(154 days)
The Hot Dog Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Multifunction Controller should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.
The Hot Dog Multifunction Controller consists of a temperature control unit that monitors and controls the temperature of patient warming blankets and mattresses.
The provided text describes a medical device, the "Hot Dog Multifunction Controller," and its premarket 510(k) summary for FDA clearance. However, the document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or the details of such a study as requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).
The non-clinical data section states:
"Bench testing was performed to demonstrate that the proposed controller is substantially equivalent to the predicate devices. Temperature characteristics and safety systems were compared and found to be comparable."
"The controller is designed to meet the following performance standards:
- IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance, edition: 2
- IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, edition: 2.1
- IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems, edition 1.1."
The clinical data section simply states: "Not required."
Therefore, based solely on the provided text, I can only provide the following, which aligns with the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 (General Safety & Essential Performance) | Bench testing demonstrated substantial equivalence to predicate devices; temperature characteristics and safety systems were comparable. Designed to meet this standard. |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Designed to meet this standard. |
| IEC 60601-1-4 (Programmable Electrical Medical Systems) | Designed to meet this standard. |
| Substantial Equivalence to Predicate Devices (K052392, K092807) | Bench testing found the proposed controller to be substantially equivalent in technological characteristics, safety, and indications for use. |
| Temperature characteristics comparable to predicate devices | Bench testing showed comparable temperature characteristics. |
| Safety systems comparable to predicate devices | Bench testing showed comparable safety systems. |
2. Sample size used for the test set and the data provenance:
Not explicitly stated in the provided text. The document only mentions "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical or expert-reviewed ground truth study is described. The performance assessment relied on technical bench testing against predicate devices and adherence to international standards.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Data: Not required," indicating that studies involving human readers or clinical outcomes were not part of this 510(k) submission for the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a "Multifunction Controller" for a "Thermal Regulating System," not an algorithm in the typical sense of AI/image analysis. Its performance was assessed via "bench testing" focusing on its technical functions (temperature control, safety systems) against established standards and predicate devices.
7. The type of ground truth used:
For the technical performance, the "ground truth" was established by adherence to international performance standards (IEC 60601-1 series) and comparison to the characteristics of legally marketed predicate devices.
8. The sample size for the training set:
Not applicable, as this is not an AI/ML device that requires a training set.
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).