(30 days)
The Solex 7 Intravascular Heat Exchange Catheter connected to the CoolgardThermal Requlation 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 patients in surgery and recoverylintensive care. (Maximum use period: 4 days)
- · In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infaction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)
The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:
- · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurqery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
- · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recoverylintensive care, and
- · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (either the Thermogard HQ™ Console or the Thermogard XP® Console) and intravascular heat exchange catheters connected via a sterile heat exchanger and tubing circuit. These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the Thermogard HQ™ Console (TGHQ) and the Thermogard XP® Console (TGXP) for software changes due to the addition of the TrakLo functionality to both consoles.
Here's a breakdown of the requested information based on the provided text, regarding the "TrakLo" feature of the Thermogard XP Console and Thermogard HQ Console:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Human Factors / Usability | Passed - "Test methods validate the device for human factors per the intended use with the TrakLo feature." |
| Software Verification | Passed - "Test methods verify that the software meets software requirements." |
| Device operates as intended | Passed - "The Thermogard HQ™ Console and Thermogard XP® Console with the TrakLo feature meet the design, performance, and safety specifications when used in accordance with the labeling." and "The difference between the subject and predicate devices does not raise new questions of safety and effectiveness." |
| Substantial Equivalence | Achieved - "It was demonstrated through performance testing and comparison of design features that the proposed devices are substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the test set for the TrakLo feature's non-clinical testing. It only states "Test methods validate the device for human factors per the intended use with the TrakLo feature" and "Test methods verify that the software meets software requirements." This suggests internal testing without a specified sample size for "human factors" or "software verification" in the context of clinical trials.
The data provenance for the non-clinical testing is implied to be internal testing conducted by ZOLL Circulation, Inc. The document does not mention details about country of origin or whether it was retrospective or prospective data in the context of this specific regulatory submission for the TrakLo feature.
It is important to note that the broader warnings regarding the "Cool Line Intravascular Heat Exchange Catheter" refer to a randomized controlled trial of 296 patients, but this clinical trial data is not related to the TrakLo feature, but rather to the initial clearance of the Cool Line device and its limitations for certain fever reduction indications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about the number or qualifications of experts used to establish ground truth for the non-clinical tests (Human Factors/Usability and Software Verification) related to the TrakLo feature.
4. Adjudication method for the test set
The document does not describe any adjudication method for the test set. For software and human factors testing, "adjudication" in the sense of expert consensus on clinical outcomes is typically not applicable. The testing would have followed internal protocols to assess functionality and usability.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for the TrakLo feature. The TrakLo feature is a software enhancement to an existing thermal regulation console, primarily affecting alarm behavior, not an AI-assisted diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance of the TrakLo feature itself, as a software algorithm, was evaluated in standalone non-clinical testing. The "Software Verification" and aspects of "Human Factors / Usability" tests evaluate the algorithm's functionality and its interaction with the user interface, independent of a clinical human-in-the-loop scenario for diagnostic purposes. It's a control algorithm enhancement, not an AI for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the TrakLo feature:
- Software Verification: The ground truth would be the defined software requirements and specifications. The tests verify that the code implements these requirements correctly.
- Human Factors / Usability: The ground truth would involve established human factors engineering principles and usability goals, likely assessed through user observation, task analysis, and error analysis against predetermined acceptance criteria related to usability.
8. The sample size for the training set
This information is not provided. The TrakLo feature is described as a software modification for improved utility in warming applications, preventing a "Lo alarm" under specific conditions. It doesn't appear to be an AI/machine learning model that would require a distinct "training set" in the conventional sense. It's an algorithmic change.
9. How the ground truth for the training set was established
As described above, the concept of a "training set" and associated "ground truth" for training an AI model does not apply here based on the information provided. The TrakLo feature is an algorithmic change for alarm management under specific temperature conditions.
§ 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).