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Celsi Warmer is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates.

a. Maintain pre-set body temperature as determined by the physician.
b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg.
c. Monitoring and controlling patient temperature.

The Celsi Warmer is a portable, non-invasive thermal regulating system, indicated for continuous temperature monitoring and thermal treatment of neonates that require extra warmth to maintain normal body temperature. It uses a non-invasive thermometer (using direct mode) that measures the temperature of an infant's skin via a temperature probe placed on their abdomen to provide input into a physiological control loop that controls the mattress temperature. The Celsi Warmer is intended for use in hospitals under a clinician's supervision and is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg. The Celsi Warmer is comprised of the following components:

• Warming Mattress
• Controller Tower
• Celsi Temperature Probe and Celsi Belt
• Power Supply and Cables

I apologize, but the provided text from the FDA 510(k) Clearance Letter for the Celsi Warmer does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.

The document focuses on:

• Formal FDA clearance: Confirmation of the 510(k) submission, product classification, and general regulatory requirements.
• Device description and indications for use: What the Celsi Warmer is and what it's intended for.
• Comparison to a predicate device: Highlighting similarities in intent, technology, and use environment.
• Summary of non-clinical testing: A list of standards and types of testing performed (Biocompatibility, Software V&V, EMC/Electrical Safety, Usability).

However, it does not include:

1. A table of specific acceptance criteria and reported device performance: While it mentions testing, it doesn't provide the quantifiable metrics or the results of those tests.
2. Sample sizes for a test set, data provenance, ground truth establishment, or expert details for performance studies.
3. Details about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Information on training set sample sizes or ground truth for training data.

The 510(k) summary typically provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (like those involving expert human readers or specific statistical analyses) are usually found in the full 510(k) submission document, which is not publicly available in this format from the clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions based solely on the provided text.

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The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.

The Arctic Sun™ Stat Temperature Management System is a non-invasive, thermal regulating device that monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to 101.3°F). The system consists of a console, non-sterile single patient use ArcticGel™ Pads, and associated accessories.

The Arctic Sun™ Stat Temperature Management System circulates temperature-controlled water ranging between 4°C and 40°C (39.2°F and 104°F) through the ArcticGel™ Pads, resulting in heat exchange between the water and the patient. A commercially available Yellow Springs Instrument (YSI) 400 series compatible patient temperature probe connected to the console provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician. The Arctic Sun™ Stat console has the option to provide secure data output of device monitoring values; there is no patient-identifiable information. The data output functions, including USB, RS-232, and Wi-Fi, do not allow the user to write to the device and are intended for user convenience only.

The provided FDA 510(k) clearance letter for the Arctic Sun Stat Temperature Management System does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, or ground truth establishment for a clinical or performance study that would typically be associated with an AI/ML device clearance.

This document describes a regulatory submission for a device that has undergone software modifications and other minor changes, primarily relating to alarms, Wi-Fi support, and software anomaly corrections. The clearance is based on substantial equivalence to an existing predicate device (which is, in fact, the same device but an earlier version, K200225).

The submission emphasizes non-clinical testing and states that "No clinical testing was required to evaluate substantial equivalence." This is a key point: detailed human reader studies or extensive clinical data would generally NOT be required for a 510(k) based on substantial equivalence for this type of device (a thermal regulating system), especially when the changes are software-based and don't alter the fundamental mechanism of action or indications for use.

Therefore, many of the requested points in your prompt are not applicable (N/A) based on the information provided in this 510(k) summary. The acceptance criteria and "studies" are focused on engineering verification and validation rather than clinical performance with human-in-the-loop or standalone AI performance against a ground truth.

Here's how to address your prompt based on the provided text:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" and "study" in this context refer to the non-clinical performance testing and verification/validation activities conducted to demonstrate that the modified Arctic Sun Stat Temperature Management System remains safe and effective, and is substantially equivalent to its predicate device. Since this is a hardware device with software modifications, the focus is on maintaining previously established performance, reliability, and safety characteristics.

The overarching acceptance criterion is demonstrating substantial equivalence to the predicate device (K200225) without raising new questions of safety or effectiveness. This is achieved through a suite of non-clinical tests.

Summary of Device Performance: The document states, "The results from this testing demonstrate that the technological characteristics and performance criteria of the subject device are substantially equivalent to the predicate device and performs in a manner equivalent to devices currently on the market for the same intended use."

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for software and minor hardware modifications to an existing device, the "acceptance criteria" are more akin to successful completion of verification and validation against specified design requirements and FDA-recognized standards, rather than clinical performance metrics in humans.

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

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers. For non-clinical testing, "samples" would refer to the number of devices or components tested. The document lists "Artificial patient testing," which would imply a simulated environment, not human subjects. Therefore, the "sample size" for patient data is N/A (not applicable, as no clinical patient data was used for testing equivalence).
• Data Provenance: N/A (no clinical patient data used). The testing was conducted internally by Medivance, Inc.

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

• N/A: No ground truth in the context of expert consensus on medical images or diagnoses was established as this was not an AI diagnostic device or clinical study. The "ground truth" for non-clinical testing is adherence to engineering specifications, safety standards, and performance benchmarks established during the device's original development (and maintained through these modifications).

4. Adjudication Method for the Test Set

• N/A: No clinical adjudication process was performed for patient data, as no clinical patient data was used. Adjudication in this context would refer to internal quality assurance and design control processes.

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

• No, N/A: An MRMC comparative effectiveness study was not performed. This type of study is typical for AI-powered diagnostic imaging devices to assess the impact of AI on human reader performance. As a thermal regulating system, this is not relevant to its regulatory pathway or the type of changes involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Yes, in spirit (but not as a diagnostic AI model): The "Software verification," "Control accuracy and precision," and "Alarm functionality" tests represent the standalone performance of the device's algorithms and internal logic. These tests ensure the automated control and monitoring processes (the 'brains' of the device) function correctly as programmed, without direct human intervention during the measurement/control cycle itself. However, this is not an "AI diagnostic algorithm" in the typical sense of a standalone output for diagnosis.

7. The Type of Ground Truth Used

• Engineered Specifications and Standards: The "ground truth" for this device's performance validation is its design specifications, pre-established performance benchmarks, and compliance with applicable FDA-recognized consensus standards (e.g., for electrical safety, EMC, software validation, cybersecurity). For specific functionalities like temperature control, the "ground truth" is the accurate and precise maintenance of temperature within the specified range (32°C to 38.5°C), verified using calibrated equipment (e.g., in artificial patient testing).

8. The Sample Size for the Training Set

• N/A: As this device is not an AI/ML device that requires a "training set" in the common sense of machine learning, this concept does not apply. The control algorithm is likely rule-based or uses traditional control theory, not a learned model from data.

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

• N/A: See point 8.

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The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not mantain a state of normothermia. The System can be used with adult patients.

The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.

The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one or two electrosurgical units (ESU) or generators in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The HotDog Return Electrode Mattress is intended for use with adult patients only.

The HotDog Warming Mattress + Return Electrode (“Mattress") is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.

Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.

Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

The provided text describes a 510(k) premarket notification for the "HotDog Warming Mattress + Return Electrode." This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than performance data derived from an AI/ML-based device that would require a study with acceptance criteria, a test set, and human expert adjudication.

Therefore, the requested information, specifically regarding "AI vs without AI assistance," "standalone performance," "human readers," "ground truth," training/test sets, and expert consensus, is not applicable to this document as it pertains to a physical medical device (warming mattress and return electrode) and not an AI/ML diagnostic or therapeutic device.

The document discusses bench testing to demonstrate compliance with FDA-recognized consensus standards and to show substantial equivalence to the predicate device.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with quantifiable metrics for a "device performance" in the way one would for an AI/ML diagnostic. Instead, it describes compliance with recognized consensus standards and general safety/performance characteristics.

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

• Sample Size: Not applicable in the context of clinical data or AI/ML testing. The "tests" here refer to bench tests on the physical device. The document does not specify the number of devices or test conditions for the bench testing beyond stating "bench testing was performed."
• Data Provenance: The bench testing was "underwritten by Intertek." This implies a third-party laboratory conducted the tests. The document does not specify the country of origin of the data beyond this. It's a retrospective assessment of the device's characteristics against predefined standards.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for this physical device's regulatory review. The "truth" is established by compliance with engineering and safety standards.

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

• Not applicable. This is a bench test evaluation, not a clinical study involving reader performance and 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:

• Not applicable. This device does not involve AI or human reader assistance.

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

• Not applicable. This is not an algorithm-based device.

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

• The "ground truth" for this device's evaluation is adherence to recognized consensus standards for medical electrical equipment safety, electromagnetic compatibility, thermal regulation, and electrosurgical accessories. This is established through established engineering and testing methodologies, not clinical expert consensus on specific cases.

8. The sample size for the training set:

• Not applicable. There is no AI/ML model being trained.

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

• Not applicable. There is no AI/ML model being trained.

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The Cocoon Convective Warming System, Model CWS7000, is indicated for patient warming. The Cocoon Convective Warming Unit, Model CWS7000 has been designed for use with Cocoon Disposable Patient Warming Gown Blankets. It is intended for use with children, adolescent, and adult patients.

The Cocoon Convective Warming System, Model CWS7000 is part of the Cocoon family of temperature management systems that consists of portable forced-air temperature management units, Cocoon™ Disposable Patient Warming Gown Blanket.

The Cocoon Convective Warming System, Model CWS7000 comprises of the Cocoon Convective Warming Unit, Model CWS7000 unit and the Cocoon™ Disposable Patient Warming Gown Blankets. The Cocoon Convective Warming System, Model CWS7000 can be used in preoperative and postoperative settings. In a preoperative setting, the warming system provides prewarming and comfort warming. In a postoperative setting, the warming system provides comfort warming only. The Cocoon Convective warming system should be used by trained medical professionals only.

The Cocoon™ Convective Warming System, Model CWS7000 is not intended for use in the operating room.

The provided text describes the regulatory clearance for the Cocoon Convective Warming System, Model CWS7000. It includes a summary of nonclinical testing but explicitly states that clinical testing is not applicable. Therefore, I can provide information based on the nonclinical testing, but there is no study described that proves the device meets acceptance criteria through clinical performance.

Here's an analysis based on the provided text, focusing on what's available and noting what is not applicable:

Acceptance Criteria and Reported Device Performance (Nonclinical)

The acceptance criteria for the Cocoon Convective Warming System, Model CWS7000 are based on compliance with various international standards for medical electrical equipment, electromagnetic compatibility, software life cycle processes, heating devices, biological evaluation, and risk management. The reported performance is simply "Pass" or "Meets requirements" for each of these standards.

Study Details (for nonclinical testing as clinical testing was not applicable)

• Sample size used for the test set and the data provenance: Not specified in terms of patient data, as clinical testing was deemed not applicable. The sample size for nonclinical engineering and safety tests would refer to the number of units or components tested, which is not detailed but assumed to be sufficient for compliance with the listed standards. Data provenance is not applicable as it's not a study involving human or animal data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For nonclinical standards compliance, "ground truth" is established by the specifications and requirements of the standards themselves. The testing would be conducted by qualified engineers and technicians.
• Adjudication method for the test set: Not applicable for nonclinical standards testing. Compliance is determined by whether the device meets the specified parameters and requirements of each standard.
• If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating observer performance with medical images or clinical judgment, which is not relevant to a convective warming system.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided information refers to the device itself (hardware and embedded software), not a standalone algorithm. The device's performance was evaluated independently against the standards.
• The type of ground truth used: For this device, the "ground truth" for demonstrating performance is derived from the requirements and specifications of the referenced international technical and safety standards (e.g., IEC 60601-1, IEC 60601-2-35, ISO 10993-1). These standards define acceptable levels for electrical safety, electromagnetic compatibility, temperature control accuracy, biocompatibility, and risk management.
• The sample size for the training set: Not applicable, as this is not an AI/ML-based device that undergoes a training phase with a dataset.
• How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

In summary, the provided document focuses on the regulatory clearance of a medical device based on its compliance with established nonclinical safety and performance standards, rather than clinical efficacy studies or AI performance metrics.

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The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient themal comfort when conditions exist that may cause patients to feel too warm or too cold. The temperature management system can be used with adult and pediatric patients.

The Medline ComfortTemp Patient Warming System is intended to prevent and treat hypothermia. In addition, the patient warming system provides thermal comfort when conditions exist that may cause patients to feel too warm or too cold. The patient warming system is for adult and pediatric patients. The Medline ComfortTemp Patient Warming System is used in acute care, post-acute care, operating room, and procedural rooms. The system consists of a reusable blower unit, a reusable hose, and single-patient use, disposable blankets. Replacement filters and hoses for the blower unit are additionally available as needed. All components of the ComfortTemp Patient Warming System are non-sterile. The blower unit connects to the single-patient use blanket through a reusable hose and provides forced warm air into the blanket using a PTC (positive temperature coefficient) heater, a fan/blower and a user-controlled interface. Depending on the model, the ComfortTemp blanket is placed either around, over, or underneath adult and/or pediatric patients. The blanket is comprised of two polypropylene and polyethylene layers, which allow the forced warm air to be dispersed over the patient's skin.

This document describes the FDA clearance for the Medline ComfortTemp Patient Warming System, declaring it substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in terms of a digital health or AI/ML device.

The document discusses various performance tests conducted on the device, such as airflow testing, temperature verification, material strength, and biocompatibility. However, these are engineering and safety tests rather than performance evaluations against clinical acceptance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or expert involvement as these details are not present in the provided text. The text does not describe an AI/ML device or a study with such methodologies.

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The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use.

The FilteredFlo warming blankets are used with the IOB Temperature Management System (previously cleared K231596) that draws ambient- temperature air through a 0.2 micron particulate air filter. The filtered air is warmed to a selected temperature. The warmed air enters the FilteredFlo Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient.

The FilteredFlo warming blankets in the submission are the following:

FF-243 ADULT/PACU BLANKET
FF-244 PEDIATRIC BLANKET
FF-246 INFANT UNDERBODY BLANKET
FF-247 LARGE PEDIATRIC UNDERBODY BLANKET
FF-248 ADULT UNDERBODY BLANKET
FF-443 UPPER BODY BLANKET
FF-442 LOWER BODY BLANKET
FF-344 TORSO BLANKET
FF-145 WARMING TUBE BLANKET

These blankets are single-use and disposable. Each blanket consists of two layers of nonwoven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The provided document is a 510(k) summary for a medical device called "FilteredFlo Warming Blankets." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to software, artificial intelligence (AI), diagnostic performance, or extensive clinical studies that would typically have the requested details about acceptance criteria for AI models, human reader studies, ground truth establishment, or training/test set sizes.

The "studies" mentioned are primarily non-clinical tests to demonstrate that the new warming blankets perform equivalently to existing ones in terms of physical characteristics and safety, not diagnostic accuracy or AI performance.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI or diagnostic performance, as these are not relevant to the "FilteredFlo Warming Blankets" device as described in this 510(k) submission.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to your request, but highlighting the absence of AI/diagnostic-specific details:

Device: FilteredFlo Warming Blankets (models FF-243, FF-244, FF-246, FF-247, FF-248, FF-443, FF-442, FF-344, FF-145)

Intended Use: "The FilteredFlo Warming Blanket is intended to be used with the IOB-507 patient warming system. The IOB-507 Temperature Management system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. These blankets are intended for adult and pediatric use."

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

   Since this is a thermal regulating system and not an AI or diagnostic device, the "acceptance criteria" are related to physical and functional equivalence to a predicate device, specifically in terms of temperature uniformity, package integrity, and lack of leaks.

   Acceptance Criteria	Reported Device Performance
   Temperature Uniformity	All test results show temperature uniformity "equivalence" between the FilteredFlo Warming Blankets and the predicate at different IOB Warmer settings.
   Simulated Transport Testing (ASTM D4169)	No package damage was observed. All products held integrity after the transport testing.
   Bubble Testing (ASTM F2096) (Leakage)	No leakage was found.
   Biocompatibility	Tests for biocompatibility were reported in the previously cleared K231596 (predicate device's clearance). The proposed device is implicitly accepted as biocompatible based on previous clearance.
   Material Design and Indication for Use Equivalence	The proposed device's material design and Indications for Use are deemed "Substantially Equivalent" to the predicate device.

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

   • Sample Size: Not explicitly stated for each test, but implied to be a representative sample of the different blanket models. These are physical product tests, not data-driven studies with "test sets" in the AI sense.
   • Data Provenance: Not specified, but these are laboratory/bench tests performed by the manufacturer or their contractors.

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. "Ground truth" in this context refers to established engineering standards and physical measurements, rather than expert diagnostic consensus.

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

   Not applicable. These are engineering and physical product tests, not qualitative assessments requiring adjudication. The results are based on objective measurements against defined criteria.

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 warming blanket, not an AI or diagnostic tool. No MRMC study was performed or is relevant.

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

   Not applicable. This is a physical medical device, not an algorithm.

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

   The "ground truth" for demonstrating performance is derived from established engineering standards (e.g., ASTM standards for transport and bubble testing) and physical measurements (e.g., temperature measurements for uniformity). Comparison to the predicate device's cleared performance serves as the benchmark for "equivalence."

8. The sample size for the training set

   Not applicable. This device does not involve a "training set" for an algorithm.

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

   Not applicable.

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The IQool System is a thermal regulating system indicated for monitoring and controlling patient temperature.

The IQool™ System is a non-invasive, thermal regulating system that monitors and controls patient temperature within a range of 33°C to 38.5°C (91.4°F to101.3°F).

The IOooL™ System consists of:

• ECU 100 Refrigeration and Control Unit an integrated control system operated via a . touch screen monitor.
• BC COOL 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 Cooling Pads are made of non-sterile, biocompatible material and do ● not contain latex. The Cooling Pads are intended for single use only.
• . Stabilization Insulation - The patented stabilization is made of insulating and moisture-absorbent neoprene. It insulates against the ambient environment while counteracting condensation. The elasticity of the stabilization keeps the Cooling Pad in place during treatment and ensures maximum contact between the skin and the surface of the Cooling Pad. The stabilizing insulation is intended for single use only.

Accessories:

• BC Stick 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 should be used to fill or refill the coolant tank. Fill the tank with coolant before or directly after starting to enable start of the system.

The IQool™ System is a thermoregulatory device that monitors and controls patient temperature within a range of 33°C to 38.5°C. The IQool System refrigeration and control unit (ECU 100) pushes a temperature-controlled cooling agent (BC COOL), ranging between 4°C and 40°C, through the Cooling Pads applied to the patient. This results in heat exchange between the BC COOL and the patient. Patient core temperature is monitored and controlled based on the temperature probe (PT1) attached to the system. The IQool™ System maintains a controlled patient temperature during the entire treatment period. The default treatment settings for temperature and time can be changed via 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. After a treatment, a detailed log file can be collected with the memory stick (BC STICK).

This is a 510(k) premarket notification for a medical device called The IQool System, which is a thermal regulating system. The document states that a special 510(k) was submitted for "software changes," implying that the device itself has not fundamentally changed but its software has been updated. The submission aims to demonstrate substantial equivalence to a predicate device (K180375 IQool Warm System).

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. It primarily focuses on the regulatory submission process, device description, and a claim of substantial equivalence based on "testing summaries" for software changes.

Therefore, I cannot provide a table of acceptance criteria or details regarding a study as requested, because this information is not present in the provided document. The document only mentions that "testing summaries provided document that the changes were verified and that the subject device provides the same temperature management performance and safety as the predicate device," but it does not elaborate on what these tests entailed, their results, or the acceptance criteria used.

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The Barrier EasyWarm Active Self-Warming Blanket is intended to help prevent hypothermia by providing warmth to the patient during the perioperative period.

The Barrier EasyWarm Active Self-Warming Blanket is a non-sterile, single use blanket that is intended to prevent hypothermia by providing warmth to the patient during the period. The blanket contains warming pads (or heating elements) that are contained within sealed pouches that are advantageously positioned and sewn into the blanket's fabric for appropriate distribution of heat. The warming pads contain iron, active coal, water, salt, clay with a sodium polyacrylate cover. The device is supplied in a vacuum sealed packaging. Once the blanket is removed from its packaging, the blanket produces heat via an exothermic chemical reaction that takes place within the warming pads upon exposure to air. The chemical reaction results from the oxidation of iron.

This document does not contain information about an AI/ML device, nor does it provide the specific details required to complete your request about acceptance criteria and study data for an AI/ML device.

The document is a 510(k) summary for a Barrier EasyWarm Active Self-Warming Blanket, a medical device intended to prevent hypothermia by providing warmth to patients. It discusses modifications to a previously cleared device (K132048).

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample sizes, data provenance, or details about test and training sets for an AI/ML device.
3. Information on experts or adjudication for ground truth for an AI/ML device.
4. MRMC studies or effect sizes for AI assistance.
5. Standalone performance for an AI algorithm.
6. Types of ground truth for AI.

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The IOB Temperature Management System Model IOB-507 is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated.

The IOB Temperature Management System Model IOB-507 consists of the IOB Warming Unit and the IOB Warming Blankets. The IOB Warming Unit, model IOB-507, draws ambient- temperature air through a 0.2 micron air filter. The filtered air is warmed to a selected temperature. The warmed air enters the IOB Warming Blanket through the hose and is distributed through delivery channels. Perforations on the patient side of the air delivery channels in the warming blanket gently disperse the warmed air over and around the patient. The warming unit has three temperature settings of 32℃, 38℃, and 43℃. These temperature settings are servo-controlled by a thermistor placed at the end of the hose where the hose connects to the blanket. The unit can also deliver ambient-temperature air. The temperature indicated on the control panel is the temperature of air being delivered to the average contact surface temperature of the blanket. A control thermistor in the warming unit adjusts the power applied to the heater to maintain the selected temperature. This enables the unit to maintain the selected temperature under variations in ambient temperature. Besides, the warming unit has high and low air flow options. A safety thermistor provides a signal to a separate high-temperature analog circuit. The safety thermistor activates and produces an alarm if the temperature exceeds the set point. The analog safety circuit provides an independent means of shutoff, which discontinues power to the heater and motor. This prevents patient exposure to excessive temperatures. IOB warming blankets are single-use and disposable. Each blanket consists of two layers of non-woven polypropylene fabric coated with a layer of polyethylene. The layers are bonded together to form a distribution network of air delivery channels. The warm air is distributed around the blanket through the delivery channels and exits the blanket through a specially designed series of perforations in the patient side of the blanket.

The document describes the IOB Temperature Management System Model IOB-507, which includes the IOB Warming Unit and IOB Warming Blankets. The system is indicated for hypothermic patients or normothermic patients for whom induced hyperthermia or localized increase in temperature is clinically indicated. The device is a Class II device with product code DWJ (Thermal regulating system).

No clinical studies were performed. The device's substantial equivalence determination is based on non-clinical tests. Therefore, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of human performance or clinical outcomes.

However, based on the non-clinical tests mentioned, we can infer some performance characteristics and the tests conducted to demonstrate them.

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

Since no specific acceptance criteria for clinical performance are provided, this table focuses on the performance characteristics assessed through non-clinical testing.

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 provide details on the sample size for non-clinical tests (e.g., how many units of the warming unit or blankets were tested for each criterion). The data provenance is not mentioned, but as these are non-clinical (laboratory) tests, the concept of "country of origin of the data," "retrospective," or "prospective" as typically applied to clinical studies is not directly relevant. These tests would have been performed in a controlled laboratory environment by the manufacturer or a third-party testing facility.

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 applicable. The non-clinical tests described (electrical safety, temperature accuracy, material stability, etc.) do not involve human interpretation or the establishment of ground truth by clinical experts. These are objective engineering and material science tests.

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

This information is not applicable. Adjudication methods are relevant for clinical studies or image interpretation tasks performed by multiple human readers, which is not the case 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

No MRMC study was done, as this device does not involve AI or human readers for diagnostic interpretation. It is a temperature management system.

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

This information is not applicable. The device is a physical temperature management system, not an algorithm.

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

This information is not applicable. The non-clinical tests described use objective physical measurements and established engineering and material science standards (e.g., IEC, ASTM, ISO) as their "ground truth" or reference for evaluating performance.

8. The sample size for the training set

This information is not applicable, as this is a non-AI/ML device.

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

This information is not applicable, as this is a non-AI/ML device.

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The HotDog Temperature Management System is intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients may not maintain a state of normothermia. The System can be used with adult patients.

The System is intended primarily for use in hospital centers including, without limitation, operating rooms, recovery rooms, emergency rooms, burn units and on other medical/surgical floors.

The HotDog Return Electrode Mattress is intended to conduct monopolar electrosurgical energy from the target tissue of a patient back to one electrosurgical unit (ESU) or generator in monopolar surgery. The HotDog Return Electrode Mattress is restricted to use with isolated monopolar electrosurgical generators. The Hotdog Return Electrode Mattress is intended for use with adult patients only.

The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.

Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.

Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

The provided document is a 510(k) Premarket Notification summary for the HotDog Warming Mattress + Return Electrode. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the kind of studies typically discussed for AI/ML-based diagnostic devices (e.g., MRMC studies for image analysis).

Therefore, the requested information, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9, which are standard for evaluating AI/ML algorithm performance for diagnostic purposes, are not applicable to this document. This submission primarily relies on bench testing, adherence to recognized consensus standards, and risk management to demonstrate safety and effectiveness.

Here's why many of your specific questions are not directly answered by this document:

• No AI/ML Algorithm: The device described is a physical warming mattress with an integrated return electrode. It's not an AI/ML diagnostic or predictive algorithm. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," or "human readers improve with AI vs without AI assistance" are not relevant.
• Focus on Substantial Equivalence: The 510(k) pathway requires demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing of physical characteristics and performance against established standards, rather than clinical efficacy trials involving "ground truth" derived from expert consensus on images or pathology.

However, I can extract the relevant information regarding the performance claims and the studies/testing cited to support them, reframing the acceptance criteria in terms of the standards and tests performed.

Acceptance Criteria and Device Performance for HotDog Warming Mattress + Return Electrode

The "acceptance criteria" for this device are primarily defined by its compliance with recognized consensus standards for medical electrical equipment and specific standards for warming blankets/pads and high-frequency surgical accessories. The "study that proves the device meets the acceptance criteria" refers to the bench testing and risk management activities conducted.

1. Table of Acceptance Criteria and Reported Device Performance

For points 2-9, as this is a traditional medical device (not AI/ML software), these concepts are not applicable in the way they relate to AI model validation. However, I will address them where analogous information can be inferred from the document.

2. Sample Size Used for the Test Set and Data Provenance:
* "Test Set" Analogue: For this device, the "test set" is the actual device (or representative samples) subjected to various bench tests. The document doesn't specify a numerical sample size for each test (e.g., how many warming mattresses were tested for electromagnetic compatibility).
* Data Provenance: The testing was conducted by Intertek, a recognized third-party testing laboratory. The document indicates validation on porcine tissue at the University of Minnesota's Visible Heart Laboratory. This suggests prospective, controlled laboratory/animal testing, rather than retrospective human clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* This question is not applicable. The "ground truth" for a physical device like this is dictated by established engineering standards (e.g., specific voltage limits, temperature accuracy, current flow parameters) and material properties, rather than human expert interpretation of images or clinical outcomes that require medical consensus.

4. Adjudication Method for the Test Set:
* This is not applicable. Testing against engineering standards involves objective measurements and pass/fail criteria, not subjective human judgment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:
* This is not applicable. This device is not an AI/ML diagnostic tool, and thus no MRMC study with human readers assisting AI was performed or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* This is not applicable. There is no AI algorithm to test in a standalone fashion. The "standalone" performance here refers to the device's functional tests (warming, electrosurgical return) in isolation and in combination. The testing confirmed that warming and return electrode functions perform as intended both independently and when integrated.

7. The Type of Ground Truth Used:
* The "ground truth" for this device's performance is objective measurement against industry-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62366-1) and internal design specifications, supplemented by animal model validation (porcine tissue) for the combined functionality. It's not based on expert clinical consensus or patient outcomes data in the way an AI diagnostic model would be.

8. The Sample Size for the Training Set:
* This is not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:
* This is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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