(85 days)
ChillBuster™ Portable Electric Blanket is to be used to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition.
The ChillBuster™ Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Cabling, Battery, AC adapter, Carrying Bag.
This document appears to be a 510(k) Pre-market Notification Summary for a medical device called the "ChillBuster™ Portable Electric Blanket." It primarily serves to establish substantial equivalence to a legally marketed predicate device, rather than providing extensive details about a study demonstrating performance against specific acceptance criteria.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided in this type of submission.
Here's the breakdown based on the provided text, indicating where information is present versus where it's absent or not relevant for this document type:
Acceptance Criteria and Device Performance Study Details (K022903)
This 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards, rather than presenting a performance study with explicit acceptance criteria. The "acceptance criteria" here implicitly refer to meeting the requirements of the standards listed and performing equivalently to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied from Standards & Predicate Equivalence) | Reported Device Performance (Summary from 510k) |
|---|---|
| Safety: | Compliance: |
| • IEC 601-1: 1998; Amd. 1: 1991; Amd. 2: 1995 (General Medical Safety) | Unit was tested using these standards. |
| • UL 2601-1 (General Medical Safety) | Unit was tested using these standards. |
| Electromagnetic Compatibility (EMC): | Compliance: |
| • IEC 601-1-2 | Unit was tested using this standard. |
| Functional Equivalence: | Substantial Equivalence: |
| • Perform equivalently to ChillBuster™ (ThermoGear K991684) | Stated as substantially equivalent. |
| • Perform equivalently to Life-Air 1000 (Progressive Dynamics Inc.) | Stated as substantially equivalent. |
| Intended Use: | Met: |
| • Reduce effects of hypothermia during surgical procedures or other medical crises. | Indications for Use statement confirms this. |
| Device Characteristics: | Description Provided: |
| • Blanket size, materials, thermal wire array, control module components, battery, AC adapter, carrying bag. | Detailed component descriptions provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This document does not detail a specific performance study with a test set of data points or patients. The testing referenced is related to compliance with electrical and safety standards for the device itself, not a clinical data set.
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):
- Not applicable / Not provided. No ground truth establishment for a test set is discussed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No test set or related adjudication method is mentioned.
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 is a portable electric blanket, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No ground truth for a performance study is mentioned. The "ground truth" for this submission is implicitly the established safety and performance benchmarks of the predicate devices and the requirements of the cited industry standards.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/algorithm device, so there is no training set in the typical sense.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. (See #8).
§ 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).