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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.

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The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.

The Bair Hugger temperature management system consists of a portable forced-air temperature management unit (series 500 or 700 units) and a disposable Bair Hugger forced-air blanket (various models).

This document is a 510(k) summary for a modified product labeling for the Bair Hugger Temperature Management System. It primarily focuses on regulatory approval based on substantial equivalence to previously cleared devices.

Therefore, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "The technological characteristics of the cleared devices do not change with this modification to product labeling." This indicates that no new performance studies were conducted or required, as the device's technical specifications and function remain the same. The submission is for modifying the product labeling, not for a new or significantly modified device requiring new performance evaluations.

As a result, I cannot provide the requested information from the given text.

To address your request, if this were a document detailing a new device or significant modification requiring performance studies, I would look for sections describing:

1. Performance data/clinical data: This would typically include tables of results, statistical analyses, and comparisons to established benchmarks or predicate devices.
2. Test methods: Descriptions of how the device was tested.
3. Ground truth establishment: How the "correct" answers or outcomes were determined for the study.
4. Sample sizes: The number of subjects or cases included in the study.
5. Expert qualifications and adjudication: If human evaluation was part of the ground truth or study design.

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The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient the comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperatur management system can be used with adult and pectratr patients.

The Bair Hugger temperature management system consists of:

• · a portable forced-air temperature management unit (200, 500, or 700 series),
• · a disposable Bair Hugger forced-air blanket (various models), and
• · the Model 459 patient cooling set (new disposable component of the system).

The temperature management unit delivers warmed or room-temperature air directly to a Bair Hugger blanket via a flexible hose, or it delivers room-temperature air to the Model 459 patient cooling set, which, when filled with common ice, cools the air before delivering it to a Bair Hugger blanket. Depending on the blanket model used, the blanket is placed around, over, or underneath the patient. Small perforations in the patient-side of the blanket disperse the air over the patient.

The new disposable Model 459 patient cooling set consists of an ice receptacle (flexible plastic bag) with an attached flexible hose assembly. The patient cooling set also has a handle to allow hanging it on an IV pole or similar stand near the temperature management unit.

The ice receptacle has:

• · a hose port that accepts the hose of a Bair Hugger® temperature management unit,
• · a resealable opening for adding and retaining ice,
• · a valve for draining meltwater, and
• · an integral divider that directs the flow of room-temperature air from the temperature management unit through the ice, which cools the air to a temperature ranging between 3.5℃ and room temperature, as required.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bair Hugger Model 459 Patient Cooling Set:

1. Table of Acceptance Criteria and Reported Device Performance:

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