(29 days)
The Bair Hugger temperature management system is intended to prevent and treat hypothermia. In addition the temperature management system can be used to provide patient thermal comfort when continuations 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 3MM Bair Hugger™ Temperature Management System, Model 675 consists of a Model 675 portable warming unit (with optional rolling cart) along with a 3M Bair Hugger warming blanket or warming gown. The Bair Hugger warming unit provides forced warm air using an electrical resistance heater, fan/blower and a user control interface. Warmed air flows from the warming unit into a Bair Hugger warming blanket or warming gown by means of a flexible connecting hose. The Bair Hugger warming blanket or warming gown is placed over, around or underneath the patient. Small perforations in the blanket or gown allows the forced warm air to be gently dispersed over a patient's skin to prevent and treat hypothermia, and/or to provide patient thermal comfort. The warming unit may be controlled to provide only ambient (non-warmed) air.
The provided text is a 510(k) summary for the 3M™ Bair Hugger™ Temperature Management System, Model 675. This document discusses the substantial equivalence of the new device to a predicate device (also Model 675, K171373), focusing on design, energy source, warming performance, and safety.
However, the provided text does not contain any information about acceptance criteria or a study that specifically addresses a device's performance against such criteria for AI/ML algorithms.
Here's why the information you're asking for isn't present in the text:
- Device Type: The 3M™ Bair Hugger™ Temperature Management System is a medical device for patient warming, not an AI/ML powered diagnostic or therapeutic device. The questions you've posed (sample size, experts, ground truth, MRMC, standalone performance) are highly specific to the validation of AI/ML algorithms, particularly in medical imaging or similar data-driven fields.
- 510(k) Focus: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics, intended use, and performs as safely and effectively as the predicate, typically through non-clinical testing (like adherence to IEC standards for heating devices) and sometimes clinical data if there are significant changes. It doesn't typically involve the type of AI/ML validation studies described in your request.
- "Additional software upgrades" are mentioned: While software upgrades are noted, the document doesn't detail what these upgrades are, whether they involve AI/ML, or how they were validated beyond implied safety and performance equivalence to the predicate.
Therefore, I cannot populate the table or answer the specific questions below based on the provided text. The text pertains to a different type of medical device submission and validation process.
If you have a document describing the validation of an AI/ML medical device, please provide that, and I would be happy to help.
§ 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).