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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.

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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).

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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.

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