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The Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters.

The Masimo Stork is indicated for the spot-checking and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) during no-motion, and low perfusion conditions of infants and neonates who are 0 to 18 months of age and between 6 to 30 lbs. The Masimo Stork™ is also indicated for continuous skin temperature measurements of infants and neonates who are 0 to 18 months and between 6 to 30 lbs. Masimo Stork™ is indicated for use in home environments.

The Masimo Stork can be used to supplement a caregiver's decision to seek additional guidance for the care of an infant or neonate. It is not intended to provide notifications for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2; rather, the Masimo Stork™ is intended to provide a notificient data are available for analysis.

The Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider. The Masimo Stork is not intents and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.

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 Masimo Stork can be used with the following components:

• Stork Boot: The Stork Boot is a silicone holder that helps in the placement and securement of the . Stork on to the baby's foot.
• Stork Hub: The Stork Hub is an alarm and connectivity device that helps in the communication of 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.
• . Stork App: The Stork App is a mobile device application installed on a smart device that provides the graphical user interface for the Stork for viewing and monitoring the physiological parameters.
• . Stork Cloud: The Stork Cloud is software that helps to store physiological data.

The Masimo Stork is a wearable device intended for monitoring physiological parameters in infants and neonates. The acceptance criteria and the studies performed to prove the device meets these criteria are detailed below, primarily focusing on its SpO2 (functional oxygen saturation of arterial hemoglobin) and Pulse Rate (PR) measurement performance, as well as skin temperature.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Masimo Stork's performance are derived from the specifications compared against the predicate device (Dream Sock DEN220091) and its previous clearance (K223721). The reported performance is based on the clinical studies conducted.

Note: The document primarily presents accuracy in terms of ARMS (Accuracy Root Mean Square) for SpO2 and does not explicitly state separated ARMS values for PR in the clinical study summary tables, implying that PR performance aligns with SpO2 accuracy or is established through other internal testing meeting the stated specifications.

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

The document describes three clinical studies:

• Study 1 (Equivalence to RD SET Adhesive sensor):
  • Sample Size: 30 subjects (14 light skin pigments, 16 dark skin pigments).
  • Data Provenance: Not explicitly stated but inferred to be prospective clinical data collected during desaturation studies. The country of origin is not specified.
• Study 2 (Form, Fit, and Function - Convenience Sample):
  • Sample Size: 42 infants and neonates (22 dark, 20 light skin pigmentations), across different ages and weights (0-18 months, 6-30 lbs).
  • Data Provenance: Prospective clinical data collected during a doctor's visit. The country of origin is not specified.
• Study 3 (Overnight At-Home Study):
  • Sample Size: 19 infants and neonates.
  • Data Provenance: Prospective clinical data collected in a home environment (overnight use). The country of origin is not specified.

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

The provided document does not indicate the use of "experts" in the context of establishing ground truth for the physiological measurements (SpO2, PR, Temperature). Ground truth for these parameters in medical device testing, especially for pulse oximeters, is typically established using:

• Co-oximetry (blood gas analysis) for SpO2, and simultaneous ECG or invasive arterial pressure monitoring for PR, validated against reference standards.
• For temperature, a calibrated reference thermometer would typically be used.

The statement "The first study supported the equivalence of the performance of the Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059)" implies that the RD SET Adhesive sensor served as a comparative reference, which is a common method for ground truth in this context, alongside the direct physiological measurements. The experts involved would typically be medical professionals collecting and analyzing these reference measurements.

4. Adjudication Method for the Test Set

The document does not describe any "adjudication method" in the context of expert consensus or disagreement. This is generally not relevant for direct physiological measurements where ground truth is established objectively by reference devices or clinical gold standards.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a direct physiological monitor, not an AI software interpreting images or other complex data that typically benefits from MRMC studies to evaluate human-AI collaboration. The studies focus on the device's accuracy against established references, not on improving human reader performance.

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

The performance data presented, particularly the ARMS values for SpO2, represents the standalone performance of the Masimo Stork device (algorithm only). The clinical studies directly assess how accurately the device measures SpO2 and PR compared to a reference standard, without human interpretation of the device's output being part of the core performance calculation. The device provides "notifications" and "display" to caregivers, but the core measurement accuracy is intrinsic to the device's algorithms.

7. Type of Ground Truth Used

The ground truth for the SpO2 measurements appears to be established through:

• Reference device comparison: "The first study supported the equivalence of the performance of the Masimo Stork to the FDA cleared RD SET Adhesive sensor (K191059)." This implies the RD SET sensor serves as a highly accurate reference.
• Desaturation studies: Subjects "undergoing desaturation in accordance with ISO 80601-2-61" typically involves controlled environments where arterial oxygen saturation is varied, and blood samples are drawn for co-oximetry, which is considered a gold standard for SpO2.
• For skin temperature, the ground truth would be from a calibrated reference thermometer, though details are not provided beyond the accuracy claim.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For medical devices that directly measure physiological parameters like pulse oximeters, the development often involves extensive internal testing and calibration with various physiological models and human subjects, rather than distinct "training" and "test" sets in the machine learning sense. The provided clinical studies serve as validation (test) sets for the device's final performance. If there were machine learning components, that information is not detailed here.

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

Since a separate "training set" with ground truth establishment is not described in the context of this document, this information is not available. The performance specifications are stated as inherent to the device's design and are validated by the clinical studies.

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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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