(289 days)
The ChillBuster® Model 8001 Portable Electric Blanket System has been developed 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® Model 8001 Portable Electric Blanket System is made up of six major components: Blanket, Control Module, Battery, Cabling, AC Adapter, and Carrying Bag. The Blanket features a waterproof nylon outer layer, an inner layer of soft polar fleece, and a unique pattern of special thermal wire and a wire-adjacent thermistor. The Control Module contains an electronic circuit board, a User Interface Panel, Interconnect Wiring, and a Molded Chassis with a compartment for the Battery. The System uses a sealed lead acid, rechargeable Battery. Cabling includes a standard Blanket Interconnect Cable and an optional cable for connection to a vehicle cigarette lighter socket. All Systems include a standard AC-to-DC Adapter. The Carrying Bag conveys no impact on system safety.
The provided text does not contain acceptance criteria or study details for a medical device in the context of the requested information (AI/algorithm performance, ground truth, expert review, MRMC studies, etc.).
Instead, the document is a 510(k) summary for a "ChillBuster® Model 8001 Portable Electric Blanket System," which is a physical medical device, not a software algorithm or AI-based system.
Therefore, I cannot extract the information required to populate the table or answer the specific questions about AI/algorithm performance. The non-clinical performance data section describes tests conducted on the physical electric blanket, focusing on safety standards (IEC, UL), general operation, warming performance, and comparison to a predicate device in terms of heat output and distribution.
To directly address your request given the provided input:
1. Table of acceptance criteria and reported device performance:
The document does not explicitly state "acceptance criteria" for an algorithm. It describes safety standards and functional verification for a physical electric blanket, and "product specifications" were met.
| Acceptance Criteria (Not applicable for AI/Algorithm) | Reported Device Performance (Physical device - ChillBuster Model 8001) |
|---|---|
| NA | Met IEC 601-1 (1998; Amd. 1: 1991; Amd. 2; 1995) Safety Standard |
| NA | Met UL 2601-1 Safety Standard |
| NA | Met IEC 601-1-2 EMC Standard |
| NA | Generated distributed, low-level active heat throughout intended operating range |
| NA | Demonstrated progressive lengthening of functional blanket heat delivery as temperature setting varied from highest to lowest |
| NA | Met all product specifications under simulated in-use test conditions |
| NA | Compared favorably to predicate device (Life-Air 1000) in heat production and distribution (Model 8001 showed more even heat distribution while predicate had higher max output) |
| NA | Informal tests by >50 subjects reported rapid rise to moderate, comfortable temperature, then constant |
| NA | No adverse equipment or performance encountered in informal testing |
| NA | Maintained function after 10 machine wash/dry cycles without degradation of temperature rise time or heat delivery |
2. Sample size used for the test set and the data provenance: Not applicable for an AI/Algorithm test set. For the physical device, informal tests involved ">50 individuals" (independent subjects). The formal tests were conducted by Northwest EMC, Inc., an independent commercial firm. The data provenance is primarily from independent testing by Northwest EMC, Inc. and informal testing by ThermoGear™ in the US (Tigard, OR).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/algorithm is not discussed. For the physical device, compliance with standards and functional performance was assessed by an independent testing firm and informal user feedback.
4. Adjudication method for the test set: Not applicable.
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 document describes a physical electric blanket, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable for an AI/algorithm. For the physical device, "ground truth" was based on adherence to recognized safety and EMC standards (IEC 601-1, UL 2601-1, IEC 601-1-2) and the observed functional characteristics during testing (e.g., heat generation, battery life, washing performance).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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).