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Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.

Global Healthcare SG has developed the CarbonCool® products as a portable, non-invasive body cooling solution designed to enhance temperature reduction for adult patients. The CarbonCool® also enables more widespread applications by reducing treatment cost and increasing treatment flexibility and accessibility. The CarbonCool® System is a single use passive body cooling solution designed for medical and comfort cooling purposes. The CarbonCool® System utilizes the MPad™ which consist of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material.

The provided text describes the CarbonCool System, a thermal regulating system, and compares it to a predicate device (EMCoolspad, K100071) to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria for specific device performance metrics or a study that rigorously proves the device meets those criteria with statistical data.

Instead, the document focuses on:

• Indications for Use: Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.
• Device Description: Portable, non-invasive body cooling solution using MPad™ (thermoplastic polyurethane filled with high thermal conductivity material) and pad holders.
• Mechanism: Optimizes heat exchange by minimizing ambient temperature interference and ensuring snug fit.
• Comparison to Predicate: Highlights similarities in regulation, product code, class, indications, materials (HypoCarbon®), technological characteristics (thermal regulating, non-invasive, patient surface cooling, permanent skin contact, thermal energy removal, temperature monitoring, rewarming function, compatible freezer details, imaging compatibility, shelf life), and general safety/effectiveness claims.
• Non-Clinical Testing: Biocompatibility and packaging integrity according to ISO and ASTM standards.
• General Performance Claims (Bench): "In-house testing confirms the high performance of the MPad™, surpassing traditional cooling methods like ice and water. The MPad™ withstands pressure and maintains durability over extended periods, ensuring reliability in critical situations."

Limitations in the provided text for answering the request:

• No specific numerical acceptance criteria are listed for performance (e.g., target temperature reduction, rate of cooling, duration of cooling effectiveness).
• No detailed study results or data are presented to quantify "high performance," "surpassing traditional methods," or "withstanding pressure and maintaining durability."
• No information on sample size for test or training sets, data provenance, expert involvement for ground truth, or adjudication methods.
• No mention of MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, based only on the provided text, I cannot complete the table or provide the requested study details. The document claims equivalence based on technical characteristics and general performance statements rather than specific, quantified performance acceptance criteria and a detailed study demonstrating their fulfillment.

If this were a real submission, a full demonstration of substantial equivalence would typically include:

• Specific performance goals/acceptance criteria (e.g., "device must reduce core body temperature by X degrees Celsius within Y minutes").
• Detailed protocols and results of performance testing against these criteria.
• Validation data where the new device's performance is quantitatively compared to the predicate device or established clinical benchmarks.

Given the information available, I can only create a table that summarizes the claims and types of testing mentioned, rather than specific acceptance criteria and detailed performance data.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document refers to "in-house testing" but gives no details about sample sizes, whether it was prospective or retrospective, or the country of origin of any data used for performance validation.

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

• Not applicable/Not provided. The document describes a physical medical device for temperature regulation, not an AI or diagnostic device that would typically involve experts establishing ground truth for a test set.

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

• Not applicable/Not provided. As above, this type of detail is typically relevant for diagnostic or AI-driven systems where expert consensus is needed to establish ground truth.

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 a physical thermal regulating system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm. However, its "standalone" performance implies the performance of the device itself without human intervention defining its core function (beyond application and monitoring). The document claims "in-house testing confirms the high performance of the MPad™" in this context.

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

• Not applicable / Performance-based. For a thermal regulating system, "ground truth" generally refers to quantitative measurements against engineering specifications and relevant physiological outcomes (e.g., actual temperature reduction in a controlled environment or in a simulated body). The document mentions "in-house testing" and "compliance with recognized standards" for biocompatibility and packaging, but does not detail the "ground truth" for its core cooling performance.

8. The sample size for the training set:

• Not applicable/Not provided. This is a physical device, not an AI model that requires a training set.

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

• Not applicable. As above.

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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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Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

The IQool™ System is a surface cooling device that sustains and monitors patient temperature within a range of 33°C to 37°C. The IQool™ System consists of: ECU 100 – refrigeration and control unit – The ECU 100 is a refrigerator unit with an integrated control system operated via a touch screen monitor. BC COOL- BC COOL is a cooling liquid consisting of diluted monopropylene glycol (MPG5). The dilution is made by BrainCool AB to optimally serve the IQool™ System. Five liters of BC COOL are delivered with the system. Cooling Pads – the single use cooling pads are the only skin contacting component and can be fitted to the head/neck, torso, and thigh. Liquid coolant is circulated from the tank through the pads to cool patients. The cooling pads are designed and molded to give a good fit during treatment and are intended for single patient use. Stabilization insulation – The patented stabilization insulation is made of insulating and moisture-absorbent neoprene. The stabilization insulation supports the cooling pads and insulates against the ambient environment condensation. The elasticity of the stabilization insulation keeps the Cooling Pads in place during treatment and ensures maximum cooling between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only. Accessories: BC STICK — The BC STICK is a USB flash drive used to save system configurations, specifically prepared to communicate with the program of the IQool™ System. The BC stick does not store or capture any user identifying information. It can also be used to save a log file for system troubleshooting or to update the software. Filling pitcher – The filling pitcher is for refilling the tank with BC COOL (coolant). Fill the tank with coolant before or directly after start to avoid damage to the system. The ECU 100 pushes temperature-controlled BC COOL ranging between 4°C and 30°C through the Cooling Pads at approximately 1.2 liter per minute per pad. This results in heat exchange between the BC COOL and the patient. Patient temperature is monitored by one or two commercially available third-party temperature probes. The IQool™ System maintains a controlled patient temperature during the entire treatment period. Any deviations from the default temperature are automatically adjusted by the system. The default treatment settings for temperature and time can be changed through the touchscreen monitor. Alarms and notifications are activated if any errors are detected. Temperature graphs for each treatment are shown on the touchscreen display for visual monitoring.

The provided text describes a medical device, "The IQool System," and its claim of substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the format typically used for AI/ML device evaluations (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on regulatory submission (510(k)) for a thermal regulating system and its comparison to a predicate device. The performance data section broadly states that "Testing was completed for the IQool™ System which demonstrated intended, labeled device performance," and lists various functional, temperature, software, and safety tests, as well as adherence to standards.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text, as this document type typically doesn't contain that level of detail for performance metrics, study design, or ground truth establishment relevant to AI/ML device evaluations.

Here's what can be inferred or stated about the device based on the provided text, recognizing its limitations regarding your specific questions:

Device: The IQool System (Thermal Regulating System)

Intended Use: Temperature reduction for adult patients where clinically indicated, e.g., in hyperthermic patients.

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

Note: The document broadly states "All testing confirmed that the IQool™ System operates as described and is substantially equivalent to the predicate device" in lieu of specific numerical performance outcomes for many criteria.

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

This information is not provided in the document. The document describes general performance testing and standards compliance, not a clinical trial or specific test set with patient data.

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)

This information is not provided in the document. The device is a thermal regulating system, not an AI diagnostic tool requiring expert ground truth for interpretation of outputs like images.

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

This information is not provided in the document. Not applicable for this type of device and testing described.

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 provided in the document. This is not an AI/ML diagnostic device with human reader interaction.

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

The device is a physical thermal regulating system. Its "performance" is based on its ability to control temperature as per its design. The document states it was functionally tested and meets standards, implying a standalone performance assessment of the device's physical and software functions. The "algorithm" in this context refers to its internal control system for temperature regulation, not an AI for interpretation.

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

For a thermal regulating system, "ground truth" would typically refer to:

• Reference temperature measurements: Calibrated temperature probes would act as the ground truth for measuring the patient's core temperature.
• System set points: The desired temperature set by the clinician would be the target "ground truth" for the device to achieve and maintain.
• Engineering specifications: Conformance to design specifications for cooling rates, fluid parameters, and safety elements.

The document states "Patient temperature is monitored by one or two commercially available third-party temperature probes." These probes would serve as the reference for patient temperature.

8. The sample size for the training set

This information is not provided in the document. This concept (training set) is typically relevant to AI/ML models, not purely electro-mechanical medical devices with control system software.

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

This information is not provided in the document. Not applicable given the type of device.

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Temperature reduction for adult patients where clinically indicated, e.g. in hyperthermic patients.

The EMCOOLSpad is a single use surface (skin) cooling device, which is adherent to the patien's skin and so highly adjustable during the cooling procedure. An EMCOOLSpad consists of multiple cooling-cells made of thermoplastic polyurethane, filled with high thermal conductivity material, stored frozen at 0 to -10°C.

The provided text describes the EMCOOLSpad, a hypothermia system, and its substantial equivalence to predicate devices, but it does not contain information related to acceptance criteria, specific clinical studies with performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC studies.

The document focuses on:

• Device Description: How the EMCOOLSpad works as a single-use surface (skin) cooling device.
• Comparison to Predicate Devices: A table outlining shared technological characteristics with the Arctic Sun® Model 2000 and Thermosuit™ Hypothermia System, concluding substantial equivalence based on functional criteria.
• Biocompatibility Testing: Performed according to ISO standards by an accredited lab.
• Performance Testing - Bench: Internal R&D testing showed no difference in cooling rate compared to ArcticSun®, and it was less aggressive than ThermoSuit™, suggesting better physiological tolerance.
• Performance Testing - Animal: Demonstrated "under-the-pad" skin safety on pigs after 24 hours and 1 week.
• Conclusion: The device performs as intended and raises no new safety or effectiveness issues.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as that information is not present in the provided text.

Based on the provided text, there is no information available to answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or clinical performance metrics. The document is a 510(k) summary focused on demonstrating substantial equivalence through device description, comparison to predicates, and limited non-clinical testing (biocompatibility, bench, and animal studies for skin safety).

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The ThermoSuit System™ is a thermal requlating system.
Indications for Use are
a. Temperature reduction in patients where clinically
indicated, e.g. in hyperthermic patients;
b. Monitoring of patient temperature.

The ThermoSuit System (TSS) is a device that allows rapid patient cooling by the circulation of cold water in direct contact with the skin of the patient. Patient temperature measurements control the extent and duration of cooling, by controlling pump output and drainage of cooling fluid. Temperature measurements and associated alarm signals are designed to prevent overcooling.

The ThermoSuit System™ consists of the following main components:

• . ThermoSuit Body Enclosure
• Multi-lumen Umbilicus Hose .
• . Reservoir/Pump Assembly
• . Pump Controller Console
• . Other Components

Here's an analysis of the acceptance criteria and study information for the ThermoSuit System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define numerical acceptance criteria (e.g., cooling rate target, temperature accuracy range) or quantifiable performance metrics for the ThermoSuit System. Instead, the performance testing focuses on functional verification and comparison with a predicate device.

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

• Human Volunteers (for suit optimization): Sample size not specified.
• ThermoSuit Body Enclosures (mechanical integrity): "All suits" implies the entire production batch or a representative sample from it. Sample size not specified quantitatively.
• Functional Testing (new and aged components): Sample size not specified quantitatively for components, but refers to "ThermoSuit System" and "ThermoSuit Body Enclosures."
• Comparative Cooling Bench Study:
  • Test Set: One "Heated Mannequin."
  • Data Provenance: Benchtop study (laboratory setting).
• Animal Study:
  • Test Set: "Large pigs." Sample size not specified quantitatively.
  • Data Provenance: Animal study (presumably in a controlled laboratory or research facility).
• Design Validation (User Testing):
  • Test Set: Four (4) Users, completing a total of nine (9) test runs.
  • Data Provenance: User testing, likely in a simulated clinical or laboratory environment.
• Data Provenance (overall): Primarily internal testing (bench, animal, user validation). Country of origin is not specified, but the company is US-based (Kinnelon, NJ), suggesting US provenance. All studies appear to be prospective.

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

• For the technical and functional performance tests (mechanical integrity, pump/controller, software), the "ground truth" would be established by the engineering and testing protocols themselves, not typically by experts in a clinical sense.
• For the cooling studies (mannequin and animal), the ground truth is the actual measured temperature change and cooling rates. This is a direct measurement, not an expert consensus.
• For the user validation test, the ground truth for understanding the manual and device operation was established through a "detailed questionnaire" answered by the four users. Their qualifications as "Users" are not further specified (e.g., nurses, technicians, physicians), but they are implied to be representative of target operators.

4. Adjudication Method for the Test Set:

Not applicable in the conventional sense. The studies described are primarily objective measurements (temperature, pressure, functional checks) or direct user feedback (questionnaire). There's no mention of subjective interpretation of results requiring adjudication by multiple readers or evaluators.

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

No, an MRMC study was not done. The comparative studies involved the device and a predicate device in bench and animal models, not human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The ThermoSuit System is a medical device that involves direct interaction with a patient and a human operator. Its "performance" isn't a standalone algorithm in the way an AI diagnostic tool would be. The closest equivalent would be the automated functions of the pump controller and software. The document states:

• "Performance testing of the ThermoSuit System included a full evaluation of the Pump/Controller functions and software validation; the results conformed to the device specifications."
  This indicates that the automated control aspects were tested for their inherent functionality according to specifications, representing a form of standalone performance for the automated components.

7. The Type of Ground Truth Used:

• Objective Measurements: For mechanical tests (pressure), functional tests (pump/controller, software), and cooling studies (temperature reduction, cooling rate).
• Test Specifications: The device was tested against its own "performance specifications" and "design parameters."
• User Feedback: For understanding of the Operator's Manual and device operation in the design validation.
• Compliance with Standards: For biocompatibility, electrical safety, and electromagnetic compatibility.
• Comparison to Predicate Device: For cooling effectiveness, where the predicate device's performance served as a benchmark for "comparable" results.

8. The Sample Size for the Training Set:

This device is not an AI/ML algorithm that requires a "training set" in the computational sense. The development and optimization processes of the ThermoSuit System likely involved iterative design, prototyping, and testing (including the human volunteer testing for suit dimensions/operating parameters), which could be considered analogous to "training" in an engineering context, but not a data-driven training set for an algorithm. No specific sample sizes for such iterative development are provided here.

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

As above, there is no "training set" in the AI/ML context for this device. The development process would have involved engineering design principles, physical testing, and potentially user feedback during various stages to refine the product, with "ground truth" being established by physical measurements, functional requirements, and design specifications.

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