of a standard quide wire lumen that can be used as a primary infusion lumen, and a second or third infusion lumen within the shaft, depending on the catheter model selected by the clinician.

The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation.

The Alsius Catheters are supplied sterile for single-use only.

The provided document is a 510(k) summary for a medical device called the "Alsius CoolGard™ and Cool Line™ Catheter Thermal Regulation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the results of a clinical trial related to its safety and effectiveness for fever reduction.

It does not contain information about specific "acceptance criteria" for the device's performance in a diagnostic or classification sense, nor does it describe a study designed to prove the device meets such criteria.

The document describes the results of a randomized controlled clinical trial, but this trial assesses the safety and effectiveness of the device in a clinical context (mortality rates in different patient cohorts) rather than validating specific technical performance criteria of an AI or diagnostic algorithm.

Therefore, I cannot fulfill most of your request directly from the provided text, as the information isn't present.

However, I can extract information related to the clinical trial that was conducted:

1. A table of acceptance criteria and the reported device performance

(Not Applicable): The document does not define specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI or device. Instead, it presents mortality rates from a clinical trial to demonstrate safety and effectiveness for its intended use.

Here's the clinical trial data on mortality:

Note: CI = cerebral infarction, ICH = intracerebral hemorrhage, PTBI = primary traumatic brain injury, SAH = subarachnoid hemorrhage. The device is indicated for CI and ICH, and the warning explicitly states safety has not been demonstrated for PTBI or SAH.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The clinical study was a randomized controlled trial of 296 patients.
The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond "randomized controlled trial". Randomized controlled trials are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

(Not Applicable): This was a clinical trial assessing device safety and effectiveness (mortality rates) in patients, not a study establishing ground truth for a diagnostic algorithm based on expert review. The "ground truth" here is the clinical outcome (mortality) observed in patients.

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

(Not Applicable): As above, this was a clinical trial evaluating patient outcomes, not a diagnostic accuracy study requiring adjudication of expert interpretations.

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 for a thermal regulation system, not an AI or diagnostic imaging device that involves human readers interpreting cases.

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

(Not Applicable): This is a medical device (catheter and thermal regulation system), not a standalone algorithm.

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

The "ground truth" in this clinical trial was outcomes data, specifically mortality in the enrolled patient cohorts.

8. The sample size for the training set

(Not Applicable): This document describes a clinical trial for a medical device, not the development or training of an AI algorithm. There is no mention of a "training set" in the context of an algorithm.

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

(Not Applicable): As above, this is not an AI algorithm development study.

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