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When used with Thermogard XP® or Thermogard HQ™ console: Temperature reduction in patients 2 years and older where clinically indicated, e.g. in hyperthermic patients.

The Thermogard HQ™ Temperature Management System and Thermogard XP® Temperature Management System (herein referred as Thermogard Surface System) consists of a Thermogard Console (TGXP or TGHQ), a Surface Start-Up Kit (SSUK) and a Surface Pad whose function is to provide therapeutic cooling to a patient. The Thermogard Surface System including the VitalTemp™ Universal Pad as a surface pad, is designed to provide therapeutic cooling to patient's 2 years and older. The Surface System delivers treatment to the patient by recirculating cold fluid through a single-use surface pad (non-sterile) and its associated disposable tubing set, the Surface Start-Up Kit (SSUK). The fluid is the intermediate heat-transfer medium between the Thermogard Console and the surface pad.

The VitalTemp™ Universal Pad is a non-sterile disposable product. It is available in one size and can either be placed under, over the patient or used as a wrap. The VitalTemp™ is manufactured and processed using identical materials, internal parts, and processes as the Thermogard™ Vest, with the only difference being the size and shape of the surface pad.

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Thermogard HO™ Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

Thermogard XP® Temperature Management System Temperature reduction in adult patients where clinically indicated, e.g., in hyperthermic patients.

The subject of this 510(k) is the new surface feature which makes minor modifications to the existing IVTM Start-Up Kits (SUKs) to enable connection of a Thermogard console to the STx™ Vest provides for circulation of thermally conditioned fluid supplied by the Thermogard console (either Thermogard HQ™ or Thermogard XP®). Transfer of heat between the patient and the circulating fluid results in modification of patient core temperature for the purpose of therapeutic patient temperature modulation.

The existing, commercialized Thermogard Systems (Thermogard HQTM and Thermogard XP®) are used in conjunction with catheters placed in the vasculature to support intravascular cooling. The TGHQ-SURF accessory is a modification of the model TGHQ-500D accessory which was verified, validated, and commercialized. The CG-SURF accessory is a modification of the model CG-500D accessory which was verified, validated, and commercialized. These Surface SUK models are identical to their predecessors with the exception of longer inflow and outflow tubing lengths and replacing the Luers for catheters with 0.25inch hose barb valved connectors for the STx™ Vest. The Surface SUK also has a label on the fluid spike to indicate the size of bag of fluid (3000ml) to use and to mark it as non-sterile. The Surface SUKs are otherwise identical to their predecessors in terms of materials that contact the heat exchange fluid (i.e., saline), manufacturing process, and packaging materials.

There are no changes to the commercially available Thermogard XP® (K213031) and Thermogard HO™ (K220008) consoles.

There are no changes to the commercially available STxTM Vest.

The provided document is an FDA 510(k) summary for a medical device called the "Thermogard HQ™ Temperature Management System" and "Thermogard XP® Temperature Management System." These devices are thermal regulating systems used for temperature reduction in adult hyperthermic patients.

The document does not describe:

• Acceptance criteria for an AI/ML powered device. This device is a hardware system, not an AI/ML product.
• Performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML diagnostic tools.
• Any information regarding training sets, test sets, ground truth establishment by experts, or MRMC studies.

Therefore, the requested information cannot be extracted from this document, as it pertains to a different type of medical device lacking AI/ML components and the typical studies associated with them.

To directly answer your request based on the lack of relevant information in the provided text:

1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes a physical temperature management system, not a device with acceptance criteria based on AI/ML performance metrics like sensitivity or specificity. Performance testing mentioned is related to dimensional verification, functional testing, temperature behavior, shipping and handling, and electrical/EMC standards, not diagnostic accuracy.

2. Sample size used for the test set and the data provenance:
Not applicable. There is no mention of a "test set" in the context of an AI/ML algorithm's performance evaluation. The document refers to "performance testing" of the hardware system, but provides no sample sizes or data provenance (country of origin, retrospective/prospective) for such tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices, not for this hardware temperature management system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or AI/ML model output validation, which is not described here.

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 device is not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI algorithm in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth as typically understood in AI/ML validation is not relevant for this device. The "ground truth" for a temperature management system would be its ability to accurately and safely control patient temperature, which is assessed through engineering and functional testing, not diagnostic ground truth methods.

8. The sample size for the training set:
Not applicable. There is no AI/ML component that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. As above, there is no AI/ML component or training set.

In summary, the provided FDA 510(k) summary is for a traditional medical device (hardware for temperature management) and does not contain the information requested regarding acceptance criteria and studies for an AI/ML powered device. The document explicitly states "Clinical performance data to demonstrate substantial equivalence was not required." meaning the evaluation was based on non-clinical (engineering and functional) tests.

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The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes are used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the active electrode during electrosurgical procedures.

The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is designed for use with electrosurgical generators equipped with either continuity monitors or contact quality monitoring systems. The ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode is composed of a non-conductive border adhesive surrounding the entire conductive gel area to ensure full contact with the patient's skin, and a pre-attached cordset.

The provided document is a 510(k) summary for the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with explicit performance metrics.

Based on the document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance metrics. Instead, it relies on demonstrating compliance with recognized standards and biocompatibility.

• Acceptance Criteria (Implied from the document):

  • Performance equivalent to predicate device.
  • Compliance with AAMI / ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R)2012 A2:2010/(R)2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
  • Compliance with IEC 60601-2-2 Edition 5.0: 2009 (Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories).
  • Biocompatibility per ISO 10993-1:2009 (Biological Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process) for new patient contacting materials.
  • No new issues of safety or efficacy due to minor design changes (dimensions, construction).

• Reported Device Performance:

  • The document states, "The proposed devices are equivalent to the predicate devices in their technological characteristics and performance."
  • It also states, "Both devices demonstrate compliance with applicable sections of AAMI / ANSI ES60601-1:2005/(R) 2012 and C1:2009/(R)2012 A2:2010/(R)2012... and IEC 60601-2-2 Edition 5.0: 2009..."
  • "Materials analysis demonstrates the ConMed ThermoGard® and ThermoGard® Plus ABC Dispersive Electrode materials comply with the requirements of ISO 10993-1:2009 Biologica Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process."
  • "Design testing was performed to verify that none of the changed features would affect equivalence."
  • "New patient contacting materials were tested per ISO 10993 and verified to be biocompatible."

  Note: Specific quantitative performance metrics (e.g., impedance, temperature rise) against detailed acceptance limits are not provided in this summary. The "study" mentioned is effectively a series of non-clinical tests to verify compliance with standards and equivalence to the predicate.

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

The document does not specify a "test set" in the context of clinical data or a dataset with a specific sample size. The testing described is non-clinical (design testing, materials analysis, compliance with standards). Therefore, information on data provenance or whether it was retrospective or prospective is not applicable in this context.

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

This information is not applicable. The device's "ground truth" (compliance with safety and performance standards) was established through engineering design testing and materials analysis, not through expert consensus on a clinical test set.

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

This information is not applicable, as there is no mention of a human-adjudicated test set.

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 information is not applicable. The device is a medical accessory (dispersive electrode) and not an AI-driven image analysis or diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

This information is not applicable as the device is not an algorithm or AI system.

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

The "ground truth" for this device, in the context of this 510(k) submission, is established by:

• Compliance with recognized industry standards: AAMI / ANSI ES60601-1 and IEC 60601-2-2 for electrical safety and performance.
• Biocompatibility testing: Conformance to ISO 10993-1.
• Equivalence to a legally marketed predicate device: Demonstrating that the changes do not raise new safety or efficacy issues.

There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data in this summary.

8. The sample size for the training set:

This information is not applicable. The device is a physical medical accessory, not a machine learning model that requires a training set.

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

This information is not applicable for the reasons mentioned in point 8.

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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 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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dispersive electrode used for the dispersion and return to the electrosurgical generator of therapeutic (RF) energy introduced to the patient at the active electrode during electrosurgical procedures.

ConMed ThermoGard™ & ThermoGard™ Plus ABC Dispersive Electrodes

The provided text is a Medical Device 510(k) K972628 document from the FDA, dated August 27, 1997. It formally recognizes the substantial equivalence of the "ConMed ThermoGard™ & ThermoGard™ Plus ABC Dispersive Electrodes" for marketing.

This document does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications for the device. It is a regulatory clearance letter, not a study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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