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The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use:

· In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care. (Maximum use period = 4 days)

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days)

· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarcerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period = 7 days)

The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating.

The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.

Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

The document provided describes the Solex 7™ Intravascular Heat Exchange Catheter and Start-Up Kit and its substantial equivalence to predicate devices, based on nonclinical testing. This is a 510(k) premarket notification, which demonstrates a device is at least as safe and effective as a legally marketed predicate device, rather than proving effectiveness through clinical trials required for a PMA.

Therefore, the study described here is primarily a set of nonclinical tests to show that the modified device performs similarly to its predicate devices and meets its own design specifications.

Here's an analysis of the acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:

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

The document provides multiple tables (Table 3, Table 4, Table 5, Table 6, Table 7) detailing various tests, their methods, and results. These tables effectively serve as the acceptance criteria and reported device performance. I will consolidate key examples below.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document generally refers to "samples" or "catheter samples" without specifying precise numerical sample sizes for most bench tests. However, for "Particulate Testing," it mentions "Solex 7 samples and Cool Line samples."

• Sample Size: Not explicitly stated numerically for most tests. It refers to "catheter samples," "SUK systems," "all samples," etc.
• Data Provenance: This is a nonclinical study conducted by ZOLL Circulation, Inc. (submitter). The tests are laboratory-based and simulated, rather than involving human subjects or real-world clinical data. Therefore, concepts like country of origin for data or retrospective/prospective don't directly apply in the same way they would for a clinical study. The tests were performed to verify performance against international standards (ISO, EN ISO, ASTM, USP).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable (N/A). The "ground truth" for these tests is defined by established engineering and medical device standards (e.g., ISO, ASTM, USP criteria for tensile strength, leakage, biocompatibility, etc.) and the device's own design specifications. Expert consensus in the traditional sense (like for medical image interpretation) is not directly involved in setting the pass/fail criteria for these bench tests. The human factors testing involved "users" but not experts establishing ground truth for objective performance metrics in the same way.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where subjective expert review is required (e.g., for ambiguous medical findings). For these nonclinical bench tests, results are typically objective measurements or observations against predefined pass/fail criteria outlined in the test methods.

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

This section is N/A. The document describes a medical device (intravascular heat exchange catheter and start-up kit), not an AI diagnostic or assistance system. Therefore, an MRMC comparative effectiveness study or assessment of human reader improvement with AI assistance is not relevant.

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

This section is N/A. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" for this device's performance is based on a combination of:

• International Standards: ISO 10555-1, ISO 594-1, ISO 594-2, EN ISO 10555-1, USP <788>, ASTM Hemolysis standards.
• Device Design Specifications: Specific dimensional tolerances, flow rates, heat exchange power, tensile strength, burst/leak resistance, indwell life, and biocompatibility criteria defined by the manufacturer for the device.
• Human Factors Test Scenarios: User tasks designed to assess the ease and correctness of device usage as per the Instructions for Use (IFU).

8. The sample size for the training set

This section is N/A. This is not a machine learning or AI device, so there is no "training set" in the context of algorithm development.

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

This section is N/A for the same reason as above.

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