(67 days)
The HTTP system is intended to prevent and treat Hypothermia and provide warmth to cold or shivering patients. In addition, the HTTP system should be used whenever conditions exist that could cause patients to become cold/hypothermic.
The HTTP system is indicated primarily for use in hospital, intensive care units, in operating, recovery and emergency rooms, in burns units and on medical/surgical floors. This system can be used with adults patients.
The HTTP 2001 Controller and HTTP "Warm me" Blankets ("HTTP System") are designed to compensate for body heat loss before, during and after surgery, especially cavity surgery, and to compensate for the decrease in intensity of all internal processes due to narcosis.
The system conducts direct heat to up to 4 blankets. HTTP Blankets are available in different shapes and sizes, including a modular kit of 4 blankets, e.g., one for each leg, the Full Chest, Half Chest, Back or Abdomen "Warm me" Blanket. The blankets are modular, pliable, disposable, insulated and isolated.
HTTP System is suitable for all patient sizes. Each blanket is connected to a separate heater. A single blanket uses a single heater. The complete set of blankets applies heat to all sections of the patient's body that are not involved in the surgery.
A computerized feedback loop controls patient core temperature in response to each patient's needs, as prescribed by the physician.
The electrical output from Controller to blankets is only 6V. The system is powered by mains or by batteries.
The provided text describes a 510(k) summary for the HTTP System, a thermal regulation device. However, it does not include information about acceptance criteria, a specific study proving the device meets those criteria, or the detailed study parameters requested in your prompt.
The document focuses on:
- Device identification: Name, submitter, classification, predicate devices.
- Intended use and indications for use.
- Device description: How it works (direct heat, modular blankets, computerized feedback for temperature control).
- Safety and Effectiveness: Mentions compliance with various electrical and electromagnetic standards (EN60601-1, EN60601-2-35, EN60601-1-2), software verification/validation, and biocompatibility testing for blankets. It vaguely states "The effective performance of the HTTP System has been established through in vitro and clinical studies" but provides no details on these studies or their results related to specific performance metrics.
- Substantial Equivalence: Compares its characteristics to predicate devices.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text, as the necessary details are simply not present.
Here's a breakdown of what cannot be answered and why:
- 1. Table of acceptance criteria and reported device performance: No specific acceptance criteria (e.g., target temperature range, heating rate, temperature uniformity) are mentioned, nor are any quantitative performance results provided from studies.
- 2. Sample size and data provenance for the test set: No details on any "test set" are given for performance evaluation.
- 3. Number and qualifications of experts for ground truth: Not applicable, as no ground truth establishment for a diagnostic or AI performance is mentioned.
- 4. Adjudication method for the test set: Not applicable.
- 5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No mention of such a study. This device is a therapeutic hypothermia/warming system, not an AI-assisted diagnostic tool for human readers.
- 6. Standalone (algorithm only) performance: The device has a "computerized feedback loop" but no specific "algorithm-only" performance metrics are provided. The "effective performance" is stated to be established through in vitro and clinical studies generally, not specifically for an algorithm's standalone operation.
- 7. Type of ground truth used: Not applicable in the context of diagnostic performance evaluation. The "effective performance" likely refers to its ability to maintain or change patient temperature, but the ground truth definition for this is not specified.
- 8. Sample size for the training set: No information is provided about a training set. While the device has a "computerized feedback loop," and presumably some internal control algorithm, the document does not describe it as an AI/ML system that undergoes a separate training phase with a distinct dataset for external validation.
- 9. How the ground truth for the training set was established: Not applicable, as no training set is described.
In summary, the provided 510(k) summary is for a medical device (a thermal regulation system) and focuses on its safety, general effectiveness, and substantial equivalence to predicate devices, rather than the detailed performance evaluation of an AI/ML algorithm or diagnostic tool.
§ 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).