(233 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 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.
| Acceptance Criteria (Compliance with Standards/Characteristics) | Reported Device Performance (Demonstrated through Bench Testing) |
|---|---|
| Electrical safety and electromagnetic compatibility (EMC): | The device is designed and verified to meet the following performance standards: |
| - ANSI AAMI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, A1:2012, C1:2009/(R)2012 (FDA recognition #19-4) | Compliant |
| - IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 4.0 (FDA recognition # 19-8) | Compliant |
| Particular Standards for Warming Mattresses and Electrosurgery: | The device is designed and verified to meet the following particular standards: |
| - IEC 80601-2-35, Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use, edition: 2.1 (FDA recognition # 6-390) | Compliant |
| - IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, edition 6.0 (FDA recognition # 6-389) | Compliant |
| Risk Management: | Risk management was applied, risks related to use with two ESUs were analyzed, mitigations verified, and residual risks assessed. Overall benefit-risk was established. |
| - ISO 14971, Medical Device - Application of Risk Analysis to Medical Devices, third edition (FDA recognition # 5-125) | Compliant (Benefits outweigh risks) |
| Human Factors & Usability Engineering: | Applied to the device design and throughout risk management. |
| - IEC 62366-1, Medical Device - Application of usability engineering to medical devices, Edition: 1.0 (FDA recognition # 5-114) | Compliant |
| Performance with one vs. two ESUs: | Demonstrated substantial equivalence to the predicate device. |
| - Temperature rise performance | Substantially equivalent to predicate (when utilizing two or one ESUs, supported by reference device methodology). |
| - Impedance | Theoretically unaffected by one or two generators; no additional bench testing deemed necessary. |
| - Patient Leakage | Conducted under worst-case conditions; demonstrated safety in dual generator use. |
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.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).