(49 days)
The Life Support for Trauma and Transport (LSTAT) G6 Lite System is a portable unit intended to supply intensive care unit (ICU) functionality for adult and pediatric patients. The LSTAT G6 Lite combines the following medical device capabilities into a single platform: Physiological monitoring (electrocardiogram, invasive pressure monitoring, non-invasive blood pressure monitoring, temperature, pulse rate, blood oxygen saturation, and heart rate), low rate and high rate infusion pumps, a fluid warmer, a ventilator with carbon dioxide monitoring capabilities, and the ability to deliver oxygen to a patient. The functions of the LSTAT G6 Lite are controlled from a central user interface. The G6 Lite may be operated using either battery power or an external power source. The G6 Lite is intended to be used in hospitals, aircraft, ambulances, field hospitals, and extended care facilities.
The Integrated Medical Systems LSTAT G6 Lite is a portable intensive care unit (ICU) for adult and pediatric patients. The LSTAT G6 Lite combines the medical device capabilities of a physiological monitor, a ventilator, and infusion pumps into a single platform with a central display.
The provided text is a 510(k) summary for the Integrated Medical Systems LSTAT G6 Lite. This document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this document, as it is not a performance study report.
Here's what can be inferred or explicitly stated based on the document's content:
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A table of acceptance criteria and the reported device performance:
- Information not provided. The document states that "The Integrated Medical Systems LSTAT G6 Lite is substantially equivalent to the Integrated Medical Systems LSTAT 9602 (K965117) since the basic features, design and intended uses are the same or similar." It also says, "The differences in design, dimensions, and features between the LSTAT G6 Lite and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function, or intended use of the device." This implies that the device is expected to meet the same performance standards as its predicate, but specific acceptance criteria (e.g., accuracy, precision, response time for physiological parameters) and detailed performance results are not presented in this summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not provided. This summary does not describe a performance study with a test set.
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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):
- Information not provided. This summary does not describe a performance study with expert ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not provided. This summary does not describe a performance study with a test set.
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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:
- Not applicable. The LSTAT G6 Lite is a portable intensive care unit combining physiological monitoring, ventilator, and infusion pump capabilities. It is not an AI-assisted diagnostic device, and therefore an MRMC study with human readers improving with AI assistance is not relevant to its type of submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As the LSTAT G6 Lite is a medical device incorporating multiple functions (monitoring, ventilation, infusion), the concept of "standalone algorithm performance" as typically applied to diagnostic AI is not relevant. Its performance would be evaluated as an integrated system, and the submission relies on substantial equivalence.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information not provided. This summary does not describe a performance study that would establish ground truth in this manner. The "ground truth" for this submission is implicitly the established safety and effectiveness of its predicate device, K965117.
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The sample size for the training set:
- Information not provided. This summary does not describe the development or training of an algorithm.
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How the ground truth for the training set was established:
- Information not provided. This summary does not describe the development or training of an algorithm.
In summary, the provided document is a 510(k) summary declaring substantial equivalence for a physical medical device, not a report detailing a clinical performance study with acceptance criteria for an AI or diagnostic algorithm.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).