(309 days)
The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive carc.
The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.
The provided text is a 510(k) Summary of Safety and Effectiveness document for the SetPoint® Endovascular Temperature Management System. It describes the device, its intended use, and states that performance tests were conducted. However, the document does not contain acceptance criteria or specific details of the study that proves the device meets those criteria.
It only states:
- "The SetPoint® Endovascular Temperature Management System has been tested for system performance."
- "In addition the Catheter has been tested for functionality in accordance to the BS EN ISO 10555, for biocompatibility in accordance to ISO 10993."
- "The controller has been tested for electrical safety in accordance to EN 60601."
- "Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint® Endovascular Temperature Management System consisting performs with similar safety and effectiveness."
Therefore, I cannot provide the requested information for acceptance criteria and the detailed study because it is not present in the provided text.
Based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document states that performance tests were conducted and "successful," but does not list specific acceptance criteria or the numerical results of those tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "performance tests" but does not specify the sample size used, the origin of the data, or whether the study was retrospective or 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 device is a thermal management system, not an imaging or diagnostic device that typically relies on expert ground truth for classification or diagnosis. The "performance tests" would likely involve objective measurements rather than expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Same as above, adjudication methods are typically used for diagnostic or classification tasks with expert review, which is not relevant for this type of device performance testing.
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 is not an AI-assisted diagnostic or imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a medical device for temperature management, not an algorithm, so "standalone" performance in the context of an algorithm is not relevant. The "system performance" tests would be considered the standalone performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available/Not Applicable (for ground truth as in diagnostic context). For a thermal management system, "ground truth" would likely refer to objective measurement standards for temperature control, flow rates, electrical safety, and biocompatibility. The document refers to standards like BS EN ISO 10555, ISO 10993, and EN 60601, which define the methods and criteria for these objective measurements.
8. The sample size for the training set
- Not Applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As this is not a machine learning algorithm, there is no training set or associated ground truth establishment process in this context.
§ 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).