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The Solex Catheter Model SL2593, connected to an Alsius External 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 SOLEX catheter is a multi lumen intravascular catheter. The catheter has 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 12.2 mm 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 Solex Catheter Model SL2593 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 provided document is a 510(k) summary for the Alsius Solex Catheter Model SL2593, which is a submission to the FDA for market clearance based on substantial equivalence to a predicate device. This type of submission generally does not include a detailed study proving the device meets acceptance criteria in the same way a clinical trial for a novel drug or a high-risk device might. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable in this context, as this document is not a report of a new clinical study with acceptance criteria being met in a statistically powered trial.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of "acceptance criteria" with measured performance for the Solex Catheter in the way it would for a clinical trial endpoint. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Alsius Fortius Catheter Kit Model FR-5093, K030421) by comparing technical characteristics and intended use.

The "performance" is implicitly considered equivalent if the technical changes do not raise new questions of safety and effectiveness, and the basic operating principle and indications for use are the same.

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

• Sample Size for Test Set: Not applicable. This is not a study with a test set in the conventional sense. The submission relies on comparative analysis with a predicate device.
• Data Provenance: Not applicable. The data primarily consists of engineering and design specifications for the new device and a comparison to the predicate device.

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

• Number of Experts: Not applicable. Ground truth as typically established by medical experts for clinical endpoints is not part of this 510(k) submission for substantial equivalence based on technical comparison.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There was no test set requiring expert adjudication.

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:

• MRMC Study: Not applicable. This device is a catheter for thermal regulation, not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This device is a physical medical device (catheter) and associated system, not an algorithm. Its operation involves human medical professionals.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the predicate device. The new device is compared against the predicate's characteristics and performance to demonstrate that it is "substantially equivalent." There isn't a separate, independently established ground truth for the new device's performance in a clinical setting presented in this document.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is a medical device submission, not an AI/machine learning model submission that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

• How Ground Truth for Training Set was Established: Not applicable. This is a medical device submission, not an AI/machine learning model submission.

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The THERMOGARD XP can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use.

The THERMOGARD XP/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.

The Alsius THERMOGARD XP™ 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 THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller primo. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

The technical characteristics of the Catheter are identical to the predicate device.

The Alsius THERMOGARD XP and Catheter Thermal Regulation System is indicated for fever reduction in patients with cerebral infarction and intracerebral hemorrhage who require central venous access, intubation, and sedation. It is also indicated for use in cardiac surgery patients to achieve and 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.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): A total of 296 patients were enrolled in the randomized controlled trial for fever reduction. The breakdown per cohort is:
  • Cerebral Infarction (CI): 16 (Cool Line) + 14 (Control) = 30 patients
  • Intracerebral Hemorrhage (ICH): 33 (Cool Line) + 27 (Control) = 60 patients
  • Primary Traumatic Brain Injury (PTBI): 44 (Cool Line) + 38 (Control) = 82 patients
  • Subarachnoid Hemorrhage (SAH): 61 (Cool Line) + 63 (Control) = 124 patients
• Data Provenance: The text does not explicitly state the country of origin. The study was a "randomized controlled trial," indicating it was prospective in nature.

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

The provided text does not specify the number or qualifications of experts used to establish ground truth for morbidity/mortality outcomes in the randomized controlled trial. Mortality data appears to be objective (number of deaths).

4. Adjudication Method for the Test Set

The provided text does not specify any adjudication method for the test set outcomes. Given that the primary outcome described is mortality, it's typically an objective measure that may not require complex adjudication.

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 device is a thermal regulation system, not an AI-powered diagnostic or interpretive device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers (or "AI assistance") is not applicable to this product.

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

This device is a physical medical device (an integrated electro-mechanical heater/cooler and catheter system) that directly modifies patient temperature. It is operated by medical professionals. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this type of device. Its performance is intrinsically linked to its physical function in a patient setting under human supervision.

7. The Type of Ground Truth Used

For the fever reduction indication, the ground truth used was mortality data (i.e., patient outcomes).

8. The Sample Size for the Training Set

The document describes a randomized controlled trial for evaluating safety and effectiveness for fever reduction. In such a trial, the entire patient cohort (296 patients) generally serves as the "test set" to evaluate the device's performance against a control group. The concept of a separate "training set" is typically associated with machine learning or artificial intelligence models, which is not relevant here as this is a physical medical device. Therefore, there is no distinct training set as would be understood in an AI context. The study population is the performance evaluation set.

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

As explained in point 8, there isn't a separate "training set" in the context of this device and study design. The ground truth (mortality) for the study population was established by observing and recording patient outcomes (death) in both the device-treated group and the control group of the randomized controlled trial.

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The Quattro Catheter Model IC4593, connected to an 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 QUATTRO 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 provided 510(k) summary for the Alsius Quattro Catheter Model IC4593 does not contain information about acceptance criteria or a study proving the device meets said criteria as would be expected for an AI/ML powered device submission.

This document is for a medical device (a catheter) with physical characteristics and indications for use, not for a software or AI-driven diagnostic or treatment system. Therefore, the questions related to AI/ML device performance (like accuracy metrics, sample sizes for AI training/testing, expert adjudication, MRMC studies) are not applicable to this submission.

The document focuses on:

• Device identification: Name, common name, classification, predicate device.
• Intended use/Indications for Use: What the device is designed to do (achieve/maintain normothermia or induce/maintain/reverse mild hypothermia).
• Technical Characteristics: Description of the catheter's design (multi-lumen, saline circulation for heat exchange).

There is no mention of an algorithm, AI, machine learning, or any computational aspect that would require the establishment of ground truth or performance metrics like sensitivity, specificity, or AUC based on expert review.

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The THERMOGARD can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use.

The THERMOGARD/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.

The Alsius THERMOGARD™ 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 THERMOGARD and Catheter Thermal Regulation System consists of the THERMOGARD, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD and the intravascular Catheter. The THERMOGARD 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 identical to the predicate device with the exception of revisions to the software that controls the device.

All models of Alsius Intravascular catheters are available for use with the THERMOGARD.

The provided text describes a 510(k) summary for the ALSIUS CORPORATION'S THERMOGARD and Catheter Thermal Regulation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a study proving a device meets those criteria for a novel technology.

However, the document does contain information about a clinical trial related to the device's use in fever reduction and outlines certain limitations on its use based on the trial results. This information can be re-purposed to infer a type of "acceptance criteria" based on the observed safety and effectiveness, and the study details are provided.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in the typical sense for a new device's performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it presents mortality rates from a clinical trial that led to a warning and limitation on the device's indications for use.

The "acceptance criteria" here are effectively inferred limits on where the device's performance was considered safe and effective enough for its intended use, particularly for fever reduction, based on its performance relative to a control group. For the conditions where the device was not shown to be safe and effective, the mortality rates in the Cool Line group were not significantly better (and in some cases numerically worse) than the control group.

Note: The p-values indicate a lack of statistically significant difference between the Cool Line and Control groups in mortality for all cohorts in this specific trial. However, for PTBI and SAH, the Cool Line group numerically had higher mortality, which contributed to the FDA's warning about lack of demonstrated safety and effectiveness for those indications for fever reduction.

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

• Test Set Sample Size: A randomized controlled trial of 296 patients was conducted.
  • 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 explicitly state the country of origin. It is a prospective randomized controlled trial.

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

This type of information is generally not applicable to a clinical trial involving patient outcomes like mortality. The "ground truth" here is the actual patient outcome (mortality), which is a definitive clinical event, not an expert interpretation of an image or a condition. Therefore, no experts were "establishing ground truth" in that sense.

4. Adjudication Method for the Test Set

Not applicable in the context of a clinical trial where the primary endpoint is mortality. Mortality is typically recorded as a factual event, not subject to adjudication in the same way, for example, an imaging diagnosis or a pathological finding might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, this was not an MRMC study. An MRMC study typically involves multiple human readers interpreting cases (e.g., medical images) to assess diagnostic performance, often with and without AI assistance, and then analyzing the variability and agreement among readers. This study was a randomized controlled trial comparing a medical device with an active control group based on patient survival outcomes.
• Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this was not an imaging diagnostic study involving human readers and AI assistance.

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

• No, this was a study of a medical device (THERMOGARD Thermal Regulation System) used in patients, with human medical staff operating and managing the system. It is not an algorithm designed for diagnostic or predictive tasks that could operate "standalone" in the medical sense of an AI model only.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Outcomes Data: The ground truth was mortality, which is a definitive clinical outcome.

8. Sample Size for the Training Set

The document describes a clinical trial (a "test set" or pivotal study) evaluating the device in humans. It does not mention a "training set" in the context of machine learning or AI model development. The device itself is electro-mechanical, not an AI algorithm that would typically require a training set in that sense.

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

Not applicable, as there is no mention of a machine learning "training set" for an AI algorithm.

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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 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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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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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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