(37 days)
The Norm-O-Temp® Model 111Z hyperthermia system is intended to prevent hypothermia during surgical procedures and to reduce cold discomfort before, during, and after a surgical procedure. The thermal regulating system is used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. The water heated blankets transfer the thermal energy to adult, pediatric, and infant (includes neonates) patients to keep a patient at a comfortable temperature. The Norm-O-Temp system is composed of a heater, circulating pump, and blankets/pads. It is intended for use by appropriately trained healthcare professionals in clinical environments.
The Cincinnati Sub-Zero Norm-O-Temp (Model 111Z) is a water re-circulating system providing either hyperthermia or normothermia treatment as determined by the health care provider. It is a total body hyperthermia system used to keep a patient comfortable by maintaining blanket/pad water temperature through conductive heat transfer. Water is heated and pumped from the device, through connecting flexible tubing, to disposable or reusable blankets/pads. The blankets/pads rest under, on top of and/or around the patient and are designed so that the water circulates through the blankets/pads and returns back to the device. The device is designed to operate based on the temperature of the circulating water. The system is used in Operating rooms, Post Anesthesia Care Units, Recovery rooms, Intensive Care Units, and Emergency Rooms with adult, pediatric and infant (including neonate) patients. The blankets/pads that are used with the Norm-O-Temp system are offered in a variety of sizes from large to small to meet the needs of the patients.
The Cincinnati Sub-Zero Norm-O-Temp® Model 111Z Hyperthermia System is a temperature management system designed to prevent hypothermia and reduce cold discomfort in patients during and after surgical procedures. The device operates by recirculating heated water through blankets/pads to transfer thermal energy to the patient via conductive heat transfer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Temperature Performance per ASTM F-2196 (Standard Test Method for Measuring Performance of Thermal Regulating Systems for Patient Warming and Cooling) | The device successfully passed Temperature Performance Testing as per ASTM F-2196. This indicates the Norm-O-Temp system can accurately achieve and maintain the desired water temperature within its blankets/pads for effective patient warming. |
| System Safety Limits per ASTM F-2196 | The device successfully passed System Safety Limit Testing as per ASTM F-2196. This suggests the device operates within defined safety parameters, preventing overheating or other dangerous conditions for the patient and user. |
| Transportation Testing | The device successfully passed Transportation Testing. This indicates the device can withstand the rigors of shipping and handling without compromising its functionality or safety. |
| IEC 60601-1 (Second Edition) General Requirements for Safety (including Amendments 1 and 2) | The new system meets the applicable requirements of IEC 60601-1 (Second Edition), indicating it adheres to international standards for electrical medical equipment safety. |
| IEC 60601-1-2:2007 (Third Edition) Electromagnetic Compatibility | The new system meets the applicable requirements of IEC 60601-1-2:2007 (Third Edition), indicating it is electromagnetically compatible with other devices and does not cause or succumb to excessive electromagnetic interference. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes bench testing. For bench testing, the "sample size" refers to the number of devices or components tested. The document does not explicitly state the number of Norm-O-Temp Model 111Z Hyperthermia Systems that underwent the listed tests.
The data provenance is from bench laboratory testing, likely conducted by the manufacturer, Cincinnati Sub-Zero Products, Inc. The testing is for design validation and to demonstrate substantial equivalence, indicating it is prospective testing for a new device. There is no information regarding the country of origin of the data beyond the manufacturer's location in Cincinnati, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of study conducted. Bench testing for a medical device like a hyperthermia system does not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI algorithms do. Instead, the "ground truth" or acceptance criteria are derived from established industry standards (e.g., ASTM, IEC) and the device's design specifications. The performance is measured against these objective standards.
4. Adjudication Method for the Test Set:
This information is not applicable. Since the testing involves objective measurements against established technical standards, there is no need for human adjudication of results in the traditional sense of a clinical or image-based study. Device performance either meets the objective criteria or it does not.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical data (e.g., radiologists reading images) and the impact of AI assistance on that interpretation. The Norm-O-Temp system is a therapeutic device, and its effectiveness is assessed through its physical performance and safety features, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This concept is not applicable to the Norm-O-Temp Model 111Z Hyperthermia System in the way it is used for AI-powered diagnostic algorithms. The device itself is a standalone medical device that performs its function (heating water and circulating it) without an "algorithm" in the AI sense that would require human-in-the-loop interaction for interpretation or decision-making. Its performance is measured directly through its physical outputs (temperature, safety limits).
7. Type of Ground Truth Used:
The "ground truth" for this study is based on objective technical specifications and established industry standards. Specifically:
- ASTM F-2196: Standard Test Method for Measuring Performance of Thermal Regulating Systems for Patient Warming and Cooling. This standard defines how to measure temperature performance and safety limits.
- IEC 60601-1 and IEC 60601-1-2: International standards for the safety and electromagnetic compatibility of medical electrical equipment.
- Company's specified design requirements: The manufacturer's internal criteria for the device's functionality and safety.
8. Sample Size for the Training Set:
This information is not applicable. The Norm-O-Temp Model 111Z is a physical medical device, not an AI model that requires a "training set" of data for machine learning. Its operation is based on hardware and software logic, not statistical learning from data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable, as there is no "training set" in the context of this device. The device's functionality is designed and engineered according to specifications and validated through testing against those specifications and relevant standards.
§ 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).