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510(k) Data Aggregation
(176 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with ANSI AAMI ES60601-1 and IEC 60601-1-2. | Bench testing, underwritten by Intertek, was performed. The device is designed and verified to meet ANSI AAMI ES60601-1, A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 and IEC 60601-1-2, edition: 4.0. |
| Safety of Blankets, Pads, and Mattresses: Compliance with IEC 80601-2-35. | The device is designed and verified to meet IEC 80601-2-35, edition: 2.1. |
| Basic Safety and Essential Performance of Clinical Thermometers: Compliance with ISO 80601-2-56. | The device is designed and verified to meet ISO 80601-2-56, second edition. |
| Requirements for Physiologic Closed-Loop Controllers: Compliance with IEC 60601-1-10 (for AUTO mode functionality). | The device is designed and verified to meet IEC 60601-1-10, edition 1.1. Further bench testing showed that AUTO mode functions according to its own theory of operation. |
| Alarm Systems: Compliance with IEC 60601-1-8. | The device is designed and verified to meet IEC 60601-1-8, edition 2.1. |
| Software Verification: Compliance with IEC 62304 for software lifecycle processes. | Software was verified according to a test protocol and underwritten as compliant with IEC 62304, Edition 1.1. |
| Usability: Device is usable, and AUTO mode operation is consistent with manual operation. | A Formative usability engineering study was completed. A Summative validation was completed that showed the subject device is usable and that the theory of operation of AUTO mode is consistent with the otherwise manual operation of a typical user in a typical use-case, compliant with IEC 62366-1. |
| Risk Management: Risk mitigations verified, residual risks assessed, and overall benefit-risk established (benefits outweigh risks). Compliance with ISO 14971. | Risk management was applied throughout the development process. Risk mitigations were verified, residual risks assessed, and an overall benefit-risk was established, demonstrating that benefits far outweigh risks, compliant with ISO 14971. |
| Temperature Probe Compatibility: Temperature from controller readout must be within 0.2°C of converted YSI-400 temperature for 34-41°C range, and within 0.5°C for 20-34°C and 41-45°C ranges. ("combination of these tolerances gives an acceptance criteria") | Additional bench testing showed that for each temperature entry, the criteria passed, demonstrating that the device is compatible with Augustine YSI-400 probes. The controller readout has a resolution of 0.1°C, and Augustine YSI-400 probes are interchangeable within 0.2°C for 34-41°C and within 0.5°C for 20-34°C and 41-45°C. |
| Warming Function: Comparable to predicate device. | Bench testing demonstrates that the device is substantially equivalent to the predicate device in warming function. Temperature characteristics and safety systems were assessed and found to be comparable. |
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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