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The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments.

The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) in infants and neonates during no-motion, motion, and low perfusion conditions.

The Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

The Masimo Stork is a wearable device that is applied to a baby's foot for the spot-checking and continuous monitoring of functional arterial oxygen saturation (SpO2), pulse rate (PR), and skin temperature. Masimo Stork is provided with wireless communication capabilities (e.g., Bluetooth) so that the parameter data can be communicated for monitoring (e.g., display, alarms).

The Stork combines the signal processing and optical components (i.e., signal detecting parts) into a single pulse oximetry module. The module is flat to allow for the flush contact with a baby (e.g., neonate, infant) foot.

Masimo Stork can be used with following components:

• 1. Stork Boot ("Boot") is a silicone holder that helps in the placement and securement of the Stork on to the baby's foot.
• 2. Stork Hub ("Hub") is an alarm/ connectivity device that helps in the communication of the physiological data wirelessly from Stork to a software application. The Hub provides the charging of the Stork and can optionally be provided with a camera.
• 3. Stork App ("App") is mobile device application that is connected through the Hub and/or directly to the Stork to provide the user interface for viewing and monitoring the physiological parameters.
• 4. Stork Cloud ("Cloud") is the software that helps to store the physiological data. It also helps to monitor the wireless connections between the Hub, App, and Stork.

Here's a breakdown of the acceptance criteria and the studies conducted for the Masimo Stork device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• SpO2 Accuracy Clinical Study: 30 subjects (14 light skin pigmented, 16 dark skin pigmented).
  • Data Provenance: Not explicitly stated regarding country of origin, but it describes a "desaturation protocol," which implies a controlled clinical setting, likely in a medical facility. The study appears to be prospective as subjects underwent the desaturation protocol.
• Form, Fit, and Function Clinical Study: 41 infants and neonates (22 dark skin pigmented, 20 light skin pigmented; 21 male, 21 female), across different ages and weights.
  • Data Provenance: Not explicitly stated, but the description of "infants and neonates across different skin pigmentations, ages, weights, and genders" suggests this was a directly collected prospective study.
• Overnight Study (Prolonged Use and Alarm Performance): 19 infants and neonates.
  • Data Provenance: "parents used the Masimo Stork overnight on their babies in a home environment." This indicates a prospective study conducted in a real-world home setting.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical studies. For the SpO2 accuracy study, it mentions comparison to an "FDA cleared pulse oximeter" (reference device K191059 - Masimo Rad-97 and Accessories including RD SET Adhesive sensors). It is implied that the reference device's measurements constitute the ground truth, which would typically be validated by medical professionals in such a clinical setting.

4. Adjudication Method for the Test Set

The document does not provide details on specific adjudication methods for the test sets. For SpO2 comparison, it states the Masimo Stork SpO2 values were compared to an FDA cleared pulse oximeter, implying the reference device's readings served as the comparative standard.

5. 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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is a direct physiological monitor, not an AI-assisted diagnostic tool that relies on human interpretation of images or other complex data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the performance specifications provided for SpO2, Pulse Rate, and Temperature describe the standalone performance of the device's algorithms. The clinical studies (e.g., desaturation study, form/fit/function study, overnight study) assess the device's accuracy in measuring these parameters, inherently evaluating the algorithm's standalone performance in a real-world physiological context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• SpO2 and Pulse Rate: The ground truth for SpO2 and Pulse Rate accuracy was established by comparing the Masimo Stork's measurements against an FDA cleared pulse oximeter (specifically, the Masimo RD SET Adhesive Sensor, K191059) during a desaturation protocol. This typically involves arterial blood gas analysis (functional oxygen saturation) in a controlled environment to validate the reference oximeter, but the text explicitly states comparison to the cleared pulse oximeter as the direct ground truth for the Stork.
• Temperature: The ground truth for temperature measurement accuracy was established using a reference temperature source during laboratory accuracy testing (in accordance with ISO 80601-2-56).
• Alarm Performance: "Good availability of the continuous monitoring" and "preventing non-actionable alarms" were qualitative or quantitative assessments from the overnight home study, likely based on user feedback and technical data logging, without a specific 'ground truth' in the same sense as physiological measurements.

8. The sample size for the training set

The document does not provide details on the training set size for any algorithms within the Masimo Stork. It states that the device "utilizes the same principles of operation as other FDA cleared Masimo SET pulse oximetry devices" and uses "advanced signal processing algorithms as part of the FDA cleared Masimo SET pulse oximetry technology." This suggests that the core algorithms are pre-existing and validated from previous devices, not newly trained for the Stork with a specific, new training set.

9. How the ground truth for the training set was established

As the document does not specify a new training set for the Masimo Stork, it does not describe how ground truth for such a set was established. It implies reliance on the established and FDA-cleared Masimo SET pulse oximetry technology, which would have had its own validation and ground truth establishment during its initial development and clearance.

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