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The monitors are intended to be used for monitoring, storing, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.

The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), cardiac output (C.O.), anesthetic gas (AG), bispectral index (BIS), respiration mechanice cardiography (ICG).

BIS is intended for use on adult and pediatric patients.

ICG monitoring is intended for use on adults only.

The arrhythmia detection and ST Segment analysis are intended for adult patients.

The monitors are additionally intended for use during patient transport inside hospitals.

The monitors are not intended for MRI environments.

LMPLUS series Patient Monitor including LMPLUS-12, LMPLUS-15 and LMPLUS-17 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

The LMPLUS series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which include SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure and pulse rate), TEMP, ECG, RESP (respiration), CO2, IBP, C.O. and AG (anesthetic gas), RM (respiratory mechanics), BIS (bispectral index) and ICG (impedance cardiography).

The above is the maximum configuration for LMPLUS series Patient Monitor, the user may select different monitoring parameters in according with their requirements.

LMPLUS-12 configures with 12.1-inch color TFT touch screen, LMPLUS-15 and LMPLUS-17 with same screen except different sizes 15-inch and 17-inch separately. Three models are all build-in Lithium-ion battery, support software upgrade online and networking.

The provided document focuses on the 510(k) summary for the CAF Medical Solutions Inc. Patient Monitor (models LMPLUS-12, LMPLUS-15, and LMPLUS-17), demonstrating its substantial equivalence to a predicate device (Edan Instruments, Inc. Patient Monitor, models elite V5, elite V6, and elite V8). The document primarily presents a feature-by-feature comparison and non-clinical performance data, with a brief mention of clinical tests.

Therefore, the information regarding acceptance criteria and the study proving the device meets them will be limited to what is explicitly stated in the document or can be inferred from the provided test types and standards. A full, detailed study proving acceptance criteria for specific performance metrics (like sensitivity, specificity, or inter-reader variability for an AI model) is not present in this type of regulatory submission document, which focuses on substantial equivalence to a predicate rather than a novel AI algorithm.

Based on the provided document, here's what can be extracted and inferred regarding performance and validation:

The document indicates that the device's performance was evaluated against various recognized standards for patient monitors, which inherently define acceptable performance ranges for each physiological parameter. The study primarily aims to show that the new device meets these established standards and performs comparably to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the format of a pre-defined threshold that the device must meet for a specific study's outcome (e.g., "sensitivity > X%"). Instead, it shows a feature-by-feature comparison to a predicate device, including various performance specifications (e.g., accuracy, measurement range) that are in line with industry standards for patient monitors. The "Acceptance Criteria" are implicitly defined by the parameters and accuracy/range specifications of the predicate device and the relevant IEC/ISO standards the device claims compliance with. The "Reported Device Performance" for the subject device (LMPLUS models) is stated to be "Same" as the predicate device across all listed specifications.

Here's an illustrative table based on the provided comparison, highlighting key physiological parameters:

Note: The table above is a summary of just a few representative parameters from the much larger comparison table (Table 1) in the document. The general "Acceptance Criteria" for all listed parameters are the identical specifications of the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical tests were performed on the LMPLUS 12, LMPLUS 15 and LMPLUS 17 monitors to validate their performance in terms of noninvasive blood pressure (NIBP) and SpO2 accuracy."

However, the specific sample sizes for these clinical tests (number of patients, number of measurements) and the data provenance (e.g., country of origin, retrospective or prospective nature) are not detailed in this 510(k) summary. This level of detail would typically be found in the full test report, which is referenced but not included.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions "clinical tests" for NIBP and SpO2 accuracy. For these types of physiological measurements, the ground truth is typically established by:

• Reference Devices: Using highly accurate, calibrated reference measurement devices.
• Clinical Protocols: Adhering to established clinical protocols for data collection (e.g., for NIBP, a protocol like ISO 81060-2 which often involves comparisons to invasive arterial measurements or calibrated sphygmomanometers by trained healthcare professionals).

There is no mention of human experts being used to establish "ground truth" in the context of interpretation (e.g., radiologists for imaging, unlike an AI algorithm for image analysis). The device measures physiological parameters, and accuracy is validated against established, objective measurement techniques, not expert consensus on qualitative data. Therefore, the concept of "experts establishing ground truth" as it applies to subjective judgments or interpretations (which is common for AI/ML in imaging) is not directly applicable here.

4. Adjudication Method for the Test Set

Given that the clinical tests mentioned are for quantitative physiological parameter accuracy (NIBP and SpO2), adjudication methods like 2+1 or 3+1 (common in studies involving multiple readers for subjective assessments) are not applicable. Accuracy is determined by comparing device readings to a reference standard, not by expert consensus on interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was mentioned or implied.
This device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases. Therefore, a study to measure how much human readers improve with AI assistance is not relevant to this type of device and was not performed.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

The document does not describe the device as having a distinct "algorithm" component for analysis that would be evaluated in isolation. It's a physiological monitoring device. Its accuracy in measuring parameters like NIBP and SpO2 is its "standalone performance." The clinical tests mentioned (for NIBP and SpO2 accuracy) would indeed be an assessment of the device's ability to accurately measure these parameters independently, which is effectively its standalone performance. The results are implied by the statement "the subject devices perform comparably to the predicate device."

7. Type of Ground Truth Used

For the clinical tests (NIBP and SpO2 accuracy), the ground truth would be established through:

• Reference Standard Measurements: Using a highly accurate and validated reference device (e.g., an invasive arterial line for NIBP, or a co-oximeter for SpO2) or an established standardized method as per relevant ISO standards (e.g., ISO 81060-2 for NIBP).
• Physiological Data: Direct physiological measurements, not pathology, outcomes data, or expert consensus on subjective interpretations.

8. Sample Size for the Training Set

This document describes a conventional patient monitor, not a medical device that utilizes AI/ML requiring a distinct "training set" of data to learn from. Therefore, there is no mention of a training set or its sample size. The device's algorithms for processing physiological signals are based on established engineering principles and signal processing, not machine learning from a large training dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device, this question is not applicable.

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