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The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A is intended for multiparameter patient monitoring with optional patient care documentation.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), Entropy (State Entropy and Response entropy) and neurophysiological status of all hospital patients.
The S/5TM Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is also indicated for documenting patient care related information.
The S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A software is indicated for use by qualified medical personnel only.

The S/5™ Compact Anesthesia Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Anesthesia Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Compact Anesthesia Monitor: L-CANE03 and L-CANE03A. L-CANE03A is equipped with extended arthythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CANE03.

The provided text describes modifications to an existing patient monitor, the Datex-Ohmeda S/5™ Compact Anesthesia Monitor, with new software versions L-CANE03 and L-CANE03A. The primary focus of the submission is to demonstrate substantial equivalence to the predicate device and ensure continued safety and effectiveness after the modifications.

Here's an analysis of the acceptance criteria and supporting study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) of the device's monitoring functions, nor does it report specific numerical performance data against such criteria.

Instead, the acceptance criteria are implicitly linked to compliance with recognized medical device standards and demonstrating substantial equivalence to the predicate device. The performance is indirectly "reported" by affirming compliance with these standards and stating that the device is "safe and effective for the intended use."

The key modifications that would typically have performance implications are:

• Improvement in QRS detection with low QRS amplitude ECG, to avoid false Asystole alarms.
• Modification of Ventricular Tachycardia definition: now 6 beats at a heart rate of 120 bpm (previously 5 beats at 100 bpm).
• L-CANE03A equipped with extended arrhythmia analysis capability (though stated to be substantially equivalent to the predicate's arrhythmia analysis).

However, specific quantitative acceptance criteria or performance metrics for these changes are not provided in the summary. The document states: "Datex-Ohmeda S/5™ Compact Anesthesia Monitor with L-CANE03 and L-CANE03A Software complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested through validation and verification of specifications."

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

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for validating the device's performance after modifications. The evaluation seems to be focused on nonclinical testing and compliance with industry standards.

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

The document does not mention using experts to establish ground truth for a test set. This type of detail is typically found in clinical validation studies, which are not explicitly detailed here.

4. Adjudication Method

Since there's no mention of experts or a test set requiring ground truth adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or mentioned in the provided summary. The submission focuses on substantial equivalence through design and software changes, and compliance with standards, rather than a clinical human-in-the-loop comparison.

6. Standalone Performance Study

The document implies a standalone (algorithm only) performance evaluation through "validation and verification of specifications" and compliance with standards like "FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm." However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are not quantitatively presented. The focus is on the process of testing against standards rather than reporting the results of such tests in a summarized form.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the context of nonclinical testing and compliance with standards for a patient monitor, the ground truth would likely be established by:

• Reference measurements/simulations: Using calibrated equipment to generate known physiological signals (e.g., ECG waveforms with specific arrhythmias, varying QRS amplitudes) to test the device's ability to accurately detect and classify them.
• Expert consensus (implied for standards): The standards themselves (e.g., IEC 60601-2-27 for ECG monitoring) are often built upon expert consensus regarding acceptable performance limits.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of information is usually relevant for machine learning algorithms, which are not explicitly detailed as a core component of this submission beyond general "data processing" and "arrhythmia analysis capability."

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

Since no training set is mentioned, there is no information on how its ground truth might have been established.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through description of modifications, affirmation of similar intended use and indications, and compliance with a comprehensive list of nonclinical safety and performance standards. It does not contain detailed quantitative performance data or descriptions of clinical validation studies often associated with diagnostic AI devices.

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