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510(k) Data Aggregation
(90 days)
HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
The Hot Dog Patient Warming Mattress System is intended to prevent or treat hypothermia and to provide warmth to patients. The Hot Dog Patient Warming Mattress should be used in circumstances in which patients may not maintain a state of normothermia. The mattress includes a pressure relieving pad.
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 Patient Warming Mattress System consists of a temperature control unit that monitors and controls the temperature of a patient warming mattress. The mattress is composed of a conductive polymer coated fabric heater encased in a polymer shell. The mattress also contains a pressure relieving foam pad.
It looks like the text provided is a 510(k) Premarket Notification summary for a medical device called the "Hot Dog Patient Warming Mattress System." This type of document is for regulatory clearance by the FDA, demonstrating substantial equivalence to existing devices, rather than a clinical study proving performance against acceptance criteria in the way a new drug or high-risk device might.
Here's an analysis based on the provided text, addressing the points you requested:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the "acceptance criteria" are not reported as specific numerical targets for performance metrics (e.g., "device must maintain temperature within +/- 0.5°C for 95% of use"). Instead, the acceptance criteria are framed in terms of meeting established medical device performance standards and being "comparable" or "substantially equivalent" to predicate devices.
| Acceptance Criteria (Standards/Comparisons) | Reported Device Performance |
|---|---|
| IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-1-4:2000, Medical electrical equipment - Part 1: General requirements for safety - 4 - Collateral standard: Programmable electrical medical systems | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| IEC 60601-2-35 Particular requirements for the safety of blankets, pad and mattresses intended for heating in medical use | The mattress system is designed to meet this standard. (Implied compliance through design and testing). |
| Comparison to Predicate Devices (Inditherm Patient Warming System - K051419, Hot Dog Patient Warming System - K052392, Bair Hugger Patient Warming System Model 505 - K960167, Bair Hugger Patient Warming System Model 750 - K001149) - in terms of: - Technological characteristics - Indications for Use - Design - Materials - Components - Dimensions - Temperature characteristics - Pressure relief characteristics - Safety systems | "A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent." "The products have similar designs, materials, components and dimensions." "Bench testing was performed to demonstrate that the proposed warming mattress system is substantially equivalent to the predicate devices. Temperature characteristics, pressure relief characteristics and safety systems were compared and found to be comparable." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of human subject data for performance evaluation. It mentions "Bench testing" which implies laboratory or engineering tests. There is no information provided about sample sizes for this testing or data provenance (e.g., country of origin, retrospective/prospective), as it was likely internal engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The evaluation presented is based on engineering principles, compliance with technical standards, and comparison to predicate devices, not on expert consensus from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. There was no clinical test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The "Hot Dog Patient Warming Mattress System" is a therapeutic device, not an imaging device.
6. Standalone Performance
The "Bench testing" performed demonstrates standalone performance of the device against technical standards and in comparison to predicate devices. The summary states: "Bench testing was performed to demonstrate that the proposed warming mattress system is substantially equivalent to the predicate devices. Temperature characteristics, pressure relief characteristics and safety systems were compared and found to be comparable." However, specific numerical metrics of standalone performance are not detailed in this summary.
7. Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is based on:
- Compliance with recognized industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-35.
- Engineering specifications and design comparisons to legally marketed predicate devices.
- Bench test results (presumably against internal specifications and predicate device performance).
There is no mention of pathology, outcomes data, or expert consensus from clinical evaluation as ground truth.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device described (a patient warming mattress) is not an AI/ML device that requires a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for an AI/ML algorithm.
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