(192 days)
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.
| Feature | Acceptance Criteria (from predicate) | Reported Device Performance (for subject device) |
|---|---|---|
| SpO2 (70-100%) | $\leq$ 2% adults (No Motion/Low Perf) | 2%, adults (No Motion/ Low Perfusion) - Same as predicate |
| Pulse Rate (25-240 bpm) | $\leq$ 3 bpm adults | 3 bpm adults - Same as predicate |
| Heart Rate (25-240 bpm) | $\leq$ 5 bpm adults | 5 bpm adults - Same as predicate |
| Bluetooth Functionality | No degradation of existing performance (safety/effectiveness) | Testing was conducted to support this; found substantially equivalent. |
| Communication Security | Encryption | Application layer encryption (Implicitly met expectation) |
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).
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).