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510(k) Data Aggregation
(87 days)
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
The Arctic Sun Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature.
The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 32°C to 38.5 C (89.6°F to 101.3 F). The Arctic Sun System consists of the Arctic Sun Control Module and disposable ArcticGel Pads.
A patient temperature probe connected to the Control Module provides patient temperature feedback to an internal control algorithm which automatically increases or decreases the circulating water temperature to achieve a pre-set patient target temperature determined by the clinician.
The Arctic Sun pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through the ArcticGel Pads, resulting in heat exchange between the water and the patient.
Here's an analysis of the provided text regarding the Arctic Sun™ Temperature Management System, Model 5000, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific pass/fail acceptance criteria in a quantitative format (e.g., "accuracy ±X°C"). However, it broadly describes the testing performed and the conclusion drawn.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New features functional as designed: New GUI, touch screen, streamlined industrial design, associated software modifications. | "The verification and validation test results demonstrate that the new control panel graphic user interface functions as designed." "The Arctic Sun Model 5000 is safe and effective for its intended use." |
| Performance equivalent to predicate device: Meeting and controlling patient temperature within 32°C to 38.5°C. Water temperature ranging between 4°C and 42°C. | "Full system software, performance, functional, and inspection verifications were performed on the Arctic Sun Model 5000." "Design verification of the system requirements and software validation of the control and monitor processors software requirements involved repeating the same or similar testing conducted on the predicate Arctic Sun Model 2000." |
| No new safety or effectiveness issues. | "Based upon the testing and comparison to the predicate device, the Arctic Sun Temperature Management System performs as intended and raises no new safety or effectiveness issues." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test set. It mentions "Full system software, performance, functional, and inspection verifications" and "Design verification of the system requirements and software validation of the control and monitor processors software requirements."
The data provenance is for a medical device submitted to the US FDA for 510(k) clearance, implying the testing was prospective as part of the device's development and regulatory submission. The country of origin for the data is not explicitly stated but is implicitly related to Medivance, Inc. in Louisville, Colorado, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described appears to be primarily engineering and software verification/validation, not a clinical study involving human expert judgment for "ground truth."
4. Adjudication Method for the Test Set
This information is not provided as the type of testing described (engineering/software verification) does not typically involve an adjudication method in the way a clinical study would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission is for a thermal regulating system, and the testing described focuses on the functionality and safety of the device itself, particularly changes to the user interface and software, rather than evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, effectively, a standalone performance evaluation was done. The "control algorithm" mentioned in the device description operates automatically based on patient temperature feedback. The "software validation of the control and monitor processors software requirements" would be an evaluation of this algorithm's performance in achieving and maintaining target temperatures without direct human intervention in the temperature regulation process itself.
7. Type of Ground Truth Used
For the performance aspects (monitoring and controlling temperature), the ground truth would be objective physical measurements (e.g., calibrated temperature sensors) rather than expert consensus, pathology, or outcomes data. For the software and user interface, the ground truth would be adherence to design specifications and functional requirements.
8. Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. While the device utilizes a "control algorithm," the documentation does not indicate that this algorithm was developed using machine learning with a distinct training set. It's more likely a rule-based or PID (Proportional-Integral-Derivative) control system that doesn't traditionally have a "training set" in the sense of supervised learning. Therefore, this information is not applicable/provided.
9. How the Ground Truth for the Training Set Was Established
As explained above, a "training set" with established ground truth is not mentioned or implied for this device's control algorithm. The ground truth for developing and validating such a system typically comes from engineering principles, mathematical modeling, and previous predicate device data.
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