Search Results

The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensor in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the O3 Module, O3 Sensors (e.g., O3 Adult, O3 Pediatric, O3 Infant/Neonatal sensors), and a Host/Backboard Device (e.g., Root).

The Masimo O3 Regional Oximeter System provides the following measurements and calculated features:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Δbase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
• Delta SpO2 (ΔSpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (ΔHHb): Index associated with the relative change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the relative change in the oxygenated hemoglobin.
• Delta cHb (ΔcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.

The provided FDA 510(k) clearance letter and summary for the Masimo O3 Regional Oximeter (K243324) states that the submission is for an expansion of indications for existing "delta features" (ΔO2Hb, ΔHHb, ΔcHb) of the device. This means the core rSO2 measurement accuracy was not re-evaluated, as it was previously cleared under the predicate (K214072) and no changes were made to the device's fundamental operation.

Therefore, the acceptance criteria and study detailed below focus specifically on the expansion of trending ability of the delta features to new patient populations (pediatric and neonates) and non-cerebral sites.

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter (K243324)

Based on the provided document, the acceptance criteria and study focus on confirming the trending ability of the delta features (ΔO2Hb, ΔHHb, ΔcHb) for expanded indications. The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range) for these delta features, unlike the rSO2 accuracy (ARMS) specifications which are quantitative. Instead, it speaks of "strong correlation" and "equivalent performance."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Non-cerebral trending study: Data from 25 subjects.
• Pediatric/Neonatal trending study: Data from 29 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Clinical studies for 510(k) submissions are typically prospective, but this is not confirmed here.

3. Number of Experts and Qualifications for Ground Truth

• The document describes studies for "trending ability" of physiological parameters (hemoglobin changes). For such physiological measurements, the ground truth is typically established by direct physiological measurement or well-established reference methods, not by expert panel review of images or clinical assessments. Therefore, the concept of "experts establishing ground truth" in the manner of diagnostic imaging studies (e.g., radiologists) is not applicable here. The ground truth would be the actual physiological changes occurring in the subjects, measured by a gold standard method (though not explicitly detailed in the summary).

4. Adjudication Method for the Test Set

• Given that the studies are evaluating the trending ability of physiological measurements against an assumed physiological ground truth (not expert interpretations), an "adjudication method" in the sense of reconciling multiple expert opinions (e.g., 2+1, 3+1) is not applicable.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images or data with and without AI assistance to measure improvement in reader performance. The Masimo O3 Regional Oximeter is a physiological monitoring device that provides direct measurements, and the current submission is about expanding the trending indications of those measurements, not assisting human interpretation of complex medical cases.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The studies described evaluate the device's ability to trend delta features. This is a direct measurement of the device's algorithm performance in a clinical setting against physiological changes. The device itself produces these measurements, so the performance reported is inherently "algorithm only" in terms of its output, even though it's measured on human subjects.

7. Type of Ground Truth Used

• The ground truth for studies of physiological monitoring devices like oximeters is typically actual physiological values measured concurrently by a highly accurate or gold-standard reference method. For regional oximetry and hemoglobin changes, this might involve induced changes in oxygenation/perfusion and simultaneous measurement with a more invasive or laboratory-based technique, though the summary does not detail the specific reference method used for these "delta features" studies. It is implied to be a quantitative, objective physiological ground truth, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.

8. Sample Size for the Training Set

• The document does not provide information on the training set sample size. This submission is for an expanded indication based on clinical study data, not a new algorithm development submission where training data sets are typically detailed. It is assumed the algorithms for the delta features were trained/developed prior to the predicate device clearance (K214072) or during earlier development cycles, and the current submission is about validating their performance for new uses.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for any potential training set was established. As this submission pertains to an expanded indication for existing features, the focus is on clinical validation of those features in new contexts rather than the de novo development process.

Ask a specific question about this device

The Radius VSM and accessories are intended to be used as both a wearable multi-parameter patient monitor and an accessory to a multi-parameter patient monitor that is intended for multi-parameter physiological patient monitoring in hospital and healthcare facilities.

The Radius VSM and accessories are indicated for the monitoring of hemodynamic (including ECG, arrhythmia detection, non-invasive blood pressure, SpO2, Pulse Rate, PVi, heart rate, and temperature), and respiratory (e.g., impedance, acoustic, and pleth-based respiration rate) physiological parameters along with the orientation and activity of adults.

The Radius VSM and accessories are indicated for the non-invasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of well or poorly perfused adults during both no motion and motion conditions.

The Radius VSM and accessories are indicated for continuous monitoring of skin temperature of adults.

The Radius VSM and accessories are indicated for monitoring of the orientation and activity of patients including those susceptible to pressure ulcers.

The Radius VSM and accessories are indicated for the continuous non-invasive monitoring of PVi as a measure of relative variability of the photoplethysmograph (pleth) of adults during no motion conditions. PVi may be used as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient's condition and should not be based solely on PVi.

Devices with Masimo technology are only indicated for use with Masimo accessories.

Radius VSM Accessories:

Radius VSM ECG Electrodes are disposable, single-patient use ECG electrodes intended to acquire ECG signals from the surface of the body. They are indicated for use on adults for up to 3 days of skin surface contact.

Radius VSM Blood Pressure Cuffs are accessories intended to be used with a noninvasive blood pressure measurement system to measure blood pressure. They are indicated for use on adults during no motion conditions.

The Radius VSM and accessories are an FDA cleared (K223498), wearable, battery-operated, multi-modular patient monitoring platform that allows for the ability to scale and tailor the use of different monitoring technologies based upon the hospital and clinician's assessment of what technologies are appropriate.

As part of this submission, a MAP feature is being added to the Radius VSM. The feature is a software feature that uses the previously cleared systolic and diastolic measurement capabilities to automate the calculation of MAP using the following formula: MAP = 1/3* Systolic + 2/3*Diastolic.

The MAP is calculated by the Radius VSM NIBP Module and displayed on the Radius VSM Wearable Monitor. There were no other features added as part of this submission.

The provided 510(k) clearance letter and summary discuss the addition of a Mean Arterial Pressure (MAP) feature to the previously cleared Radius VSM and Accessories device. The primary focus of the performance data section is on validating this new MAP feature.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for Blood Pressure (including MAP) is:

"Meets ISO 81060-2 (Mean difference of ≤5 mmHg with a standard deviation of ≤8 mmHg)"

The document directly states that the results of the clinical testing supported the clinical performance of the MAP in accordance with ISO 81060-2. While specific numerical results (e.g., the exact mean difference and standard deviation achieved) are not explicitly provided in the summary table, the clearance implies that these metrics fell within the specified ISO 81060-2 limits for the MAP feature.

Table 1: Acceptance Criteria and Reported Device Performance for MAP Feature (as inferred from the document)

Study Details for MAP Feature Validation

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not explicitly state the numerical sample size (number of subjects/patients) used for the clinical test set. It only mentions "clinical study data."
   • Data Provenance: The document does not specify the country of origin. It indicates it was a "clinical study" and implies it was prospective ("clinical testing is provided to support its performance" for the added feature).

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

   • Not applicable as the ground truth was established by an objective reference device, not human experts.

3. Adjudication Method for the Test Set:

   • Not applicable, as the method for ground truth establishment was comparison to a reference device.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. The study was a comparison of the device's calculated MAP to invasively measured MAP from a reference device. This is a technical performance validation, not a study assessing human reader improvement with AI assistance.

5. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study. The Radius VSM automatically calculates the MAP based on the NIBP measurements (Systolic and Diastolic Pressure). The clinical testing validated the accuracy of this calculation against a reference standard, without human intervention in the MAP calculation or interpretation for the test itself.

6. The Type of Ground Truth Used:

   • Reference Ground Truth: Invasively measured MAP values from a 510(k) cleared reference device (K171801). This reference device is identified as "IntelliVue Multi-Measurement Module X3." This constitutes a device-based reference standard or instrument-based ground truth.

7. The Sample Size for the Training Set:

   • The document does not provide information about a training set since the MAP feature appears to be a direct calculation using a standard formula (MAP = 1/3* Systolic + 2/3*Diastolic) rather than a machine learning model that requires a training phase. While the device as a whole (Radius VSM) likely had training and validation phases for its other parameters, the specific "addition of a Mean Arterial Pressure (MAP) feature" is described as a software feature that "automates the calculation" using a known formula. Therefore, a separate training set for this specific MAP feature is unlikely to have been required or used in the conventional machine learning sense.

8. How the Ground Truth for the Training Set was Established:

   • As inferred above, a specific training set and ground truth establishment for this isolated MAP calculation feature are not described, given its nature as a direct formulaic calculation.

Summary of Key Information:

The core of this submission revolves around adding a simple, formula-based calculation for MAP. The primary study presented is a clinical validation confirming that the device's computed MAP aligns with a known industry standard (ISO 81060-2) when compared against an invasive reference device. This is a technical performance validation rather than a complex AI-driven diagnostic study.

Ask a specific question about this device

Masimo W1™ and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Masimo W1 also displays ECG rhythms, and the Masimo W1 Module detects the presence of atrial fibrillation. The Masimo W1 and the integrated Masimo W1 Module are intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals.

Masimo W1 Module ECG software is an over-the-counter (OTC) software that operates on the Masimo W1 Module that can be used with compatible watches (e.g., Masimo W1). The software is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG) for informational use only in adults 22 years and older. It supports the classification of either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The software is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

The Masimo W1™ and the integrated Masimo W1 Module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the Masimo W1 Module, which is the device that is responsible for the physiological signal detection and algorithm used to support the different parameters. The Masimo W1 Module incorporates spot check ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG and Masimo SET pulse oximetry parameters. As part of this submission, Masimo is requesting clearance for an automated atrial fibrillation "AFib" Classification Feature that is used to analyze the single channel ECG waveform.

The parameter outputs from the Masimo W1 Module are communicated and displayed on the watch screen so that the data can be viewed and recorded. Masimo W1 also supports wireless communication of monitored data to a compatible smart device application. The sharing of the parameter data to the applications allows the users to see and track their data using their smart phones. Smart phone applications can also help to share information to caregivers and healthcare professionals.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Masimo W1 with the Atrial Fibrillation (AFib) Classification Feature:

1. Table of Acceptance Criteria and Reported Device Performance

For the Atrial Fibrillation Classification Feature:

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

• Test Set Sample Size: The document states "Prospective clinical testing was conducted to validate the AFib Classification Feature on adult subjects from 4 different sites." While a specific number of subjects is not provided, it indicates a multi-site study.
• Data Provenance: Prospective clinical testing. The country of origin is not explicitly stated in the provided text.

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

• Number of Experts: Unspecified (referred to as "qualified clinicians" for the qualitative assessment of ECG waveforms).
• Qualifications of Experts: "Qualified clinicians" were used for the qualitative assessment of the ECG waveforms. Further specific qualifications (e.g., cardiologist, years of experience) are not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for establishing the ground truth for the test set (e.g., 2+1, 3+1). It only mentions that "qualified clinicians" made an agreement assessment.

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

• Was it done? No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described in the provided text. The study focused on the standalone performance of the AI AFib classification feature and the quality of its ECG waveform compared to a gold standard.
• Effect Size: Not applicable, as an MRMC study was not described.

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

• Was it done? Yes, a standalone performance study was clearly conducted for the AFib Classification Feature. The "Masimo W1 ECG AFib Classification feature Performance" section directly reports sensitivity, specificity, and PPV for the algorithm's output. The "Masimo W1 Module ECG software" is described as supporting the classification, indicating an algorithmic assessment.

7. Type of Ground Truth Used

• For AFib Classification: The gold standard for AFib classification is not explicitly stated, but clinical validation for ECG rhythm typically uses expert-adjudicated 12-lead ECG recordings. The document mentions "comparing similarity between Masimo W1 and gold-standard 12 lead ECG as reference" for waveform quality, which strongly implies 12-lead ECGs were used as a reference for rhythm classification as well.
• For ECG Waveform Quality: Gold-standard 12-lead ECG as reference.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only describes the test set used for clinical validation.

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

The document does not specify how the ground truth for the training set was established. It focuses solely on the validation/test set.

Ask a specific question about this device

Masimo W1 and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides the spot-checking of other continuous parameters (e.g., pulse oximetry).

The Masimo W1 and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The W1 Module incorporates ECG functionality and Masimo SET Pulse Oximetry technology so that it can provide both ECG parameters and Masimo SET pulse oximetry parameters.

As part of this submission, Bluetooth connectivity has been added to the Masimo W1 to support the wireless communication of monitored data to a compatible smart device application, such as the Masimo SafetyNet. The sharing of the parameter data to applications like the Masimo SafetyNet allows for users to see and track their data using their smart phone applications can also help to share information to caregivers and healthcare professionals.

This document is a 510(k) premarket notification from the FDA, indicating that the Masimo W1 device, with the addition of Bluetooth connectivity, has been found substantially equivalent to its predicate device (K232512). It does not contain detailed acceptance criteria and study results for the device's original performance claims (e.g., accuracy of Heart Rate, SpO2, and Pulse Rate measurements), but rather focuses on demonstrating that the addition of Bluetooth connectivity does not introduce new safety or effectiveness concerns.

Therefore, the requested information regarding acceptance criteria and performance studies for the core functionalities (like ECG heart rate, SpO2, and PR accuracy), multi-reader multi-case studies, ground truth establishment, and training set details, are not available in the provided document. The document primarily focuses on explaining that the Bluetooth addition was tested and found to not negatively impact the device's safety and effectiveness.

Here's an attempt to answer the questions based only on the information provided, highlighting what is not available:

Device: Masimo W1 (with added Bluetooth connectivity)
Device Name: Electrocardiograph (also measures SpO2 and Pulse Rate)
K Number: K240229

1. A table of acceptance criteria and the reported device performance

The document states that the Masimo W1 maintains the same performance specifications as its predicate device (K232512) for its core functionalities, implying these specifications were met in previous testing for the predicate. For the new Bluetooth functionality, the acceptance criterion was effectively that its addition does not degrade the existing performance or introduce new safety/effectiveness issues.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "non-clinical testing" including "Bench testing," "Software Verification and Validation Testing," "Wireless Testing," "Cybersecurity Testing," and "Human Factors and Usability Testing" to support the Bluetooth addition.
However, specific sample sizes for these tests are not provided.
Data provenance (country of origin, retrospective/prospective) is not specified. The studies are non-clinical and focus on functional performance and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not provided. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic imaging AI). The tests described here are primarily technical and performance-based for a vital signs monitoring device. The ground truth for SpO2, PR, and HR measurement accuracy would have been established using reference standards (e.g., arterial blood gas analysis, ECG machine) during the original clearance of the predicate device, but details are not included here for this new submission (which focuses on Bluetooth).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are typically used in clinical studies where expert consensus is required for ground truth, particularly in diagnostic or AI-assisted interpretation. This document describes technical and performance validation.

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

No MRMC study was performed or described. The device is a vital signs monitor, not an AI diagnostic tool that assists human readers in interpreting images or data. The focus of this submission is adding Bluetooth connectivity.

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

The device itself operates without a human in the loop for the measurement of parameters (Heart Rate, SpO2, PR). The "manual interpretation of heart rate" mentioned in the Indications for Use refers to a human looking at the displayed ECG and determining the rate, not the device performing an interpretation for diagnosis. The performance specifications listed (e.g., SpO2, PR, HR accuracy) are standalone claims for the device's measurement capabilities. However, details of the studies proving these specific accuracies were part of the predicate device's clearance and are not reiterated here, as this submission focuses on the addition of Bluetooth.
The document states: "The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate." This implies the device provides the data, and a human performs the interpretation.

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

For the core measurements (SpO2, PR, HR), the ground truth for the predicate device's original clearance would likely have been established using reference medical devices/methods (e.g., CO-oximeter for SpO2, reference ECG for HR, reference pulse oximeter for PR) in controlled clinical or laboratory settings. This document does not detail how the ground truth was established, as it focuses on the new Bluetooth feature. For the Bluetooth feature, the ground truth would relate to successful data transfer, communication security, and non-interference with primary functions.

8. The sample size for the training set

Not applicable/Not provided. This device is not described as using machine learning models that require a "training set" in the conventional sense. The "algorithm" for physiological signal detection and parameter determination would be deterministic or signal-processing based, not a learned model from a training set.

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

Not applicable/Not provided (as no training set is described).

Ask a specific question about this device

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.

Ask a specific question about this device

The Masimo MightySat-OTC is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR).

The Masimo MightySat-OTC is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

The Masimo MightySat-OTC is not intended for diagnosis or screening of lung disease and treatment decisions using the device should only be under the advice of a healthcare provider.

The subject device, MightySat-OTC, is a fingertip pulse oximeter that includes Masimo SET technology for the measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in individuals 18 years and older. The predicate MightySat that was previously cleared under K181956, has the same intended use as the subject device except it is cleared for prescription use only.

The subject device is identical to the predicate with the RRp and PVi parameters have been disabled in the subject device and the labeling has been modified to provide additional information on the role of pulse oximeters for OTC users. There were no hardware changes made to the MightySat Rx (predicate device, K181956) that resulted in the MightySat-OTC. Like the predicate device, the subject device, has the combined function of a pulse oximeter monitor and a reusable sensor. It includes a color display, enclosed by plastic housing, and powered by two alkaline "AAA" batteries. It also includes optional Bluetooth wireless technology for the wireless transfer of patient data to mobile device application.

Here’s an analysis of the acceptance criteria and study details for the Masimo MightySat-OTC, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size: 39 healthy volunteer subjects.
• Data Provenance: The study was a prospective clinical performance testing conducted in accordance with ISO 80601-2-61. The location of the study is not explicitly stated, but it is a clinical study involving human volunteers. Data includes varying skin pigmentation, measured using the color-based Massey-Martin scale.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For pulse oximetry, the ground truth for SpO2 is typically established through arterial blood gas analysis (reference oximeter), usually performed by trained medical professionals, but this detail is not provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). For pulse oximetry clinical studies, ground truth is generally obtained directly from standardized reference methods (e.g., CO-oximetry of arterial blood samples), not through expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a reference method for SpO2 and PR accuracy. The document mentions human factors and usability testing to validate user understanding of labeling and device outputs for OTC use, but this is a different type of study than an MRMC comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary clinical performance testing for SpO2 and Pulse Rate accuracy appears to be a standalone (algorithm only) evaluation. The device measures and displays physiological signals directly, and the clinical study evaluates the accuracy of these measurements against a reference standard. The "human factors and usability testing" is a separate evaluation of the user interface and labeling for OTC use, not directly related to the algorithm's diagnostic performance with human input.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy is based on a reference standard, specifically arterial blood oxygen saturation (SaO2), as implied by the "SaO2 range" in the performance tables. For pulse oximeters, this typically involves drawing arterial blood samples and analyzing them with a laboratory CO-oximeter.

8. The Sample Size for the Training Set

The document does not provide a specific sample size for the training set. It mentions that "the calibration curve has been adjusted to allow for improved accuracy performance, including across different skin pigments and genders." This implies that data was used to train or refine the device's algorithms, but the size and characteristics of that dataset are not detailed in this submission.

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

The document states that the calibration curve was "adjusted to allow for improved accuracy performance, including across different skin pigments and genders." While it doesn't describe the exact process for establishing ground truth for this internal adjustment/training, it would typically involve similar methods to the clinical validation: comparing the device's readings to arterial blood gas measurements from a diverse population.

Ask a specific question about this device

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.

Ask a specific question about this device

Masimo W1™ and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides other continuous parameters technologies (e.g., pulse oximetry).

The Masimo W1 ™ and the integrated Masimo W1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

The Masimo W1 is a watch that incorporates the W1 Module, which is the device that is responsible for the physiological signal detection and algorithm in providing the supported parameters. The module incorporates ECG functionality for Heart Rate Monitoring and Masimo SET Pulse Oximetry technology so that it can provide both ECG (Heart Rate parameter) and Masimo SET Pulse Oximetry parameter output from the W1 Module is displayed on the touchscreen watch interface.

As part of the Masimo W1 watch, the Masimo W1 Module is integrated into the Masimo W1 watch platform, which consists of a typical IT hardware platform to enable other non-medical smart watch features (e.g., step counting, walking, running, fall detection and rise to wake).

The provided text describes the regulatory clearance of the Masimo W1 device. It details various non-clinical and clinical tests performed to demonstrate its performance and substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly lay out a table of "acceptance criteria" in a pass/fail format with specific thresholds before the study results. Instead, it states the device's performance specifications as the target, and then presents the study results demonstrating that the device meets or exceeds these.

Here's a table based on the "Performance Specifications" listed in Table 1 and the "Clinical Performance Testing" results:

Note: For Pulse Rate and Heart Rate, the document states that testing supported the claimed performance, rather than providing a specific numerical ARMS or bias/precision value for these parameters from the clinical study itself. However, the stated acceptance criteria (specifications) are given.

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

• SpO2 Clinical Testing:
  • Sample Size: 31 healthy volunteer subjects (13 light, 12 medium, 6 dark pigmented subjects).
  • Data Provenance: Prospective clinical study. Country of origin is not specified, but typically conducted in the country of submission (USA in this case, given FDA submission).
• Heart Rate (HR) Clinical Testing:
  • Sample Size: 61 subjects.
  • Data Provenance: Prospective clinical study. Country of origin is not specified.
• ECG Waveform Quality Testing:
  • Sample Size: Not explicitly stated for specific subjects, but relates to "ECG waveforms collected by the Masimo W1."
  • Data Provenance: Not explicitly stated if prospective or retrospective, but implied from clinical validation.

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

• ECG Waveform Quality Testing:
  • Number of Experts: Three (3)
  • Qualifications: Board certified cardiologists.

For SpO2 and Heart Rate, the ground truth was established by reference devices (e.g., FDA cleared ECG reference measurement for HR, likely CO-oximetry for SpO2, in accordance with ISO 80601-2-61). The expertise for these would be in the operation and interpretation of these reference standards, not necessarily by individual expert review of each measurement.

4. Adjudication Method for the Test Set

• ECG Waveform Quality Testing: The text states, "the ECG waveforms collected by the Masimo W1 were compared to Lead I of a gold standard reference of a 12-Lead ECG by three board certified cardiologists." It doesn't specify an explicit adjudication method (e.g., 2+1, 3+1). It implies independent review by each, leading to an overall assessment of acceptability. Given "compared to... by three board certified cardiologists," it suggests independent assessments that would then be aggregated or reconciled for the overall conclusion of "acceptability."
• SpO2 and Heart Rate: No human adjudication method described. Ground truth was established using objective reference standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study involving human readers assisting with AI vs. without AI assistance was not described. The device's performance was evaluated for its ability to accurately measure physiological parameters (HR, SpO2, PR) against reference standards, and for the interpretability of its ECG waveforms by cardiologists, not for its role in assisting human interpretation or decision-making in a comparative setting.

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

Yes, for the primary physiological parameters (SpO2, Pulse Rate, Heart Rate), the device's performance relies on its integrated module and algorithms. The studies evaluate the accuracy of these measurements compared to reference standards, which is a standalone performance assessment.

• For ECG HR, the W1 module "detects and calculates the heart rate" and the single-channel ECG for the manual interpretation of heart rate. The clinical study for HR compared W1 measurements to an FDA cleared ECG reference. This suggests a standalone algorithmic performance for heart rate detection from the ECG signal.
• For SpO2 and PR, the W1 module "continuously detects and processes the optical signals" and "utilizes multiple wavelengths of light and advanced signal processing techniques" to determine these. This is a standalone algorithmic performance.

While the ECG waveform itself is for "manual interpretation of heart rate," the accuracy of the Heart Rate determination by the device itself is a standalone function.

7. The Type of Ground Truth Used

• SpO2: Clinical study results for SpO2 were conducted "in accordance with the ISO 80601-2-61," which typically means comparison to arterial blood gas measurements (CO-oximetry) as the reference standard. This is an objective, gold-standard reference method.
• Heart Rate (HR): Ground truth established by an "FDA cleared ECG reference measurement." This is an objective, reference standard device.
• ECG Waveform Quality: Ground truth established by comparison to "Lead I of a gold standard reference of a 12-Lead ECG by three board certified cardiologists." This involves expert consensus/interpretation against a clinical gold standard.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the device's algorithms. The provided details focus on the data used for performance validation (i.e., test set). Medical device submissions often do not disclose the specifics of internal development and training datasets.

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

As the training set information is not provided, the method for establishing its ground truth is also not detailed in this document.

Ask a specific question about this device

The ORi feature is intended to be used in patients undergoing surgery as an adjunct to SpO2 for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to the administration of supplemental oxygen).

The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

ORi is a device that provides an adjunct oximeter function that extends the monitoring resolution of hemoglobin oxygen saturation at elevated oxygen levels (e.g., due to the administration of supplemental oxygen). The feature is intended to be used in conjunction with SpO2 monitoring provided by a pulse oximeter. The ORi feature utilizes the similar principles of operation as pulse oximetry, utilizing hemoglobin wavelength absorption characteristics to determine relative blood oxygen saturation. Whereas SpO2 monitoring provides visibility to blood oxygen saturation in the transition from normoxia to hypoxia on the hemoglobin oxygen disassociation curve, ORi provides visibility to the transition from normoxia to hyperoxia.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ORi device are not explicitly laid out in a pass/fail table with specific metrics. Instead, the document discusses various performance aspects and mitigation measures for identified risks. However, we can infer some criteria from the "Risks to Health" and "Special Controls" sections, specifically focusing on the clinical performance aspect. The most direct performance claim for ORi is its ability to monitor hyperoxia.

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

The clinical studies involved a total of 206 subjects and 2330 data pairs (SpO2, SaO2) used for calculating ORi values.

• Masimo Clinical Lab Study:
  • Sample Size (Subjects): 52 healthy volunteers
  • Data Pairs: 939
  • Provenance: Retrospective (Masimo desaturation laboratory study)
  • Ground Truth: Reference PaO2 blood gas values from an ABL blood gas analyzer.
• Loma Linda University Study:
  • Sample Size (Subjects): 126 hospitalized participants
  • Data Pairs: 1251
  • Provenance: Retrospective (Data previously collected prospectively)
  • Ground Truth: ABG convenience samples obtained as part of standard of care.
• UC Davis Study:
  • Sample Size (Subjects): 28 hospitalized patients
  • Data Pairs: 140
  • Provenance: Prospective
  • Ground Truth: ABG (Arterial Blood Gas) drawn at specific time points.

Overall Data Provenance:

• Country of Origin: Not explicitly stated, but the institutions (Masimo, Loma Linda University, UC Davis) suggest United States.
• Retrospective/Prospective: Two studies were retrospective (Masimo Clinical Lab and Loma Linda), and one was prospective (UC Davis). The retrospective studies utilized data previously collected prospectively.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It states that:

• For the Masimo Clinical Lab study and UC Davis study, the reference PaO2 blood gas values were collected by an ABL blood gas analyzer and ABG, respectively. This implies that the ground truth for PaO2 was based on laboratory analysis of arterial blood samples, which is the gold standard, rather than expert consensus on image interpretation or clinical diagnosis.
• For the Loma Linda University study, ABG convenience samples were obtained as part of standard of care.

Therefore, the ground truth was primarily objective physiological measurement via ABG analysis, not expert interpretation.

4. Adjudication Method for the Test Set

There was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus clinical diagnosis. The ground truth was established by direct physiological measurement (Arterial Blood Gas analysis), which is considered objective and definitive for blood gas values.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described for evaluating human reader improvement with AI vs. without AI assistance. The study focused on the performance of the ORi device itself in relation to PaO2, and its benefit as an "adjunct" to SpO2, implying general clinical utility rather than a direct comparison of human performance with and without ORi assistance. The statement "benefits for detection of changing PaO2 in the range of 100 to 250mmHg better than pulse oximetry alone" suggests a comparison between ORi + SpO2 vs. SpO2 alone, but not specifically quantified for human reader improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The studies evaluated the performance of the ORi algorithm by comparing its output directly to the reference standard (PaO2 from ABG analysis). This is evidenced by:

• "ORi validation testing was performed to demonstrate the device software meets its performance requirements using patient data."
• "The pooled data demonstrated an AUC >0.8 in determination of PaO2 for the range 100-250mmHg when compared to SpO2." (This is a statistical assessment of the algorithm's output).
• "The percentage of ORi was greater than that of SpO2 for the same PaO2 values."

The device's mechanism of action and the way its output (a numeric index on a 0-1 scale) is calculated based on light absorption implies an algorithm-only function. The ORi is intended to be an adjunct to SpO2 and not a stand-alone diagnostic device, but its performance was evaluated as a standalone output (an index related to PaO2).

7. Type of Ground Truth Used

The primary type of ground truth used was Arterial Blood Gas (ABG) analysis, specifically PaO2 values. This is an objective, physiological measurement and is explicitly referred to as the "gold standard in diagnosis of hypoxemia."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a separate training set. The studies described are presented as evaluations of the device, implying they are test sets for validation. It is common for device algorithms to be developed and refined using internal datasets before these validation studies are performed, but details of such a training set are not provided here. The 206 subjects and 2330 data pairs are described as being "submitted by the sponsor for calculation of the ORi values," which might imply they were used in part for validating the final algorithm, but not necessarily for initial training.

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

Since a dedicated training set is not explicitly described, the method for establishing its ground truth is also not mentioned. If the validation data itself (or portions of it) was also used for initial algorithm development or parameter tuning, then the ground truth would have been established by Arterial Blood Gas (ABG) analysis as described for the test set.

Ask a specific question about this device

The CARESCAPE SpO2 - Masimo is intended to be used with multiparameter physiological patient monitors (e.g., GE CARESCAPE ONE) for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE SpO2 – Masimo is indicated for the continuous noninvasive monitoring of total hemoglobin concentration (SpHb) for use on adult and pediatric patients and on one patient at a time.

The CARESCAPE SpO2 – Masimo with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended to be used with compatible Philips Intellivue Patient Monitors.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is intended for the nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa).

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of carboxyhemoglobin saturation (SpCO) of adult, pediatric, and infant patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of methemoglobin saturation (SpMet) of adult, pediatric, infant, and neonatal patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of total hemoglobin concentration (SpHb) of adult and pediatric patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® is indicated for the non-invasive monitoring of respiratory rate (RRa) for adult and pediatric patients during no motion conditions.

The Masimo rainbow SET® IntelliVue Module Pulse CO-Oximeter® with Radius PPG is indicated for the continuous monitoring of functional arterial oxygen saturation of hemoglobin (SpO2) and pulse rate (PR) for use with adult, pediatric, and neonatal patients during both no motion and motion conditions and for patients who are well or poorly perfused.

The Masimo Rainbow SET IntelliVue Module Pulse CO-Oximeter is not intended to be used as the sole basis for making diagnosis or treatment decisions related to suspected carbon monoxide poisoning; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms.

The purpose of this submission is to add Radius PPG as a compatible accessory to the Carescape SpO2 -Masimo (K221953) and Masimo rainbow SET IntelliVue (K162675). The description of the subject devices is provided below:

Carescape SpO2 - Masimo: The Carescape SpO2 – Masimo is a module intended to be connected to a compatible patient monitor (e.g., GE CARESCAPE ONE, K213234) to provide the ability to continuously monitor Masimo pulse oximetry parameters (SpO2, PR, and SpHb). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

Masimo rainbow SET IntelliVue: The Masimo rainbow SET IntelliVue is a module intended to compatible patient monitors (e.g., Philips IntelliVue, K221348) to provide continuous, noninvasive measurements of functional oxygen arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), methemoglobin (SpMet), oxygen content (SpOC) and respiration rate (RRa). One end of the module interfaces with the patient monitor to communicate parameter data and alarm status information and the other end of the module connects to Masimo patient cable and sensor accessories.

This FDA premarket notification (K232389) describes the addition of the Radius PPG as a compatible accessory to two existing devices: the Carescape SpO2 - Masimo (K221953) and the Masimo rainbow SET IntelliVue (K162675). The notification states that "there were no hardware or software changes made to the subject devices as part of this submission from the previous clearances." Therefore, the performance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed for the primary devices themselves in this document, but rather for the accessory's clinical performance.

The provided document focuses on demonstrating that the addition of the Radius PPG accessory does not raise new questions of safety and effectiveness, and that the clinical performance of the Radius PPG on patients of different skin pigmentations is equivalent.

Here's an analysis of the provided information, focusing on the Radius PPG accessory's clinical performance criteria as outlined:

1. A table of acceptance criteria and the reported device performance

The document provides clinical performance data for SpO2 monitoring with the Radius PPG across different skin pigmentations. The acceptance criteria for SpO2 accuracy in oximeters are typically expressed as the "Arms" (Accuracy Root Mean Square) value. Although a specific acceptance criterion is not stated as a numerical target in the document for this submission, the reported "Arms" values are compared, implicitly seeking to demonstrate acceptable accuracy across patient populations. Standard SpO2 accuracy for oximeters without motion is usually around 2% Arms.

The reported Arms values of 1.75, 1.79, and 1.75 suggest that the Radius PPG accessory meets or exceeds typical accuracy expectations for pulse oximetry.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (for Radius PPG clinical data):
  • Subjects: 22
  • Samples: 762 (Overall)
  • Light Skin Samples: 449
  • Dark Skin Samples: 313
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, clinical data for such devices is typically collected prospectively in controlled settings to assess accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of device (pulse oximeter) does not rely on expert interpretation for ground truth. The ground truth for SpO2 measurement is typically established using a reference co-oximeter connected to arterial blood samples (invasi

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For pulse oximetry, the ground truth is derived from objective measurements (arterial blood gas analysis with a co-oximeter), so such adjudication methods are not applicable.

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

No, an MRMC comparative effectiveness study was not done. This device is a measurement device (a pulse oximeter accessory), not an AI-assisted diagnostic tool that involves human reader interpretation. Therefore, this type of study and effect size are not relevant to this submission.

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

Yes, the clinical data presented (Bias, Precision, Arms) represents the standalone performance of the Radius PPG accessory in measuring SpO2. Pulse oximeters inherently operate in a "standalone" fashion by directly measuring physiological parameters.

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

The ground truth for SpO2 measurements is typically established through arterial blood gas analysis using a laboratory co-oximeter. This provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2), against which the non-invasive SpO2 readings from the device are compared. While not explicitly stated in this summary, this is the standard method for validating pulse oximeter accuracy.

8. The sample size for the training set

The document does not explicitly mention a "training set" for the Radius PPG accessory. For traditional medical devices like pulse oximeters, the device's algorithms are developed and refined using empirical data during the R&D phase. The clinical data presented here is for validation, not training.

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

As noted in point 8, a specific "training set" with ground truth establishment is not detailed in the context of this submission for a pulse oximeter accessory. The device's underlying technology (Masimo SET and rainbow SET Pulse Oximetry) would have been developed and validated with substantial data, and its core principles rely on the physics of light absorption by different hemoglobin species.

Ask a specific question about this device