(583 days)
The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The technical characteristics of the Catheter are essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes.
Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users.
Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:
- Cool Line™ Catheter Kit Model CL 2085B (2 lumens)
- Cool Line™ Catheter Kit Model CL 2295A (3 lumens)
The Cool Line™ catheters are multi lumen intravascular catheters in two sizes. Two of the catheter's lumens are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm where the heating/cooling membranes interface with the patient's circulating blood. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient.
Additional lumens of the Alsius Catheters consist of a standard quide wire lumen that can be used as a primary infusion lumen, and a second or third infusion lumen within the shaft, depending on the catheter model selected by the clinician.
The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation.
The Alsius Catheters are supplied sterile for single-use only.
The provided document is a 510(k) summary for a medical device called the "Alsius CoolGard™ and Cool Line™ Catheter Thermal Regulation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the results of a clinical trial related to its safety and effectiveness for fever reduction.
It does not contain information about specific "acceptance criteria" for the device's performance in a diagnostic or classification sense, nor does it describe a study designed to prove the device meets such criteria.
The document describes the results of a randomized controlled clinical trial, but this trial assesses the safety and effectiveness of the device in a clinical context (mortality rates in different patient cohorts) rather than validating specific technical performance criteria of an AI or diagnostic algorithm.
Therefore, I cannot fulfill most of your request directly from the provided text, as the information isn't present.
However, I can extract information related to the clinical trial that was conducted:
1. A table of acceptance criteria and the reported device performance
(Not Applicable): The document does not define specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI or device. Instead, it presents mortality rates from a clinical trial to demonstrate safety and effectiveness for its intended use.
Here's the clinical trial data on mortality:
| Patient Cohort | Cool Line (n/N) | Cool Line (%) | Control (n/N) | Control (%) | p* value (Fischer's exact test) |
|---|---|---|---|---|---|
| CI | 3/16 | 18.8 | 3/14 | 21.4 | 0.74 |
| ICH | 8/33 | 24.2 | 7/27 | 25.9 | 1.00 |
| PTBI | 10/44 | 22.7 | 4/38 | 10.5 | 0.24 |
| SAH | 13/61 | 21.3 | 7/63 | 11.1 | 0.15 |
Note: CI = cerebral infarction, ICH = intracerebral hemorrhage, PTBI = primary traumatic brain injury, SAH = subarachnoid hemorrhage. The device is indicated for CI and ICH, and the warning explicitly states safety has not been demonstrated for PTBI or SAH.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The clinical study was a randomized controlled trial of 296 patients.
The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond "randomized controlled trial". Randomized controlled trials are generally prospective.
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)
(Not Applicable): This was a clinical trial assessing device safety and effectiveness (mortality rates) in patients, not a study establishing ground truth for a diagnostic algorithm based on expert review. The "ground truth" here is the clinical outcome (mortality) observed in patients.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
(Not Applicable): As above, this was a clinical trial evaluating patient outcomes, not a diagnostic accuracy study requiring adjudication of expert interpretations.
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 document describes a clinical trial for a thermal regulation system, not an AI or diagnostic imaging device that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
(Not Applicable): This is a medical device (catheter and thermal regulation system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this clinical trial was outcomes data, specifically mortality in the enrolled patient cohorts.
8. The sample size for the training set
(Not Applicable): This document describes a clinical trial for a medical device, not the development or training of an AI algorithm. There is no mention of a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
(Not Applicable): As above, this is not an AI algorithm development study.
§ 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).