(161 days)
The WarmAir® 135 patient warming system is intended to prevent hypothermia and/or reduce cold discomfort before, during, and after surgical procedures. The thermal regulating system is used to raise a patient's temperature and/or maintain a desired patient temperature through convective heat transfer from the controller to a warm-air-heated blanket. The single-patient use blankets transfer the thermal energy to adult, pediatric or neonate patients to obtain/maintain normal body temperature. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The WarmAir 135 Hyperthermia System is a patient temperature management device which provides forced air warmed by the controller to a blanket that is placed over or under adult, pediatric or neonatal patients in order to warm them. The heated air is blown through connecting flexible hose to a disposable blanket to provide patient therapy by the means of warmed air.
Here's a breakdown of the requested information based on the provided 510(k) summary for the WarmAir® Model 135 Hyperthermia System:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., a target temperature range with a tolerance) and corresponding reported performance metrics in a clear, quantitative table for objective performance. Instead, it describes various bench tests performed to validate the design against "company's specified design requirements" and to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance (as described) |
|---|---|
| Temperature Performance Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." The primary and secondary safety shutdown set points have changed from the prior model. |
| System Safety Limit Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." The new Model 135 uses a thermistor for primary temperature safety and a snap disc thermostat for secondary temperature safety. |
| Transportation Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." |
| Blanket Structural Integrity Testing | Bench testing was performed to "validate the design according to the company's specified design requirements." |
| Safety Standards Adherence | Meets applicable requirements of IEC 60601-1 and IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench tests and adherence to standards, not a clinical study on patient data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" as they relate to patient data or imagery are not applicable here. The testing was conducted on the device itself, likely in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This was bench testing of a hardware device. Ground truth as typically understood for AI/diagnostic devices (e.g., expert consensus on medical images) does not apply.
4. Adjudication Method for the Test Set
Not applicable. This was bench testing.
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 is a hardware device for temperature management, not an AI or diagnostic software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware device.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would have been the engineering specifications and performance requirements defined by Cincinnati Sub-Zero, Inc. These are physical and measurable properties, not medical ground truth like pathology or expert consensus. For example, for "Temperature Performance Testing," the ground truth would be the expected temperature output and stability under various conditions, measured by calibrated instruments. For "System Safety Limit Testing," the ground truth would be the defined trip points for the safety mechanisms.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a hardware device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
§ 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).