Search Results
Found 301 results
510(k) Data Aggregation
(241 days)
Indications for Use:
The MAC 7 Resting ECG Analysis System is a non-invasive prescription device.
- The device is indicated for use to acquire, analyze, display and print electrocardiograms.
- The device is indicated for use to provide interpretation of the data for consideration by a physician.
- The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.
Intended Use:
The MAC 7 Resting ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult or pediatric populations. Basic system simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. Transmission and reception of ECG data and other clinical data to and from a central clinical information system is optional.
The MAC 7 Resting ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital, medical professional's facility or wherever ECG testing is performed.
The MAC 7 Resting ECG Analysis System is a mobile electrocardiograph designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes.
The device can capture 3, 6, 12 or 15 lead electrocardiograms, provide interpretive analysis, and print reports.
The device can connect to a network, either through a wired LAN connection or via wireless WiFi access points. Once on the network, the device can optionally interface with cardiology information systems such as the GEHC MUSE® system to participate in a complete electrocardiology workflow.
The device provides state-of-the-art information technology security features and a contemporary user interface. Mobility is provided via an optional trolley.
The FDA 510(k) clearance letter for the MAC 7 Resting ECG Analysis System (K251670) does not contain a specific study proving the device meets acceptance criteria. Instead, it establishes substantial equivalence to predicate devices (K203786, K173830, K210560) based on similarities in intended use, indications for use, technology, and performance, along with compliance with voluntary standards and non-clinical testing.
Therefore, the following information is extracted from the provided text to fulfill your request:
1. Acceptance Criteria and Reported Device Performance
The document describes the device's characteristics and compares them to predicate devices, demonstrating substantial equivalence rather than explicit acceptance criteria with numerical performance targets. The "Discussion of Differences" column often highlights that a change does not significantly affect substantial equivalence, implying that the performance remains acceptable.
| Specification | Predicate Product: MAC 7 Resting ECG Analysis System (K203786) | Proposed Product: MAC 7 Resting ECG Analysis System | Reported Device Performance (as implied by "Discussion of Differences") |
|---|---|---|---|
| Intended Use | As described in the predicate | As described in the proposed product | Equivalent: "The change in the intended use statement reflects the flexibility of the system without impacting the core functionality or safety profile." and "The change in the intended use statement doesn't alter the substantial equivalence of the device." |
| Indications for Use | As described in the predicate | As described in the proposed product | Equivalent: "The updated language to include healthcare practitioner broadens the description to reflect current clinical practices without altering the device's safety or performance." |
| Contraindications | As described in the predicate | As described in the proposed product | Identical |
| Patient Population | Adult and pediatric (birth through 21 years of age), with ACS interpretation exception < 16 years. | Adult and pediatric (birth through 21 years of age), with Lead reversal detection exception ≤ 15 years and ACS interpretation exception < 16 years. | Substantial Equivalent: "The subject device maintains full alignment with the adult and pediatric patient population indications of the predicate and reference devices." and "Age-related limitations for Lead Reversal Detection and ACS interpretation are consistent with those of the predicate/reference devices and do not alter the overall patient population equivalence." |
| Environment of Use | As described in the predicate | As described in the proposed product | Identical |
| Patient Acquisition Circuitry | Integrated in the device, digitalizing functions provided by the device. | Integrated in the device, digitalizing functions provided by the device. | Identical (for comparison with MAC 7 predicate); Equivalent: "The proposed device uses the same acquisition module as the reference device. The only difference is that the proposed product uses a standard USB port. These differences do not affect the substantial equivalence of the device." (for comparison with MAC VU360 reference) |
| Interpretive ECG Analysis | Yes | Yes | Identical |
| Critical Values | Identified, indicated via dialog box and printed report; user acknowledgement required. | Identified, indicated via dialog box and printed report; user acknowledgement required. | Identical |
| ECG Pacemaker Detection and HD Pace | Digital detection, separate printable/viewable channel; 12SL disabled for acquisition module detections. | Digital detection, separate printable/viewable channel (configurable on/off, default enabled); 12SL disabled for acquisition module detections. | Substantial Equivalent: "The change involves adding the ability to configure the separate pacemaker pulses channel to enable or disable detection, with the default setting being enabled. This modification provides additional flexibility without affecting the device's core functionality or safety." |
| Frequency Response | 0.04 to 150Hz | 0.04 to 300Hz (default 0.04 to 150Hz) | Equivalent: "The proposed product expands bandwidth support from 150 to 300Hz as included in the K221321. There was no change in measurements or accuracy... The difference does not significantly affect substantial equivalence." |
| Prior ECG | Not supported | Download, review, print recent previous ECG from same patient. | Equivalent: "The proposed MAC 7 can download the most recent previous ECG from the ECG management server for the same patient. This change has been verified to not significantly impact substantial equivalence." (for MAC 7 predicate); Equivalent: "The design of the Prior ECG feature uses current patient identification to query historical ECG data from the management system, enabling the retrieval and comparison of the most recent previous ECG with the current one from the same patient. The output of this process is consistent between the proposed and reference device. The only notable difference is in the labelling of the printed report, where MAC 7 V2 displays "Prior ECG" while TC30 uses "Previous ECG"... The labelling difference does not alter the functionality, or performance of the feature. Therefore, the addition of this feature does not impact the substantial equivalence of the proposed device." (for TC30 predicate) |
| Display type, size, resolution, and information | 10 inch diagonal LCD, 1280 x 800, displays patient name, lead label, patient I.D., heart rate, date/time. | 10 inch diagonal LCD, 1280 x 800, displays patient name, lead label, patient I.D., heart rate, date/time. | Identical |
| Battery Operation | Rechargeable and user replaceable | Rechargeable and user replaceable | Identical |
| Recorder Method | Thermal dot array | Thermal dot array | Identical |
| Number of Channels | Selectable 3, 6, or 12 channels + pace annotation | Selectable 3, 6, 12 or 15 channels + pace annotation | Equivalent: "The proposed device supports up to 15 channels due to the addition of three more electrodes and their corresponding signal acquisition." |
| Thermal Paper size | A4 or Letter format, thermal paper Z-fold | A4 or Letter format, thermal paper Z-fold | Identical |
| Network Printer Option | Not supported | Support to print report via network printer | "The contents of the network printer reports are the same as thermal printer reports." (Implies acceptable performance by producing identical reports) |
| eDelivery | Not supported | Support for self-registration, activation, and software update notifications. | "This is a service feature which make it easier to deliver new software version to customer, it does not affect substantial equivalence." (Implies acceptable performance as it doesn't impact core function) |
| RSvP | Not supported | Support to upload service snapshot to remote server. | "This is a service feature which make it easier to get device data for trouble shooting, it does not affect substantial equivalence." (Implies acceptable performance as it doesn't impact core function) |
| Interpretation Statements | 12SL™ analysis algorithm (v23.1) for 10 seconds ECG. | 12SL™ analysis algorithm (v24) for 10 seconds ECG. | Equivalent: "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321... The difference does not significantly affect substantial equivalence." (Implies performance is acceptable as per prior clearance) |
| Lead Reversal Detection | Limb lead reversal detection | Limb lead and chest lead reversal detection. | Equivalent: "The primary change involves an algorithm update from 12SL (v23.1) to 12SL (v24), which allows the detection of additional lead reversals without altering the core substantial equivalence of the device. The MAC 7 interface presents the new detection capability, without compromising the device's safety and performance." |
| Acute Coronary Syndrome (ACS) | Provides interpretation statement for ACS. | Provides interpretation statement for ACS. | Identical |
| Dimensions and Weight | 40 x 32 x 21 cm, 5.2 Kg | 40 x 32 x 21 cm, 5.2 Kg | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Summary of Clinical Tests: The subject of this premarket submission, MAC 7 Resting ECG Analysis System, did not require clinical studies to support substantial equivalence." This indicates that no specific test set data from clinical studies was used for performance evaluation in this submission. The "acceptance" is based on the device's technical characteristics aligning with or improving upon those of legally marketed predicate devices, supported by non-clinical testing and previous clearances for core components (like the 12SL™ analysis algorithm v24).
Therefore, details on sample size, country of origin, or retrospective/prospective nature of a clinical test set are not available in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
As no clinical studies were required for this submission to support substantial equivalence, there is no information provided regarding experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Given that no clinical studies were performed, there is no adjudication method described for a test set.
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
The document does not mention any MRMC comparative effectiveness study. The focus is on establishing substantial equivalence to existing devices, not on demonstrating improved human reader performance with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The document states that the "Interpretive Statements are provided by 12SL (v24) ECG Analysis Program which was previously cleared under K221321." This implies that the performance of the 12SL™ algorithm itself (a standalone interpretation algorithm) would have been assessed during its prior clearance (K221321). However, the details of that standalone performance study are not included in this K251670 submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Since no new clinical studies were performed for this submission, there is no mention of the type of ground truth used for a test set. For the 12SL™ analysis algorithm (v24) which provides interpretation statements, the ground truth would have been established during its prior clearance (K221321), but those details are not provided here.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for any training set. As noted, the approval is based on substantial equivalence and non-clinical testing rather than specific training data for a new algorithm.
9. How the Ground Truth for the Training Set was Established
The document does not provide information on how ground truth was established for any training set.
Ask a specific question about this device
(146 days)
The AccurECG® Analysis System v2.0 is intended for use by qualified healthcare professionals in the assessment of a patient's recorded ambulatory ECG data. Analysis results are provided in a standard report for review and printing.
The System provides single-lead analysis on a beat-by-beat basis, Ventricular Ectopic Beat and Supraventricular Ectopic Beat detection, heart rate measurement, and rhythm analysis. The AccurECG® Analysis System v2.0 is compatible with ECG recordings taken with silver/silver chloride (Ag / AgCl) electrodes (wet leads).
The AccurECG® Analysis System v2.0 is not for use in life-supporting or sustaining systems or ECG monitor and alarm devices. The System is not intended to be used with cardiac telemetry monitors.
The AccurECG® Analysis System's automated interpretation results are not intended to be the sole means of diagnosis. The AccurECG Report is an adjunct intended to facilitate health care decision making in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information to arrive at a diagnostic conclusion.
The AccurECG® Analysis System v2.0 does not interface with data management systems or hardware and is device independent.
The AccurKardia ECG Analysis System consists of: (1) A client-side web interface which provides tools to upload and review ECG recordings via a web application programming interface (API), and (2) A server-side automated proprietary ECG interpretation support algorithm which measures and analyzes ECGs to provide physicians supportive information for ECG analysis.
AccurECG v2.0 is intended to analyze recordings performed on adults aged 22 and older and works in the following sequence:
i. The web interface allows the user to select files and upload to the AccurECG secure database.
ii. The proprietary AccurECG algorithm analyzes and labels the ECG:
- Delineation – detection of QRS complexes and T waves on the ECG signal through advanced signal processing and image-based techniques.
- Abnormality labels – automated arrhythmia interpretation and statistical classification.
iii. AccurECG® Analysis System v2.0 displays the resulting analysis and original ECG signal with reviewing tools in the web interface.
iv. AccurECG® Analysis System v2.0 allows for preliminary comments summarizing the review before generating a report.
N/A
Ask a specific question about this device
(96 days)
Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older.
Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.
Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Withings BeamO, model name SCT02, is a multi-function handheld battery powered device with ECG, stethoscope, temperature capabilities. Withings BeamO can record a 1-lead ECG using two stainless steel electrodes. It analyzes the data collected by the integrated two stainless steel electrodes to generate an one-lead ECG waveform and provides the ECG recording to the user for a given 30 second measurement.
Withings BeamO is also a contactless thermometer that can measure body temperature in adjusted mode.
Withings BeamO is also a digital stethoscope that can be used to auscultate heart and lung sounds. The sensor generates an electric charge when subjected to mechanical vibrations. The charge variations are amplified and digitized by an audio codec. Sound filters are applied to the resulting sound wave in order to listen to the patient's heart and lung sounds with clarity.
Withings BeamO consists of hardware and embedded software. Withings BeamO works in conjunction with a companion software on the Withings App. Withings BeamO communicates with the companion software via Bluetooth Low Energy (BLE). The device measurement results and recordings are synchronized with the companion software using Wi-Fi/Cellular data via the Withings servers.
Withings BeamO does not include ECG analysis or ECG-derived heart rate functionalities.
N/A
Ask a specific question about this device
(161 days)
The Cardiologs Holter Platform is intended for use by qualified healthcare professionals for the assessment of arrhythmias using ECG data in the adult and pediatric population.
The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices indicated for recording heart rhythm.
The Cardiologs Holter Platform can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.
The Cardiologs Holter Platform provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement and rhythm analysis. The Cardiologs Holter Platform is not for use in life supporting or sustaining systems or ECG monitor and physiological alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
Cardiologs Holter Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns patient background, clinical history, symptoms, and other diagnostic information.
Cardiologs Holter Platform is comprised of:
- An interface, which provides tools to measure, analyze and review numerous ECGs;
- An automated proprietary ECG interpretation support algorithm using artificial intelligence (AI) to analyze ECGs to provide clinicians with supportive information for ECG diagnosis.
Cardiologs Holter Platform is an online portal that can be accessed through a network connection and allows the clinician to review and annotate the ECG signals. Alternatively, the Cardiologs Holter Platform can be accessed via an Application Programming Interface (API) connection. The API connection allows a digital ECG upload from a connected device and allows the connected device to receive the output of the Cardiologs ECG interpretation support algorithm and further process and display its output in their system.
Cardiologs Holter Platform is intended to analyze recordings from devices used for the arrhythmia diagnostics such as Holter, event recorder, 12 lead ambulatory ECG devices, or other similar devices for the assessment of heart rhythm in adult and pediatric populations.
Cardiologs Holter Platform works in the following way:
-
Upload of a digital ECG file to Cardiologs' secure hosting databases;
- i. Manual upload: via the web-interface
- ii. Direct upload: no manual intervention required, upload occurs whenever the third-party hardware or software system is connected to the Cardiologs' Application Programming Interface (or API) and the ECG is automatically sent to the Cardiologs' servers.
-
Processing of the uploaded ECG file;
-
Analysis and annotation of the uploaded ECG performed by Cardiologs' proprietary algorithm;
-
Display the analysis of the ECG, along with the original signal, to the clinician for review of patient data. The algorithm output may be accessed/displayed through the following interfaces:
- i. The clinician can access the algorithm output directly within Cardiologs using Cardiologs' user interface.
- ii. The clinician can access the algorithm output in their own downstream system. The downstream system receives the output of the algorithm via Cardiologs' Application Programming Interface (API).
- The Cardiologs Holter Platform allows for editing and/or validation of the measurements and parameters by the analyzing clinician.
-
A PDF report is generated as the result of the analysis.
The provided FDA 510(k) clearance letter for the Cardiologs Holter Platform (K250569) does not contain the detailed information required to describe the acceptance criteria and the specific study proving the device meets these criteria.
The letter states:
- "Performance testing demonstrates that the proposed device is as safe and effective and performs as well as the predicate." (Page 6 & 7)
- "No clinical testing was performed in support of this premarket notification." (Page 7)
- "The modified device includes performance updates to enhance the accuracy of the currently cleared abnormalities and measurements and expanded pediatric indications." (Page 6)
This indicates that internal performance testing was conducted, likely against the predicate device's performance, but the details of these tests (acceptance criteria, performance results, sample sizes, ground truth establishment, etc.) are not included in this public facing letter. Such information would typically be found in the full 510(k) submission document, which is not provided here.
Therefore, I cannot fulfill your request with the given input. The document is a clearance letter, which summarizes the outcome of the FDA's review, but does not detail the technical studies and their results.
Ask a specific question about this device
(268 days)
ZBPro Diagnostic is a cloud-based medical device intended for use by qualified healthcare professionals in the detection and analysis of common cardiac arrhythmias in Holter ECG data in the adult, non-paced population.
The product supports downloading and analyzing Lead II, CM5 (Ch 1), or Modified-MLII (Ch 2+) on retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings collected using standard Ag/AgCl wet electrodes in adult, non-paced patients. ZBPro is not intended for use with multi-lead analysis, wearable patches, or pediatric/paced recordings.
ZBPro Diagnostic can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system.
ZBPro Diagnostic provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis.
ZBPro Diagnostic is not for use in life-supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into computerized ECG monitoring devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
ZBPro Diagnostic interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
ZBPro is cloud-based Software as a Medical Device which aids healthcare professionals in interpreting ambulatory ECG recordings. The software comprises a secure web interface and a backend server hosted on Amazon Web Server (AWS). Authenticated users upload compatible 24-48 hour Holter ECG recordings via a web browser through an Application Programming Interface (API). ZBPro's proprietary ECG interpretation algorithm analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis.
ZBPro provides beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis.
ZBPro consists of:
- A web interface which provides tools to upload data, measure, analyze and review numerous ECGs and patient diary logs, make manual annotation and generate ECG reports.
- An automated proprietary ECG interpretation algorithm which measures and analyzes ECGs to provide adjunct information for ECG diagnosis.
The backend application is established in Amazon Web Services (AWS) and accessed through an Internet connection and a web browser to perform ECG analysis and generate reports.
The provided FDA 510(k) clearance letter and summary for ZBPro Diagnostic contains information related to the device's acceptance criteria and the study conducted to prove it meets them. However, it does not provide explicit details for all the requested points, particularly numerical metrics for acceptance criteria and specific performance results. Instead, it refers to compliance with standards and successful completion of validation.
Here's an extraction of the available information, with notes on what is not explicitly stated:
Acceptance Criteria and Reported Device Performance
The document states that "All clinical input requirements were validated against a gold standard," and "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database in accordance with ANSI/AAMI EC57 and IEC 60601-2-47 reporting conventions." This implies the acceptance criteria were defined by these standards. However, the exact numerical thresholds for sensitivity, specificity, accuracy, etc., for each specific arrhythmia or beat type, are not explicitly stated in the provided text. Similarly, the reported numerical device performance (e.g., specific percentages for sensitivity or specificity) is also not given.
The table below reflects what can be inferred or is directly mentioned regarding the device's performance against its expected functions, without specific quantitative results.
| Acceptance Criteria (Implied from Standards & Functions) | Reported Device Performance (Inferred from "met requirements" and "successful") |
|---|---|
| Detection and analysis of common cardiac arrhythmias in Holter ECG data (adult, non-paced population, Lead II, CM5, Modified-MLII) | The software successfully provides "ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, R-R interval measurement, heart rate measurement, and rhythm analysis." The validation testing was "successful and met all requirements." |
| Compliance with AAMI ANSI EC57:2012 (Testing and Reporting Performance Results of Cardiac Rhythm And ST-Segment Measurement Algorithms) | Performance validation testing was conducted "in accordance with ANSI/AAMI EC57... reporting conventions" and was "successful." This implies the device met the performance expectations outlined in this standard for relevant rhythm and beat detection. (Specific performance metrics are not provided in this document) |
| Compliance with AAMI ANSI IEC60601-2-47:2012 (Particular Requirements For The Basic Safety And Essential Performance Of Ambulatory Electrocardiographic Systems) | Performance validation testing was conducted "in accordance with... IEC 60601-2-47 reporting conventions" and was "successful." This implies the device met the basic safety and essential performance requirements for ambulatory ECG systems. (Specific performance metrics are not provided in this document) |
| ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate, and rhythm analysis. | ZBPro's proprietary ECG interpretation algorithm "analyzes and annotates ECGs to provide supportive information for ECG and arrhythmia analysis" and provides "beat-by-beat ECG signal processing and analysis, QRS detection, Ventricular Ectopic Beat detection, R-R interval measurement, heart rate and Heart Rate Variability measurement, and rhythm analysis." All software validation testing was "completed successfully and met all requirements." |
| Robustness under degraded signal conditions (noise stress testing) | "Additional noise stress testing using the ZBPro Noise Stress Testing (ZNST) database was conducted to evaluate algorithm robustness under degraded signal conditions." Implied successful completion, as overall conclusion is substantial equivalence. (Specific results are not provided) |
| Usability for healthcare professionals (Certified Cardiovascular Technicians) | "General usability tests... were performed by certified cardiovascular technicians and met all requirements." Usability tests were conducted to "validate the effectiveness of risk control measures associated with the user interface." |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "an adjudicated database" for performance validation testing but does not specify the sample size (number of patients or recordings) used for this test set.
- Data Provenance: The document does not specify the country of origin of the data. It states the testing was done on "retrospective 3-lead and 5-lead 24/48-hour Holter ECG recordings." This confirms the data was retrospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This implies that experts were involved in adjudication to establish ground truth. However, the number of experts used and their specific qualifications (e.g., radiologist with X years of experience) are not explicitly stated.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The term "adjudicated database" is used, indicating that a formal process was followed to establish ground truth. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly described in the provided text.
-
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 comparative effectiveness study involving human readers with and without AI assistance is mentioned. The study described focuses on the standalone performance of the algorithm against an adjudicated ground truth and user interface usability.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation of the algorithm was conducted. The document states: "Performance validation testing included comprehensive rhythm classification analyses on an adjudicated database." This refers to the algorithm's performance independent of a human-in-the-loop scenario.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established through expert consensus/adjudication, as indicated by the phrase "adjudicated database."
-
The sample size for the training set:
- The document does not provide any information regarding the sample size of the training set used for the ZBPro Diagnostic algorithm.
-
How the ground truth for the training set was established:
- The document does not provide any information on how the ground truth for the training set was established. It only refers to the "adjudicated database" for performance validation testing (typically the test set).
Ask a specific question about this device
(164 days)
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:
| Performance Metric | Acceptance Criteria (Not explicitly stated as "acceptance criteria" but implied by comparison to predicates and clinical study results) | Reported Device Performance (Masimo W1 with AFib Classification Feature) |
|---|---|---|
| Atrial Fibrillation (AFib) Classification | ||
| Sensitivity | Comparable to or better than predicate devices (Withing Scan Monitor: 96.3%; Samsung ECG Monitor: 98.1%) | 99.3% [96.3%, 100%] |
| Specificity (Sinus Rhythm) | Comparable to or better than predicate devices (Withing Scan Monitor: 100%; Samsung ECG Monitor: 100%) | 100% [97.8%, 100%] |
| Positive Predictive Value (PPV) | (Not explicitly compared in table, but reported as a key performance metric) | 100% [97.5%, 100%] |
| Unclassified Rate | (Not explicitly compared in table) | 5.0% |
| Noise Rate | (Not explicitly compared in table) | 1.7% |
| ECG Waveform Quality Analysis | ||
| Qualitative Agreement (with 12-lead ECG Lead I) | High agreement by qualified clinicians | 98% [96% - 98%] |
| Quantitative Similarity (Key ECG features like QRS amplitude, QRS width) | Similar to Lead I of a gold-standard 12-lead ECG reference | Similar to Lead I of a gold-standard 12-lead ECG reference |
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
(260 days)
The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician.
Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport.
Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.
The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly.
The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.
The provided text does not contain detailed acceptance criteria and the results of a specific study to prove the device meets these criteria. Instead, it lists the standards and guidance documents used for design verification and validation, along with a high-level statement that testing demonstrates the device's safety and effectiveness compared to the predicate.
Therefore, many of the requested details cannot be extracted from the given information.
However, I can provide what is available, noting the limitations.
Missing Information:
- Specific quantitative acceptance criteria for device performance.
- The results of a specific study that quantitatively demonstrates the device meets acceptance criteria.
- Sample size used for a dedicated test set for performance evaluation (only general mention of "validation testing").
- Data provenance for any test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for any test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used for performance assessment.
- Sample size for the training set.
- How ground truth for the training set was established.
Information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria and their corresponding reported performance values are not detailed in the document for HRV measurement accuracy or related metrics, this table cannot be populated as requested. The document primarily focuses on regulatory compliance through adherence to standards and safety/EMC testing, and a functional comparison to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| (e.g., HRV measurement accuracy to within X bpm, etc.) | (e.g., Achieved Y bpm accuracy, etc.) |
| Compliance with IEC 60601-1 (Basic safety and essential performance) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-2-25 (Electrocardiographs specific requirements) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 60601-1-6 (Usability) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 62366-1 (Usability engineering) | Testing was conducted and demonstrates compliance. |
| Compliance with ANSI/AAMI EC57 (Cardiac rhythm and ST-segment measurement algorithms) | Testing was conducted and demonstrates compliance. |
| Compliance with ANSI/AAMI EC53 (ECG trunk cables and patient leadwires) | Testing was conducted and demonstrates compliance. |
| Compliance with ASTM D4169-22 (Performance testing of shipping containers) | Testing was conducted and demonstrates compliance. |
| Compliance with IEC 62304 (Medical device software life-cycle processes) | Testing was conducted and demonstrates compliance. |
| Compliance with FDA Guidance: Content of Premarket Submissions for Device Software Functions | Adhered to the guidance. |
| Compliance with FDA Guidance: Cybersecurity in Medical Devices | Adhered to the guidance. |
| Design Validation against Product Requirements | Design Validation by Design Review was performed and successful. |
| Human Factors and Usability Engineering | Human Factors and Usability Engineering Report was generated and successful. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any performance-specific test set. The document refers generally to "Design validation testing" and "Design verification testing" but does not give sample sizes for subjects or data records.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method for the test set
- Not specified.
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
- Not specified. The CloudHRV™ System calculates HRV indices and displays results, which are "used as an aid by clinicians." It does not appear to be an AI-assisted diagnostic or interpretation tool in the context of human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone algorithm performance for HRV calculation: "The raw cardiac electrical signals are detected...The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV." However, no specific performance metrics (e.g., accuracy, precision) are provided for just the algorithm, nor is a dedicated study described.
7. The type of ground truth used
- Not specified for the performance of the HRV calculation itself. The compliance testing for standards likely uses reference devices or simulated signals as ground truth for ECG parameters.
8. The sample size for the training set
- Not specified.
9. How the ground truth for the training set was established
- Not specified.
Ask a specific question about this device
(200 days)
The Cardiac Workstation is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation.
The Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations for review by the user.
The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation.
The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations.
The CW 5000 and CW 7000 consist of the following:
- An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel.
- Optional Trolley (ordered via a separate part number)
The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.
The Philips Cardiac Workstation 5000 and 7000 are ECG devices designed to acquire, record, display, analyze, and store multi-channel ECG signals for review. The analysis is performed by algorithms providing measurements, data presentations, graphical representations, and interpretations.
The study presented in the provided context for the Cardiac Workstation 5000 and 7000 is a non-clinical bench testing study, primarily focused on demonstrating substantial equivalence to a predicate device (PageWriter TC70 Cardiograph, K210560).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally framed as compliance with harmonized standards and successful completion of various bench tests, aiming to show performance similar to the predicate device. Specific quantitative performance metrics for the standalone algorithm are not detailed in the provided text, as the focus is on overall device equivalence.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Report) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with ANSI/AAMI ES60601-1:2005/A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] (General requirements for basic safety and essential performance). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all safety...tests to demonstrate compliance with the harmonized standards..." "The safety classification of both subject and predicate device (K210560) is class I, with CF type of applied part." |
| Electromagnetic Compatibility (EMC) | Compliance with ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] (EMC requirements and tests). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...electromagnetic compatibility...tests to demonstrate compliance with the harmonized standards..." "The EMC emission classification is Group I, Class B." |
| Electrocardiograph Specific Performance | Compliance with ANSI AAMI IEC 60601-2-25:2011/(R)2016 (Particular requirements for basic safety and essential performance of electrocardiographs). | "Compared to the predicate device (K210560), PageWriter TC70 Cardiograph, the subject CW 5000 and CW 7000 devices provide similar performance on ECG acquisition of up to 18 leads, algorithm interpretation, display accuracy, and ECG report formats for printing and transmission purposes." Also, improvements: ECG A/D signal processing resolution from 12 to 24 bit, digital data processing rate from 500 to 1000 SPS, ECG signal bandwidth from 0.05Hz |
| Usability | Compliance with IEC 60601-1-6: 2010+A1:2013+A2: 2020 (Usability) and IEC 62366-1: 2015+A1: 2020 (Application of usability engineering to medical devices). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 were evaluated against all applicable external standards and successfully passed all verifications and validations. The results demonstrate that Cardiac Workstation 5000 and Cardiac Workstation 7000 meet the performance claims..." |
| Software Life Cycle Processes | Compliance with ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software - Software life cycle processes). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...software...tests to demonstrate compliance with the harmonized standards..." |
| Cybersecurity | Compliance with relevant cybersecurity risk control standards and best practices (implied by the focus on security enhancements). | "Compared to the predicate device, PageWriter TC70 Cardiograph (K210560), the subject device provides improved cybersecurity risk control. The operating system has been changed from the "end of support" WinCE5/WinCE7 OS to the supported Linux OS. The device supports FIPS 140-2 for data encryption, user authentication, USB disk encryption and digital signature, and supports SMB V2/V3." This improved performance is identical to the reference device, PageWriter TC35 (K221141). |
| Risk Management | Compliance with ISO 14971:2019 (Application of risk management to medical devices). | "Risk management activities have all been applied/conducted for the Cardiac Workstation 5000 and Cardiac Workstation 7000." |
| Wireless Coexistence | Compliance with ANSI C63.27:2021 (Evaluation of Wireless Coexistence) and AAMI TIR69:2017/(R2020) (Risk management of radio-frequency wireless coexistence). | "The subject Cardiac Workstation 5000 and Cardiac Workstation 7000 have passed all...tests to demonstrate compliance with the harmonized standards..." "Compared to the predicate device...the wireless module used for the subject device provides updated compatibility to support communication protocol 802.11 ac (WiFi 5)." The wireless function, specification, transmitting data, and connecting system/application are the same as the reference device, Pagewriter TC35 (K221141). |
| Non-clinical Bench Test Performance | Verification of performance in software, environment, reliability, mechanical, hardware, packaging, human factors and usability performance. Demonstrated performance meets claims and supports substantial equivalence. | "Non-clinical bench testing activities established the performance, functionality, and reliability characteristics of the subject Cardiac Workstation 5000 and Cardiac Workstation 7000. This testing covered verification of performance in the domains of software, environment, reliability, mechanical, hardware, packaging, human factors and usability performance. The Cardiac Workstation 5000 and Cardiac Workstation 7000 were evaluated against all applicable external standards and successfully passed all verifications and validations. The results demonstrate that Cardiac Workstation 5000 and Cardiac Workstation 7000 meet the performance claims and support a determination of substantial equivalence to the predicate PageWriter TC70 Cardiograph (K210560)." |
2. Sample Size for the Test Set and Data Provenance
The document does not detail specific sample sizes for a 'test set' in the traditional sense of a clinical or algorithm performance study. The evidence provided is primarily focused on bench testing against harmonized standards and comparison to a predicate device. Therefore, the "test set" would refer to the tests and evaluations conducted on the devices themselves rather than a dataset of patient ECGs.
The data provenance for any internal testing is not explicitly stated in terms of country of origin or retrospective/prospective nature regarding patient data. However, the harmonized standards (e.g., IEC, ANSI/AAMI, ISO, ASTM) are international or US-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No information is provided about experts establishing ground truth for a test set. This type of information would typically be present in a clinical or algorithm validation study. Since this is a substantial equivalence submission based on non-clinical bench testing, the ground truth refers to compliance with established technical specifications and standards rather than clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as the provided document describes non-clinical bench testing and compliance with standards, not a study involving expert adjudication of clinical outcomes.
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 comparative effectiveness study was done. The document explicitly states: "The Cardiac Workstation 5000 and Cardiac Workstation 7000, like the predicate device (K210560), did not require clinical studies to demonstrate substantial equivalence." The algorithm ("Philips DXL ECG Algorithm", K132068) is mentioned as previously cleared. This submission focuses on the hardware device's equivalence and updated features, not new claims about AI performance or human-AI interaction.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The document states that the devices use the "clinically proven Philips DXL ECG Algorithm (K132068)" or "same cleared ECG algorithm (PH110C) for ECG measurement and interpretation." This implies that the algorithm's standalone performance was likely established in its original K132068 submission. This current submission for the Cardiac Workstation 5000/7000 leverages that existing clearance and does not provide new standalone algorithm performance data. The mention of the algorithm being "advisory basis only" and requiring "a qualified physician to over-read and validate (or change) the computer-generated ECG interpretation" confirms it is not intended for standalone diagnostic use without human oversight.
7. The Type of Ground Truth Used
For the specific non-clinical bench tests described in this document, the "ground truth" is compliance with harmonized technical standards and internal specifications. For the underlying DXL ECG algorithm, its original clearance (K132068) would have established its ground truth, likely using expert consensus ECG interpretations, and potentially clinical outcomes or pathology, but details are not provided in this document.
8. The Sample Size for the Training Set
The document does not provide a sample size for the training set. This information would pertain to the development of the DXL ECG algorithm, which was already cleared under K132068. This submission is for the Cardiac Workstation devices incorporating the already cleared algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. It would have been part of the original submission for the Philips DXL ECG Algorithm (K132068).
Ask a specific question about this device
(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).
Ask a specific question about this device
(336 days)
The DeepRhythm Platform is intended for use by qualified healthcare professionals for the assessment of arthythmias using ECG data in adult patients.
The product supports downloading and analyzing data recorded in compatible formats from 1-channel and 2-channel ambulatory ECG recording devices used for the arthythmia diagnostics such as Holter, event recorder or other similar devices when retrospective assessment of the rhythm is necessary.
The DeepRhythm Platform is intended for the storage, analysis, visualization, review and reporting of arthythmias. The DeepRhythm Platform utilizes DeepRhythmAl (FDA-cleared device) for QRS and arrhythmia detection on the received signal. The DeepRhythm Platform provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis, for both symptomatic and asymptomatic events.
The DeepRhythm Platform is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices. The product can be integrated with computerized ECG monitoring devices compatible with DeepRhythmAI.
The DeepRhythm Platform interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
The DeepRhythm Platform system is a cloud-based software with microservice architecture and browser-based user interface. It provides arrhythmia diagnosis process and monitoring session management capabilities.
The DeepRhythm Platform's functionality consists of:
- enrolling a patient for an ECG monitoring session in a medical facility (performed . by Healthcare Professionals users),
- receiving the signal from a compatible monitoring device worn by the patient, .
- using an external AI service for signal analysis and classification (not a part of the . subject device),
- processing signal and annotations received from the external Al service, including . statistics computation,
- · reviewing the signal and annotations by an ECG Technician user,
- generating and publishing a report for a single ECG episode (Urgent report) and . for the entire monitoring session (End of Study report), performed by an ECG Technician user,
- reviewing a published report back at the medical facility that ordered the monitoring . session in the first place (performed by a Physician user).
The provided text does not contain detailed acceptance criteria or a comprehensive study report proving the device meets specific performance criteria. It primarily focuses on the regulatory submission information for FDA 510(k) clearance, asserting substantial equivalence to a predicate device.
Therefore, I cannot populate all the requested information. However, I can extract what is available and note the missing information.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics. It generally states that "All necessary testing was conducted on the DeepRhythm Platform to support a determination of substantial equivalence to the predicate device. Test results confirm that DeepRhythm Platform meets its intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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 information is not provided in the document. The document mentions that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This suggests that the AI component's ground truth establishment might have been part of its own prior clearance, but details for the DeepRhythm Platform's specific testing are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The DeepRhythm Platform's role is described as "interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only." This suggests it's an assistive tool, but a comparative effectiveness study with human readers is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "DeepRhythm Platform utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This implies that the core algorithmic performance for detection is handled by the pre-cleared DeepRhythmAI. The DeepRhythm Platform "provides further ECG signal annotations processing on a beat-by-beat basis, heart rate measurement and rhythm analysis," and processes statistics from DeepRhythmAI. However, specific standalone performance metrics for the DeepRhythm Platform's unique contributions (beyond DeepRhythmAI) are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for this specific submission's testing is not explicitly stated. Given that it leverages a previously cleared AI for detection, the ground truth for the DeepRhythmAI algorithm itself would have been established during its clearance, likely through expert consensus with ECG interpretation. For the DeepRhythm Platform's own capabilities (processing, visualization, reporting), it would likely involve verification against established ECG processing standards and internal validation, but the ground truth method is not described.
8. The sample size for the training set
The document states that the DeepRhythm Platform "utilizes DeepRhythmAI (FDA-cleared device) for QRS and arrhythmia detection on the received signal." This means the training of the core AI algorithm (DeepRhythmAI) would have been done prior to this submission as part of its own clearance. The sample size for the training of DeepRhythmAI is not provided in this document.
9. How the ground truth for the training set was established
As in point 8, the ground truth for the DeepRhythmAI algorithm's training would have been established during its separate FDA clearance. Details on this ground truth establishment are not provided in this document.
Ask a specific question about this device
Page 1 of 31