(136 days)
The LifeSense® Model LS1-9R Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of well or poorly perfused adult, pediatric and infant patients. It is intended for use in environments where patients require continuous, non-invasive monitoring of these parameters by a healthcare professional, e.g. hospitals, medical facilities, post-operative care, patient transport, home-use, or any emergency medical services and environments.
The LifeSense® Model LS1-9R is a lightweight, portable Capnography/Pulse Oximeter monitor indicated for use in simultaneously measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2), end tidal carbon dioxide (ETC02), respiration and pulse rate of adult, pediatric, and infant patients. It is intended for use in any environment where patients require continuous, non-invasive monitoring of intubated or spontaneous breathing patients.
When measuring ETCO2 the patient is attached to the monitor by a simple sample line that can be either an airway adapter for an endotracheal tube, a nasal cannula, or a nasal cannula with oxygen input.
The liquid crystal display (LCD) monitor of the Model LS1-9R displays factory default or operator defined parameters and alarm settings, ETCO2 and respiration graphs, battery status and fault messages. Operator defined settings can be made on the touch panel display.
LifeSense Model LS1-9R monitor is intended for prescription use with adult, pediatric, and infant patients.
This 510(k) summary (K063752) describes a Capnography/Pulse Oximeter monitor, which is a device for measuring physiological parameters. For this type of device, a "study" in the traditional sense of a clinical trial for diagnostic performance (e.g., sensitivity, specificity) is not typically performed or reported in the same way as for an AI/ML-based diagnostic algorithm. Instead, the "study" demonstrating the device meets acceptance criteria refers to bench and clinical testing to verify the accuracy and functionality of the measurements against established standards or reference methods.
Here's a breakdown of the requested information based on the provided text, with acknowledgments for what is generally applicable to such device submissions vs. what specifically is not mentioned in this document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly list specific numerical acceptance criteria (e.g., +/- x% accuracy) or detailed reported device performance for SpO2, ETCO2, respiration, and pulse rate. It generally states the device has "appropriate functional features" and is "substantially equivalent" to predicate devices. For these types of devices, the acceptance criteria are typically alignment with international standards for pulse oximetry (e.g., ISO 80601-2-61) and capnography (e.g., ISO 80601-2-55), which define accuracy ranges under various conditions. The "reported device performance" would consist of the results of testing against these standards, demonstrating the device operates within those defined accuracy limits. However, these specific numerical results are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The summary states that the device "has undergone both bench and clinical testing." However, it does not specify the sample size for the clinical test set (number of patients, number of measurements) or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical test).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
For a device like a Capnography/Pulse Oximeter, "experts" in the context of establishing ground truth for individual readings are typically not involved in the same way as for image-based diagnostic AI. Instead, the ground truth for parameters like SpO2 and ETCO2 during clinical testing is established using reference devices or methods that are considered highly accurate and reliable (e.g., co-oximetry for SpO2, calibrated gas analyzers for ETCO2). The document does not specify the number or qualifications of any human "experts" involved in establishing ground truth.
4. Adjudication Method for the Test Set:
Given the nature of the device and the typical ground truth establishment methods (reference devices), an adjudication method (like 2+1, 3+1) used for human expert disagreement in image interpretation is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study is designed to assess the impact of an AI system on human reader performance for diagnostic tasks. This is not applicable to a device that measures physiological parameters like a Capnography/Pulse Oximeter. The device is not an AI-assisted diagnostic tool for human readers, but rather a measurement device. Therefore, no such study was performed or reported.
6. Standalone Performance Study:
Yes, a form of "standalone" performance was effectively done by subjecting the device to "bench and clinical testing." This testing evaluates the device's ability to accurately measure and display the physiological parameters (SpO2, ETCO2, respiration, pulse rate) on its own, without a human in the loop adjusting its measurements or interpretations. The details of these tests (e.g., specific protocols, results) are not included in this summary but are submitted to the FDA during the review process.
7. Type of Ground Truth Used:
The ground truth for devices like this typically comes from:
- Reference Devices/Methods: For SpO2, this would involve arterial blood gas analysis with a co-oximeter. For ETCO2, this would involve a highly accurate and calibrated gas analyzer.
- Physiological Stimuli: For pulse oximetry, controlled hypoxia studies are often performed. For capnography, controlled ventilation or gas mixture studies are used.
The summary does not explicitly state the types of ground truth used but implies standard clinical testing procedures.
8. Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a hardware device with embedded algorithms for signal processing and measurement. Therefore, the concept of a "training set" for an AI model does not apply to this submission.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" for AI/ML does not apply. The device's internal algorithms are developed and refined through engineering, calibration, and extensive testing against known physiological signals and reference standards, rather than "training" on a labeled dataset in the AI sense.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).