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The Hybrid ArcticGel™ Pad is indicated as a standalone cooling device for the reduction of core temperature of adult patients where clinically indicated (e.g. heat stroke or hyperthermia). Additionally, the Hybrid ActicGel™ Pad is indicated as an adjunct to patient temperature control with the Arctic Sun® Temperature Management System. The Hybrid ArcticGel™ Pad is intended for use by health care professionals in all clinical environments, including, but not limited to in- hospital as well as EMS/transport settings.

The Arctic Sun Hybrid ArcticGel Pads are a modified version of the Arctic Sun ArcticGel Pads. The Hybrid ArcticGel Pad is designed to operate in two different modes, Ice Gel Mode in which is the pre-frozen pads are used as standalone devices to initiate patient cooling, and Water Flow Mode in which the pads are connected to the Arctic Sun Temperature Management System which is used to control the patient at a target temperature. These dual modes provide the opportunity for early initiation of cooling in the pre-hospital setting or the hospital emergency department followed by continued temperature management with the Arctic Sun once the ice gel is thawed. The Hybrid ArcticGel Pads are pre-frozen in a freezer operating between -3°C and -20°C (27°F and -4°F). The release liners are removed from the hydrogel adhesive, and the frozen Hybrid ArcticGel Pads are applied to the patient's skin. Between 4 and 8 pads are applied to the patient, depending on the patient's size and patient temperature reduction required. Heat from the patient is conducted through the hydrogel and pad layers into the ice gel compartment. The heat from the skin melts the ice gel. The duration of Ice Gel Mode is approximately 60 to 90 minutes from the time of application to complete melting of the Ice Gel. To convert to Water Flow Mode, pad lines are irreversibly snapped onto the inlet and outlet water ports of the Hybrid ArcticGel Pads. The pad line connectors are connected to the Arctic Sun fluid delivery line. Up to 6 Hybrid ArcticGel Pads may be connected to the Arctic Sun. Temperature controlled water from the Arctic Sun control module can then be circulated through the pad. The water passes through the water flow compartment, allowing heat to be transferred from the patient's skin across the hydrogel adhesive and into the circulating water.

The provided text describes a 510(k) summary for the Medivance Arctic Sun Hybrid ArcticGel Pad. It details the device, its intended use, and its substantial equivalence to predicate devices, supported by testing. However, it does not explicitly define acceptance criteria or detail a specific study proving the device meets those criteria in the typical sense of a clinical trial with statistical endpoints for performance.

Instead, the document focuses on comparative performance testing to demonstrate substantial equivalence to predicate devices and safety testing.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in the format of a table with thresholds and measured performance. However, based on the Testing section, the implicit acceptance criteria are:

2. Sample size used for the test set and the data provenance

• Biocompatibility Testing: The sample size for biocompatibility testing is not specified, nor is the data provenance.
• Comparative Performance Testing: The sample size for comparative performance testing is not specified, nor is the data provenance.
• Safety Tests (Porcine Skin Model): The sample size for the porcine skin model is not specified (e.g., number of pigs or number of pads tested). The provenance is an animal model, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for any of the described tests. The tests appear to be primarily objective measurements (e.g., temperature, biocompatibility assays) rather than subjective expert evaluations.

4. Adjudication method for the test set

Not applicable, as no expert adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device, not an AI or imaging diagnostic tool that would typically involve human readers for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a passive cooling device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Biocompatibility: Ground truth would be based on established international standards (ISO 10993-05 and 10993-10) for cytotoxicity, irritation, and sensitization, likely using laboratory assays.
• Comparative Performance: Ground truth for "substantially equivalent cooling and temperature control performance" would be based on direct measurement of cooling rates and temperature stability as compared to the predicate devices. The specific metrics are not detailed but would be quantifiable.
• Safety (Porcine Skin Model): Ground truth for skin temperature would be direct temperature measurements, and "well-tolerated" would be based on observation for adverse reactions in the animal model.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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