Search Results

The CSF-4 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-4 also measures, records and displays pulse rate.

The CSF-4 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-4 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-4 is a prescription device and should be used under the care of a physician. CSF-4 does not provide any alarms. It is not intended for pediatric use or use in critical care settings. The device is not intended to provide outputs during periods of motion.

The CSF-4 is a non-invasive system comprised of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2), as well as measuring pulse rate using photoplethysmography (PPG).

CSF-4 is a single-patient use, wearable monitoring device that collects intermittent data of physiological parameters, when little to no motion is detected.

The CSF-4 is comprised of 3 main components;

• 1. CS Watch 3 with CSF-4 Watch firmware ("Watch"): The CS Watch 3 is a wrist worn device embedded with non-invasive sensors. The watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in nonvolatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends real-time raw data signals to the Mobile App.
• 2. CSF-4 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The mobile app communicates with the watch via BLE and to the Cloud App via HTTPS, thus acting as the watch gateway to the cloud application. The Mobile App caches the processed data from the watch and transfers it to the cloud application. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications.
• 3. CSF-4 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.

The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the CardiacSense CSF-4 device. The information is extracted from the 510(k) Summary.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL TESTING" and "SUMMARY OF CLINICAL TESTING" sections:

Note: For QRS detection and HR accuracy, the "acceptance criteria" are implied by the reported performance relative to the standards. For SpO2, it's explicitly linked to the ISO standard. For overall ECG and PPG validation, specific numerical criteria were not explicitly stated as "acceptance criteria" but rather as "performance."

2. Sample sizes used for the test set and the data provenance

• QRS Algorithm (Bench Testing): Evaluated against three databases: MIT-BIH Arrhythmia, AHA, and MIT-BIH Noise Stress. The specific sample sizes (number of recordings/patients) for each database are not provided in this document, only that the evaluation was "per recording and per database."
• Pulse Oximeter Testing:
  • Sample Size: n=234 samples.
  • Data Provenance: Conducted at the Hypoxia Research Laboratory, Department of Anesthesia Perioperative Care, University of California at San Francisco (UCSF). This is a prospective clinical study based on the context.
• ECG and PPG Validation:
  • Sample Size: Not explicitly stated, but the study was conducted at Fairview Research Center of the University of Minnesota. This was part of a previous submission (CSF-3) and was "reviewed and accepted by the Agency." This suggests it was likely a prospective clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for any of the tests.

• For QRS algorithm testing, the ground truth for the MIT-BIH Arrhythmia and AHA databases is inherently part of those standardized, expert-annotated datasets.
• For Pulse Oximeter Testing, the ISO 80601-2-61:2017 standard typically specifies requirements for a reference oximeter and a clinical study setup, implying a highly controlled environment with medical professionals overseeing the reference measurements, but specific expert involvement for ground truth adjudication is not detailed here.

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

The document does not specify any adjudication methods (like 2+1 or 3+1) used for establishing ground truth for the test sets.

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 mentions that the ECG signal is for "manual interpretation of heart rate." However, there is no mention of an MRMC comparative effectiveness study, nor any data on how human readers improve with AI vs. without AI assistance. The testing focuses on the device's standalone performance.

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

Yes, standalone performance was assessed for the following:

• QRS Algorithm Performance: Evaluated against standardized databases (MIT-BIH Arrhythmia, AHA, MIT-BIH Noise Stress) - this is algorithm-only performance.
• Pulse Oximeter Testing: The device's SpO2 accuracy was validated against reference measurements, indicating standalone performance.
• ECG and PPG Validation: The reported sensitivity and false detection rates for ECG and PPG suggest standalone algorithmic performance.

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

• QRS Algorithm: The ground truth for the MIT-BIH Arrhythmia and AHA databases is typically derived from expert-annotated ECG waveforms.
• Pulse Oximeter Testing: The ground truth for SpO2 measurements typically comes from a reference oximeter or blood gas analyzer in a controlled clinical setting, as dictated by the ISO 80601-2-61:2017 standard.
• ECG and PPG Validation: While not explicitly stated, clinical validation of ECG and PPG typically involves comparison to a gold standard, which for ECG could be a 12-lead ECG interpreted by cardiologists, and for PPG related to a reference heart rate/pulse measurement.

8. The sample size for the training set

The document does not provide any information regarding the training set size for the algorithms within the CSF-4 device. It focuses solely on the validation/test procedures and results.

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

Since information on the training set is not provided, details on how its ground truth was established are also not available in the provided text.

Ask a specific question about this device

The MedWand™ Device, in combination with the MedWand™ Software Application installed on an attached mobile device or computing system, is an intermittent vital sign measuring and examination system intended to collect, record, and display the following information:

• · Oxygen saturation (SpO2),
• · Pulse rate (PR),
• · Infrared body temperature (TEMP)
• · Amplified auscultation sounds filtered for heart, lungs, and abdomen (STETH)
• · Photographs of areas needing assessment (CAMERA)

The device is intended for use by adult lay users independently or guided by a health care professional (HCP) in home and non-acute clinical environments.

The MedWand™ Device is intended for use by trained adults only who can use smart phones, tablets, or computers proficiently.

Collected information is not intended for self-diagnosis. Interpretation and assessment of results should be performed by an HCP. Collected information can be provided to a HCP when used as a standalone device.

Additionally, the MedWand™ Device can integrate with external data communications systems (not part of the MedWand™ Device) through a programming interface. This integration will facilitate interactions between the lay user and HCP for telemedicine. The device is intended for spot-checking and does not have continuous monitoring capability or alarm features.

The MedWand™ Device is a handheld telemedicine device that allows measurement of SpO2. pulse rate, and stethoscope along with a camera. The device is intended to be used by lay people or clinical personnel. The patient applies their finger to the sensor on the top of the device designed for measuring SpO2 and pulse rate. The thermometer is a non-contact IR thermometer that is pointed to the patient's forehead. The camera can be pointed to the particular body part at the (remote) Health Care Professional's (HCP) direction. The stethoscope is contacted directly to the patient's chest or abdomen to provide auscultation sounds to the (remote) HCP.

The MedWand™ Device works as part of the MedWand™ Ecosystem. The MedWand™ Ecosystem consists for following elements:

• 1. MedWand™ Device including its embedded firmware This device is provided to the patient or other user who is physically present with the patient.
• 2. USB-C cable provided with the device. This cable physically connects the MedWand™ Device to the mobile device or computing platform to provide power, communications, and control for the MedWand™ Device
• 3. Client App Software Proprietary software that is provided to the patient or user to run on their mobile device or computing platform (MCP). This software is available for both Windows-based and Android-based devices. This software supports the local operation of the MedWand™ Device and the use of the device in the context of a telemedicine system. This software contains the user interface to the MedWand™ Device. This software provides the user with the concept of a session in which the user activates one or more sensors, collects readings for temperature and pulse oximeter, photos from the camera, and recordings from the stethoscope.
• 4. Device Communications Module (DCM) The DCM runs on the MCP incorporated as a library in the Client App. The DCM manages the serial communications between the MedWand™ Device and MCP. The DCM is also known as the Software Developer's Kit (SDK), as it provides a controlled programming interface to enable integration with thirdparty telemedicine systems.
• 5. A mobile device (e.g., laptop, tablet or smartphone) or computing platform (laptop or computer) (collectively Mobile Computing Platform (MCP)) – The MCP is supplied by the patient or user, not by MedWand. The Client App proprietary software runs the MCP. The MCP is not part of the medical device.
• 6. A clinician receiving platform located in a clinical environment (e.g., a PC at the clinic, not supplied by MedWand and not part of the medical device). As described in the cited FDA guidance, this platform and any clinician interface are not part of the medical device.
• 7. Commercial Telemedicine systems provides real-time voice and video communications between the HCP and the MedWand™ Device user (as patient) in a virtual live visit. These external software systems would be classified as Medical Device Data Systems, which FDA no longer considers medical devices.

Here's a breakdown of the acceptance criteria and study information for the MedWand™ Device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides performance details for individual functions (SpO2, Pulse Rate, Temperature) but explicitly states that the MedWand™ Device met "the more stringent required acceptance criteria from the FDA guidance for reflectance pulse oximeters" and that thermometer results are "similar to other published temperature data for IR thermometers." The exact numerical acceptance criteria from the FDA guidance or standards are not fully specified for all metrics in this document, but the device's performance against them is confirmed.

2. Sample Sizes and Data Provenance

For SpO2 Accuracy Study (Controlled Hypoxia):

• Sample Size: 14 healthy volunteer subjects
• Test Set Description: Ages 21-40; 6/14 male (42%); range of ethnicities, including at least 28% (4/14) with dark skin tones.
• Data Provenance: Not explicitly stated, but the nature of a "controlled hypoxia" study strongly suggests prospective clinical data collected specifically for this validation in a controlled environment. Country of origin not specified.

For Thermometer & Additional SpO2/PR Clinical Agreement Study:

• Sample Size: 158 subjects
• Test Set Description: Patients from an outpatient health clinic; ages 18-81 (median 35, mean 37); 64/158 male (41%); skin tones 1-6 (dark) with median 2; 59/158 (37%) presented febrile symptoms.
• Data Provenance: Not explicitly stated, but implies prospective clinical data collected from an outpatient health clinic. Country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the test sets. However, it references established methods:

• For SpO2: Arterial blood samples were measured for SaO2 on a cooximeter, which is a highly accurate reference method. This implicitly relies on the calibration and proper operation of the cooximeter.
• For Temperature: A "well-established reference clinical thermometer" was used, specifically mentioning the Exergen TAT thermometer (K011291) as a reference predicate in the comparison table, which uses rectal as the reference body site.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test sets. The ground truth was established using objective, established reference methods (cooximetry for SpO2, reference clinical thermometer for temperature).

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

No MRMC comparative effectiveness study is mentioned. The studies described are device performance studies against reference standards.

6. Standalone Performance Study

Yes, the clinical studies evaluate the performance of the MedWand™ Device in a standalone manner against established reference methods. For example, the SpO2 data from the MedWand™ pulse oximeter was compared directly to SaO2 results from a cooximeter. Similarly, MedWand™ temperature readings were compared to a reference clinical thermometer.

7. Type of Ground Truth Used

• For SpO2: Physiological ground truth established by arterial blood gas analysis (SaO2 measured by cooximeter).
• For Temperature: Physiological ground truth established by a reference clinical thermometer (Exergen TAT thermometer, K011291, with rectal as the reference body site).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size for the device's algorithms. The clinical studies described are explicitly for validation of the finished device.

9. How Ground Truth for Training Set Was Established

Since a separate "training set" with ground truth establishment is not described in the context of machine learning (which might use such a set for model development), this information is not provided. The performance data presented is from validation studies comparing the device to accepted medical reference standards.

Ask a specific question about this device