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The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.

The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.

The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.

The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):

• Pulse rate
• Oxygen saturation
• Temperature
• Movement

The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):

• Respiration rate.

The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:

• Non-invasive blood pressure
• Lung function & spirometry
• Weight

The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.

The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor.

The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.

The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.

Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.

The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).

The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The Corsano CardioWatch 287-2 System's acceptance criteria and studies are detailed below, primarily focusing on Pulse Rate, SpO2, Respiration Rate, and Skin Temperature.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Clinical studies were carried out to support compliance to IEC IEC 80601-2-61 and FDA Guidance on Pulse Oximeters - Premarket Notification Submissions (510(k)s], March 2013." And also that the "Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System in the intended patient population using the gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram)."

However, the specific sample sizes used for these clinical studies (test set) are not provided in the given text.

The data provenance (country of origin, retrospective or prospective) is also not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the Respiratory Rate Validation Testing, the ground truth was established using a "blinded clinician." The number of these clinicians (experts) is not specified, nor are their specific qualifications (e.g., years of experience).

For Pulse Oximetry (SpO2) and Pulse Rate, the ground truth would typically come from a co-oximeter and ECG, respectively, as per the mentioned standards. The document does not explicitly state the number or qualifications of experts involved in analyzing this data beyond the implied standard procedures.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set, beyond stating that a "blinded clinician" was used for respiratory rate validation.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance is present in the provided text. The device is a patient monitoring system, not explicitly an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The performance data presented in the table and the mention of "Clinical studies were carried out to support compliance to IEC IEC 80601-2-61 and FDA Guidance on Pulse Oximeters - Premarket Notification Submissions (510(k)s]" and "Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System" indicates that standalone performance (algorithm only) was assessed for the device's measurements. The performance metrics listed (e.g., Accuracy for PR, SpO2, RR, Skin Temperature) are characteristics of the device's standalone measurement capabilities.

7. Type of Ground Truth Used

• Respiratory Rate: "gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram)." This indicates a combination of expert assessment and a validated medical device.
• Pulse Rate (PR) and Oxygen Saturation (SpO2): The document references compliance with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters (2013). These standards typically involve comparison against reference devices like an arterial blood gas co-oximeter for SpO2 and an ECG for PR, established under controlled desaturation studies or stable vital sign conditions. While not explicitly stated as "pathology" or "outcomes data," this method relies on highly accurate, established medical measurement techniques.
• Skin Temperature: Bench testing in accordance with IEC80601-2-56. This implies comparison against a calibrated reference temperature measurement.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This suggests that if machine learning models were used, the details of their training data are not included in this summary.

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

Since the document does not specify a training set or its sample size, it also does not detail how the ground truth for any potential training set was established.

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