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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 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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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 and pediatric 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 Temperature Management System (“System”) is a thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages. Unintended hypothermia can occur for many reasons, the most common clinically being the use of anesthetic drugs in surgery. Given the negative consequences of unintended hypothemia, active warming therapy is standard practice. The System can measure patient core temperature within the range of 31°C to 43 C° (87.8°F to 109.4°F). The System consists of the HotDog Temperature Management Controller (WC7X) and reusable Warming Blankets (BXXX) and Mattresses (UXXX).

The Controller includes:
7-inch touchscreen with intuitive user interface Ability to power multiple warming devices at once Integrated educational slide shows & positioning guides Adjustable settings

Additionally the controller monitors patient core temperature when receiving a signal from an Augustine YSI 400-compatible temperature probe. This requires at least a proprietary cable to make the connection. The Controller can also output the patient temperature to a third-party monitor (e.g., to port to the EMR).

AUTO mode is available if Warming Devices are placed on the patient and plugged-in, and a valid human temperature is measured/monitored. AUTO mode automatically adjusts the warming device temperature setting based on a user-selectable "Normothermia Zone" in increments described in the table below. The upper limit in the example below is set at 38 C and lower limit is set at 36 C for the Normothermia Zone (selectable in the Menu -Setting - Temperature Graph; the zone must extend 1°C or greater).

Blankets and mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass). They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. They are powered by a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.

The provided text describes specific acceptance criteria and the study conducted to prove that the device, the HotDog Temperature Management System, meets these criteria. This information is primarily found in the "Performance Data", "Further Bench Testing", and "Summary" sections of the document.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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 explicitly state the sample size for the test set or the data provenance (country of origin, retrospective/prospective). The studies mentioned are primarily "bench testing" and "usability studies," which typically involve controlled environments rather than broad clinical data sets.

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)

The document does not specify the number of experts or their qualifications for establishing ground truth. The studies relied on recognized consensus standards (IEC, ISO, ANSI AAMI) for performance and safety measurements, and a "Formative usability engineering study" and "Summative validation" for usability, but details about the experts involved are not provided.

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

The document does not describe any adjudication method for establishing a ground truth for a test set. This type of adjudication is typically used in studies involving subjective assessments, such as expert interpretation of medical images. The studies here are focused on objective performance and safety metrics.

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 comparative effectiveness study was done. The device is a "Thermal Regulating System" and not an AI-assisted diagnostic tool that would involve "human readers" interpreting data. Therefore, the concept of improving human readers with AI assistance is not applicable here.

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

The performance data discussed (e.g., electrical safety, temperature accuracy, software verification, AUTO mode functionality) are essentially standalone performance evaluations of the device's technical specifications and functionality, without direct "human-in-the-loop" performance as a primary outcome measure for these specific acceptance criteria. The usability study, however, does implicitly involve human interaction, but the "standalone" aspect refers to the device's inherent operation.

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

The ground truth for most of the acceptance criteria is based on:

• Recognized Consensus Standards: Compliance with international and national standards (e.g., IEC 60601-1, ISO 80601-2-56). These standards themselves represent established criteria and methodologies for determining performance and safety.
• Manufacturer Specifications/Design Control: The device meeting its own design specifications and functional requirements (e.g., AUTO mode functioning "according its own theory of operation," temperature probe compatibility tolerances).
• Bench Testing Results: Objective measurements obtained during controlled laboratory tests.
• Usability Study Findings: Observations and feedback from users during formative and summative usability studies, ensuring the device is intuituve and operates as intended by a user.

8. The sample size for the training set

The document does not mention a "training set" in the context used for AI or machine learning models. The device is a thermal regulating system, and its development and verification did not involve machine learning training sets.

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

As there is no mention of a training set for machine learning, this question is not applicable.

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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 Return Electrode Mattress is sold with a Return Electrode Cable, 4m (A136) that enables connection to one electrosurgical generator. The HotDog Return Electrode Mattress completes the circuit required for electrosurgery through Capacitive method. A capacitor is created when two conductive plates are separated by an insulator. The separation of two conductive plates by an insulator creates a capacitor. The insulator prevents current from flowing directly between the two plates, thereby avoiding the resistance which creates heat. With capacitive grounding, current from the active electrode produces a charge on the first conductive plate. This causes an equal (but opposite) charge to form on the second conductive plate. Current produced by the charge on the second plate produces electrical returns to the generator and completes the circuit.

The provided text describes a 510(k) premarket notification for a medical device called the "HotDog Return Electrode Mattress". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving new clinical efficacy through a comparative effectiveness study or complex AI validation study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/software performance or human-in-the-loop studies.

Specifically, the document states:

• Clinical Data: "Not required" (Page 5). This directly indicates that clinical studies, which would typically involve human subjects and the types of performance metrics you're asking about, were not part of this submission for substantial equivalence.
• The device is an electrosurgical accessory (a return electrode mattress), not a diagnostic AI device requiring complex performance metrics like sensitivity, specificity, or AUC, nor is it subject to MRMC studies.
• The "study" mentioned is "Designed bench and functional use testing in a porcine model as recommended by the FDA guidance Premarket Notification 510(k) Submission for Electrosurgical Devices for General Surgery to support substantial equivalence to the Predicate." This suggests engineering and safety testing, not a clinical performance validation against ground truth established by experts.

In summary, the provided text does not contain any of the information requested in your prompt's numbered points because the device and the nature of the 510(k) submission do not require such studies or data.

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The HotDog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The HotDog Temperature Management Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including, without limitation, operating, recovery, and emergency rooms and on medical/surgical floors.

The HotDog Temperature Management Controller is part of a System intended to prevent or treat hypothermia and to provide warmth to patients. The System should be used in circumstances in which patients could become cold. The HotDog Temperature Management Controller is designed to provide power to the HotDog warming devices and to control the devices to set temperature.

The provided text describes a 510(k) premarket notification for the "HotDog Temperature Management Controller." This is a medical device submission, and the focus is on proving substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing novel efficacy or diagnostic performance. Therefore, many of the requested categories for acceptance criteria and study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable in this context.

The document indicates that bench testing was performed to demonstrate substantial equivalence. The acceptance criteria for this type of submission are typically adherence to recognized performance standards and comparability to predicate devices in terms of technological characteristics and intended use.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The submission relies on "bench testing" and a comparison of technical specifications to predicate devices, not a clinical test set with human or patient data.
• Data Provenance: Not applicable. The assessment is based on engineering and performance evaluations against recognized standards and comparison to existing device specifications.

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

• Not applicable. This is not a study requiring expert-established ground truth for a test set. The evaluation is based on engineering principles and regulatory compliance.

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a temperature management controller, not an AI-assisted diagnostic or interpretative system.

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

• Not applicable. This is not an algorithmic device in the context of diagnostic performance. The "algorithm" here would be the control logic for temperature management, whose performance is validated through bench testing against established standards.

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

• Ground Truth: For this type of submission, the "ground truth" is adherence to established engineering and safety standards (e.g., IEC 60601 series) and the documented specifications and performance of the predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.

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

• Not applicable. There is no training set for this device.

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