(80 days)
The PRN ThermalCare patient warming system is intended to aid in the maintenance of patient normal thermia (maintaining normal body temperature of 36C) before, during and after the perioperative experience (surgery) for Pediatric and Adult patients. Conductive warming temperatures for the patient are selected by physicians (anesthesiologist or nurse anesthetist) or according to facility hypothermia protocol. Pressure reduction is achieved within the pad design. The pressure reducing properties are effective for Patients up to 500 1bs./225k
The PRN ThermalCare patient warming system, Model 3000 system includes a pressure reducing, thermal regulated mattress, which is placed beneath the patient, and a separate control unit. The mattress contains a carbon fiber heating element for which the control unit, when connected, supplies low voltage DC current, providing low level conductive heat (preset between 36°C and 40°C) to the patient.
The provided document is a 510(k) premarket notification for the PRN ThermalCare Patient Warming System Model 3000. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a clinical trial for a diagnostic AI device would.
However, I can extract the information related to safety and effectiveness testing as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are implicitly defined by compliance with recognized safety standards and acceptable operational integrity, as demonstrated by internal testing. The device's "performance" is stated as meeting these parameters.
| Acceptance Criteria (Implicit from Compliance) | Reported Device Performance |
|---|---|
| UL 2601-1 Safety Standard Compliance | Met requirements |
| CSA C22.2 No. 60601-1 Safety Standard Compliance | Met requirements |
| IEC 60601-2-35 Safety Standard Compliance | Met requirements |
| Operational Integrity Parameters | Met performance parameters |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of an analytical study with a specific number of instances. The testing described is related to device safety and operational integrity/performance, not a comparative efficacy study with human or AI readers. Therefore, information on sample size and data provenance (country, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The concept of "ground truth" and "experts" to establish it is typically relevant for diagnostic or AI-driven devices where human assessment is the reference. For this patient warming system, which is a therapeutic device, these elements are not applicable. The "ground truth" for safety and performance is based on adherence to engineering and medical device standards.
4. Adjudication Method
Since there is no "test set" or diagnostic assessment involving human experts, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is designed for diagnostic tools, particularly those involving image interpretation by multiple human readers, often with or without AI assistance. This type of study is not applicable to a patient warming system.
6. Standalone Performance Study
The document mentions "operational integrity testing," which demonstrates the device's standalone performance in meeting specified parameters. However, it does not provide quantitative results or a detailed study design typically associated with standalone performance reports for AI algorithms. It states: "The operational integrity testing conducted, demonstrated the device met the performance/effectiveness parameters."
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness is established by compliance with recognized electrical and medical device safety standards (UL 2601-1, CSA C22.2 No. 60601-1, IEC 60601-2-35) and demonstrated operational integrity against pre-defined performance parameters through internal testing. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be.
8. Sample Size for the Training Set
The concept of a "training set" with a specific sample size is relevant for machine learning or AI models. This device is a hardware-based patient warming system, not an AI or software algorithm in the sense that would require a training set. Therefore, information on a training set sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for the type of device described, how its "ground truth" was established is 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).