(19 days)
The Health Monitoring Kit (HMK) is a non-invasive, spot- measuring device used to measure blood pressure, heart rate, oxygen saturation levels, pulse rate, and heart and lung sounds.
The March Healthcare Health Monitoring Kit (HMK) is a portable medical device equipped with a built-in blood pressure monitor. pulse oximeter, and electronic stethoscope intended for spot-checking the basic vital signs of pediatric patients aged three and older and adult patients under the care of a physician in both clinical and home environments. The HMK can be used as a stand-alone unit or it can be connected to a host using a standard Bluetooth® wireless interface or wired universal serial bus (USB) interface to support remote control of the HMK and audio and data transmission in telehealth applications.
In both stand-alone and remote telehealth applications. the user can spot-check the following vital signs with the blood pressure monitor and pulse oximeter: heart rate and svstolic and diastolic blood pressure. and functional blood oxygen saturation and pulse rate. In remote telehealth applications when the HMK is interfaced with a host, the electronic stethoscope transmits heart and lung sounds via the host to a health care professional at a remote computer. The data from the HMK can be viewed in one of two wavs: on the built-in HMK liquid crystal display (LCD) or from a remote computer connected to a host.
The HMK blood pressure monitor uses the non-invasive, oscillometric, step-wise deflation method to measure heart rate and systolic and diastolic blood pressure. The noninvasive pulse oximeter measures functional blood oxygen saturation and pulse rate using a photodetector and a red and infrared light source to measure the absorption of red and infrared (IR) light passed through the tissuc and arterial hemoglobin. The electronic stethoscope uses a microphone within the chestpiece. bchind a diaphragm. The microphone converts the sound in the chestpiece to an clectronic signal for amplification and transmission to a health care professional at a remote computer via the host.
The HMK does not store physiological data in memory. When using the HMK as a standalone unit. the user must manually record the results displayed on the LCD. However. when the HMK is interfaced with a host, the host may store the audio and physiological data in a database for remote access by authorized clinicians.
The HMK is powered with either a Sealed Lead Acid (SLA) battery or a Medical Grade IEC 60601-1 compliant AC adapter. The AC adapter is also used to charge the SLA battery.
The HMK has only two external inputs: AC adapter input and universal serial bus (USB) input. The user connects the AC adapter to the DC power plug socket when the battery needs charging. In addition, the user can connect the HMK to the host using the Type B USB input as a wired alternative to the wireless Bluetooth interface.
The HMK is for sale by or on the order of a physician.
The March Healthcare Health Monitoring Kit (HMK) is a portable medical device equipped with a built-in blood pressure monitor, pulse oximeter, and electronic stethoscope.
Here is a summary of acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of numerical acceptance criteria for the HMK's performance. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The performance is reported as meeting the specifications of these predicates.
| Component | Acceptance Criteria (Equivalent to) | Reported Device Performance |
|---|---|---|
| Blood Pressure Monitor | Welch Allyn 52000 Vital Signs Monitor (K951193) specifications for Non-Invasive Blood Pressure (NIBP) measurement. | "The Non-Invasive Blood Pressure measurement specifications and performance are equivalent to the Welch Allyn 52000 Vital Signs Monitor (K951193). The HMK and the Welch Allyn 52000 Vital Signs Monitor use a CAS Medical OEM NIBP module that is similar in design." Additionally, "CAS NE NIBP performance tests were performed to show substantial equivalence to the Welch Allyn 52000 VSM." |
| Pulse Oximeter (SpO2) | Welch Allyn 52000 Vital Signs Monitor (K951193) specifications for SpO2 measurement. | "The HMK SpO2 measurement and performance specifications are equivalent to the Welch Allyn 52000 Vital Signs Monitor (K951193) because both units use Nonin OEM pulse oximetry technology." Additionally, "Nonin SpO2 performance tests were performed to show substantial equivalence to the Welch Allyn 52000 VSM." |
| Electronic Stethoscope | Cardionics E-Scope Electronic Stethoscope Model 7187-120 (K961301) specifications for heart and lung sound capture and transmission. | "The heart and lung sound specifications and performance are derived from the Cardionics stethoscope (K961301)." "Comparative testing was performed between the HMK and the E-Scope Electronic Stethoscope Model 7187-120 for similar frequency response." The comparison testing demonstrated that "the HMK and the Cardionics E-Scope perform equivalently." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific numerical sample sizes for the test sets used in the comparative performance testing. It states:
- "Comparative testing between the March Healthcare Health Monitoring Kit and the Welch Allyn 52000 Vital Signs Monitor (K951193) was performed to validate the functional performance of the March Healthcare HMK. In particular, CAS NE NIBP and Nonin SpO2 performance tests were performed to show substantial equivalence to the Welch Allyn 52000 VSM."
- "Comparative testing was performed between the HMK and the E-Scope Electronic Stethoscope Model 7187-120 for similar frequency response."
- The data provenance is not explicitly stated as "retrospective" or "prospective" but implies prospective testing performed for the purpose of demonstrating equivalence, likely in a controlled environment given the nature of the device and testing described. The submission is made by a Canadian company (March Healthcare Corporation, Ottawa, Ontario, Canada).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for the performance testing. The strategy relies on comparing the HMK's performance to existing FDA-approved devices, rather than establishing a completely new ground truth with human experts for each measurement. The predicate devices themselves would have undergone such validation during their own approval processes.
4. Adjudication Method for the Test Set
No adjudication method is described for the test set. Given the nature of the device (a vital signs monitor measuring objective physiological parameters) and the reliance on comparison with predicate devices, an adjudication method for human interpretation is not applicable in the same way it would be for diagnostic imaging or subjective assessments. The "ground truth" for the HMK's measurements is their agreement with the measurements from the predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The HMK is a device that directly measures vital signs. MRMC studies are typically performed for medical imaging or diagnostic tools where human interpretation of data (e.g., images) is a critical part of the diagnostic process, and the AI's role is to assist or augment that human interpretation. The HMK's function is to provide raw measurement data (blood pressure, SpO2, heart rate, and sound), not to interpret complex medical images or data that require multiple human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the performance testing described effectively evaluates the standalone performance of the HMK's measurement capabilities. The comparisons are focused on how accurately the HMK's blood pressure, SpO2, and stethoscope components measure vital signs in isolation, relative to the predicate devices. Human interaction for standalone units involves manually recording results, but the measurement itself is algorithmic. For remote telehealth, the device transmits data and audio; the "human-in-the-loop" would be the healthcare professional interpreting the received data, but the HMK's performance being evaluated here is its ability to acquire that data accurately on its own.
7. The Type of Ground Truth Used
The ground truth for the HMK's performance testing is based on comparison to legally marketed and FDA-approved predicate devices:
- Welch Allyn 52000 Vital Signs Monitor (K951193): Used as the reference for blood pressure and SpO2 measurements.
- Cardionics E-Scope Electronic Stethoscope Model 7187-120 (K961301): Used as the reference for heart and lung sound frequency response.
The assumption is that these predicate devices are themselves accurate against conventionally accepted medical standards or gold standards.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. The HMK incorporates OEM modules (Nonin's Ipod/Xpod pulse oximetry technology and CAS Medical's NE NIBP module) and Cardionics' networked electronic stethoscope technology. These modules would have their own internal validation and calibration procedures, which might involve large datasets, but the document doesn't provide details on these. The HMK's own "training" (if interpreted as development and internal testing) is not specified with a sample size; rather, its performance is demonstrated through comparison to established devices.
9. How the Ground Truth for the Training Set Was Established
As no "training set" in the AI sense is explicitly mentioned for the HMK itself (as it uses existing OEM modules), the method for establishing ground truth for such a set is not detailed. For the OEM modules, their ground truth would have been established during their own development and regulatory approval processes, likely through extensive clinical validation against direct physiological measurements and established medical standards.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).