(133 days)
The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician with prescription privileges determines that temperature therapy is necessary or desirable.
Indications for use for the Altrix system include:
a. Maintain pre-set body temperature as determined by the physician
b. Maintain normal body temperature during surgical procedures
c. For use in all clinical settings including coronary care units, operating, recovery and emergency departments, burn units, and medical/surgical units
d. Adult and pediatric patients
e. Monitoring and controlling patient temperature
f. Temperature reduction in patients where clinically indicated, e.g. in hyperthermic patients
Altrix components include the controller, reusable hose set(s), thermal transfer devices, patient temperature probes and reusable adaptor cable(s). The controller regulates water temperatures between 4.0 - 40.0° C and circulates the heated or cooled water via hose set(s) through the thermal transfer device(s). A graphical display provides the user an interface for selecting desired water or patient temperature settings, operating modes, help menus and other key parameters. Visual indicators are displayed to inform the user of system status or when the user must confirm a setting selection. The system's water temperature and flow outputs are monitored to ensure optimal system operation.
Note: The provided text is a 510(k) summary for a medical device (Altrix Precision Temperature Management System). It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device. This document focuses on regulatory approval and does not contain detailed information about a clinical study or performance evaluation with specific acceptance criteria and outcome metrics that would typically be found in a study report.
Therefore, for aspects like acceptance criteria expressed numerically, sample sizes for test sets, expert involvement in ground truth establishment, MRMC studies, and detailed standalone performance, the information is not present in the provided text. The document primarily discusses bench testing for software modifications and mentions "acceptable results" without quantifying them.
Here's an attempt to structure the answer based on the provided text, highlighting where information is absent and where inferences might be drawn from the context of regulatory submission:
The provided document describes the 510(k) submission for the Altrix Precision Temperature Management System, focusing on modifications to the device's software, minor components, and labeling. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (Altrix Precision Temperature Management System - K152266).
Given the nature of a 510(k) summary for modifications, the "study" proving the device meets acceptance criteria is primarily an engineering verification and validation process, not a clinical trial with human subjects testing the primary efficacy of the device.
Acceptance Criteria and Device Performance (Inferred from Regulatory Context)
Since this 510(k) is for modifications, the acceptance criteria would revolve around demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the modified device continues to meet the performance specifications established for the original predicate device. The "reported device performance" is described qualitatively as "successfully completed" and "acceptable results."
| Acceptance Criteria (Inferred from 510(k) Submission for Modifications) | Reported Device Performance (From Text) |
|---|---|
| Software Modifications: | |
| Compliance with ANSI AAMI IEC 62304:2006 (Medical device software - Software life cycle processes) and related guidances. | "Software modifications were completed using a software development life cycle process in accordance with FDA recognized standard 13-32, ANSI AAMI IEC, 62304:2006, Medical device software - Software life cycle processes, and related guidances." |
| Meet specified requirements through non-clinical bench testing. | "Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements." |
| Validate user needs with acceptable results. | "Software modifications were also validated to user needs with acceptable results." |
| Other Modifications (minor components, labeling): | |
| Meet specified requirements through verification. | "Other modifications were also successfully verified to meet specified requirements." |
| Overall Performance: | |
| Maintain substantial equivalence to the predicate device. | "The results of the non-clinical bench testing concluded that the subject device is substantially equivalent to the predicate device." |
| No adverse impact on safety or effectiveness due to modifications. | Implied by the conclusion of substantial equivalence. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified quantitatively. The testing involved "non-clinical bench testing." This typically implies testing on devices themselves rather than a dataset of patient images or readings.
- Data Provenance: Not applicable in the traditional sense of patient data. The "testing" refers to the verification and validation of software and hardware changes on the device itself.
- Retrospective or Prospective: Not applicable as it's bench testing, not a clinical data study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this was bench testing for software and minor component modifications, the "ground truth" would be established by engineering specifications, validated test protocols, and potentially expert review of the software design and functionality, rather than human experts labeling medical data.
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Adjudication method for the test set:
- Not Applicable. There is no mention of human adjudication for the test results described, as the testing focuses on internal device performance against specifications.
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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. An MRMC study was not conducted. This device is a thermal regulating system, not an imaging AI diagnostic aid, and the submission is for device modifications, not a de novo AI product. The text does not mention any AI components assisting human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Applicable / Assumed. The "Software modifications were also validated to user needs with acceptable results" and "Non-clinical bench testing was successfully completed to verify the software modifications meet specified requirements" implies testing the algorithm's performance in isolation to ensure it functions as intended based on its design specifications. However, specific standalone performance metrics (e.g., accuracy, precision for a measurement) are not provided in this summary.
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The type of ground truth used:
- Engineering Specifications / Functional Requirements. For software and hardware modifications, the "ground truth" is defined by the device's design specifications, functional requirements, and the expected output under various conditions, as opposed to clinical outcomes or expert consensus on patient data.
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The sample size for the training set:
- Not Applicable. This is a 510(k) for modifications to a traditional medical device, not a machine learning or AI model development that requires a "training set" of data.
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How the ground truth for the training set was established:
- Not Applicable. (See point 7).
§ 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).