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510(k) Data Aggregation
(185 days)
CELSIUS CONTROL SYSTEM
The Celsius Control™ System is a thermal regulating system intended to induce, maintain and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care, to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/ intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who required access to the central venous circulation and who are intubated and sedated.
The subject device is a thermal regulating system consisting of three (3) parts:
- an endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which is available in various diameters from 9 french to 14 french;
- a console containing refrigeration/heating elements, a heat exchanger to cool and warm the circulating fluid, a pump to circulate that fluid, and controls and software necessary to operate the system; and
- a sterile tubing set to connect the console to the catheter, and through which the thermal transfer fluid is circulated.
Two (2) models of the System are available: One which uses conventional, off-the-shelf thermistor probes such as YSI-400 esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
The provided text is a 510(k) Summary for the INNERCOOL therapies, Inc. Celsius Control™ System. It describes the device, its intended use, and comparison to predicate devices, but it does not contain information about specific acceptance criteria, device performance testing results, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. Therefore, I am unable to fill out the requested table and answer the questions based solely on the provided text.
The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing the specifics of performance studies against defined acceptance criteria.
Information NOT Found in the Document:
- A table of acceptance criteria and the reported device performance: Not present. The document states "The subject device has equivalent performance in inducing and reversing hypothermia, and in maintaining normothermia," but it doesn't provide specific quantitative acceptance criteria or reported performance metrics.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
- 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 present. This device is a thermal regulating system, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. This device is a physical therapeutic system, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of this device's type of evaluation as described. Performance for a thermal regulating system would typically involve physiological measurements in subjects or bench testing.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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(189 days)
CELSIUS CONTROL SYSTEM
The Celsius Control™ System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.
The subject device is a thermal regulating system consisting of three (3) parts:
- . an endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which is available in various diameters from 9 french to 14 french;
- a console containing refrigeration/heating elements, a heat exchanger .
- to cool and warm the circulating fluid, a pump to circulate that fluid, and controls and software necessary to operate the system; and
- a sterile tubing set to connect the console to the catheter, and through . which the heat transfer fluid is circulated to and from the catheter.
Two (2) models of the System are available: One which uses conventional, off-the-shelf thermistor probes such as esophageal probes, to monitor patient temperature and control System operation, and one that uses a thermistor integral to the catheter.
The provided text describes a 510(k) summary for the Celsius Control™ System, a thermal regulating device. However, it does not explicitly detail specific quantitative acceptance criteria or the full study protocol and results that would allow for a complete description of direct performance against such criteria. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical and clinical studies.
Based on the provided text, here's an attempt to extract and infer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of precise quantitative acceptance criteria. Instead, it makes qualitative claims about performance in comparison to predicate devices.
| Acceptance Criterion (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|
| Ability to quickly cool a subject to user-designated target temperatures | Demonstrated in non-clinical and clinical studies |
| Ability to quickly rewarm a subject to user-designated target temperatures | Demonstrated in non-clinical and clinical studies |
| Accurate control of subject temperature at a user-designated target temperature (hypothermic or normothermic) | Demonstrated in non-clinical and clinical studies to maintain temperature "within narrow tolerances" and "accurately control" temperature. |
| Safety (no measurable safety hazards) | Demonstrated in non-clinical studies ("without presenting measurable safety hazards") and clinical studies ("incidence of adverse events associated with use... is comparable to that associated with other comparable medical devices"). |
| Biocompatibility | Blood contact components "demonstrated biocompatible through testing in accordance with EN ISO 10993." |
| Electrical safety and electromagnetic compatibility | Meets applicable standards EN 60601-1-2 and EN 61003-3-3. |
| Inducing and reversing hypothermia, and maintaining normothermia | Shown through non-clinical and clinical studies to have "equivalent performance" to other thermal regulating systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "clinical studies" but does not specify the sample size for the test set. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" in the context of image interpretation or diagnosis, as this is a thermal regulating system, not an imaging or diagnostic device. The "ground truth" for performance would be objective physiological measurements (e.g., patient temperature, cooling/warming rates).
4. Adjudication Method (for the test set)
No adjudication method is described, as the studies would likely involve direct measurement of physiological parameters rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human reader performance (with or without AI assistance) is evaluated. The Celsius Control™ System is a therapeutic/regulating device.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was Done
The device is a system comprising hardware, software, and a catheter. Its performance is inherent to its operation, not an "algorithm only" in the sense of a diagnostic AI. The document describes "non-clinical tests" (both in vitro and in vivo studies) that demonstrate the device's ability to cool, warm, and control temperature. These could be considered "standalone" in that they assess the device's intrinsic capabilities.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the Celsius Control™ System would be based on objective physiological measurements such as:
- Patient core body temperature readings.
- Rates of cooling and rewarming.
- Precision of temperature maintenance.
- Incidence of adverse events.
This is inferred from the description of the device's function and the outcomes assessed in the clinical and non-clinical studies.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI, as this device's software controls are designed for thermal regulation, not for learning from a vast dataset in the traditional AI sense. The system's operational parameters would have been developed and tested, but not "trained" on a dataset in the way an AI algorithm for image recognition would be.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI/machine learning, this question is not applicable based on the provided information. The device's control system would rely on established thermodynamic principles and pre-programmed algorithms rather than learned ground truth from a training set.
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