(8 days)
The ChillBuster® Model 8002 has been developed to reduce the effects of hypothermia encountered during the trauma of a surgical procedure or other medical crisis which could result in the onset of a hypothermic condition. Use is limited to whole-body warming in adult humans, free of skin conditions or other impairments where distributed heat application is deemed contraindicated by the responsible physician.
This device, as now cleared, permits use with either a sterile or a non-sterile blanket cover, as necessary, upon the determination by a health care practitioner. Most intended use does not involve surgery. Also, even during surgery, only those interventions where the blanket cover would threaten a sterile operating field actually require a sterile blanket cover to achieve intended function. The present design modification involves no change to intended use, indications for use, technological basis, device design, or substantial equivalence. And both the ChiliBuster® Predicate and Modified devices require use of a blanket cover with every therapy session. For ThermoGear's ChillBuster® product, the only Predicate/Modified device difference lies in labeling that addresses when to use a sterile versus non-sterile blanket cover. While the Predicate 8002 requires use of a sterile blanket cover for every therapy, the Modified 8002 "requires the decision to use a sterile or a non-sterile blanket the woulded by a medical practitioner, familiar with the patient's condition and circumstance."
This 510(k) summary (K083135) describes a modification to the ChillBuster® Model 8002 Portable Electric Blanket, specifically regarding the labeling for when to use sterile versus non-sterile blanket covers. It is not a study demonstrating device performance against specific acceptance criteria. Instead, it is a statement affirming that the modified device is substantially equivalent to its predicate device and that the change is a labeling update, not a change requiring new performance data.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as this submission explicitly states no performance data was required for this particular change.
Here's why each point is not applicable based on the provided document:
1. A table of acceptance criteria and the reported device performance
Not Applicable. The document explicitly states: "Clearance of the subject of this submittal, requirements of when to use a sterile or non-sterile blanket cover, does not require performance data. The two cover types are the same in every way, save the state of sterility." Since no performance data was collected or required, there are no acceptance criteria or reported device performance for this specific modification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable. No performance testing was conducted for this specific labeling modification, so there is no test set or associated data provenance.
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. As no performance testing was performed, there was no need for experts to establish ground truth for a test set. The change is related to the decision of a medical practitioner (implied expert in clinical practice) regarding sterility, not a diagnostic or therapeutic performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No performance testing was performed, so no adjudication method was used for a test set.
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 device is a portable electric blanket, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a hardware device (electric blanket) and not an algorithm. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable. No performance testing was performed, so no ground truth was established for the purpose of evaluating the modified device's performance. The "ground truth" for the submission is the regulatory and clinical understanding that practitioners can determine when a sterile vs. non-sterile cover is needed.
8. The sample size for the training set
Not Applicable. This device uses a predicate device model; it doesn't involve machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, there is no ground truth to establish for it.
In summary, the provided document describes a regulatory submission for a labeling change to a medical device, not a study evaluating its performance against specific technical criteria. The core argument is that the change itself (allowing practitioner discretion for blanket cover sterility) does not impact safety or effectiveness and therefore does not require new performance data.
§ 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).