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510(k) Data Aggregation
(346 days)
HMicro, Inc.
The LifeSignals WiPatch & WiApp system is intended for spot check and short-term monitoring of ECG & heart rate of patients at rest or patients who can be transported within the range of the antenna network. The WiPatch & WiApp system has visual and audio alarms to alert clinical personnel when heart rate falls outside the set limits. The device is intended for use on general care patients of 18 years or older. The device is not intended for use on critical care patients.
The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.
The LifeSignals WiPatch & WiApp System consists of the 1) LifeSignals WiPatch 2) LifeSignals WiApp System and 3) Access Point as described below.
The LifeSignals WiPatch:
- is a wireless ECG patch that--when attached to the upper left chest of a patient -continuously acquires physiological signals and transmits these signals wirelessly to any compatible receiver.
- is disposable and integrated with four adhesive electrodes for body interface.
- acquires two channels of electrocardiograph (ECG-A and ECG-B) signals
- transmits acquired signals after initial pre-processing to a compatible receiver wirelessly using the 802.11b communication protocol (2.4 GHz).
- is powered by two-coin cell batteries (zinc air) with an operating life up to 72 hours.
- has an integrated switch to power it on, and has bi-color LED indicators to indicate the communication status with the receiver.
The LifeSignals WiApp System:
- consists of a LifeSignals WiApp Software App (WiApp SW), and a compatible commercial iOS device (iPad, iPad 2, iPad Air or iPad Air 2)
- software, when installed on a compatible hardware, establishes a connection to any one of the LifeSignals WiPatches connected to the same wireless network/Access Point through a pairing process.
- receives the transmitted signals from the paired WiPatch wirelessly, processes the signals and displays heart rate, ECG (ECG-A and ECG-B) waveforms on its LCD display for monitoring purposes by trained clinical personnel.
- has audio and visual alarms to alert clinical personnel when heart rate of a patient is outside the set limits, lead off, when the battery is low (either the WiPatch or the WiApp System - iPad), or when there is a loss of communication link between the WiApp System and the WiPatch.
Access Point:
An access point is a commercially available hardware device (a.k.a wireless router) that allows wireless capable devices connect through a wireless standard (e.g. 802.11b). LifeSignals WiPatch and WiApp system communicate through an access point.
The provided text describes the 510(k) summary for the LifeSignals WiPoint Biosensor iOS Receiver App System (LifeSignals WiPatch & WiApp System), which is intended for spot check and short-term monitoring of ECG & heart rate in adult patients (18 years or older) at rest or transportable within an antenna network.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document specifies heart rate accuracy.
| Performance Metric | Acceptance Criteria (from Simulator study Note 1) | Reported Device Performance (from On-body performance study Note 1) |
|---|---|---|
| Heart Rate Accuracy | +/- 3 BPM or better for 100% of data | +/- 3 BPM or better for 97% of data |
Note 1: These values are explicitly stated in the "Table of Comparison" and the subsequent "Note 1" section.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a non-randomized, self-control comparative clinical study" for validating heart rate accuracy and on-body adhesion. However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance
The document details performance testing for the "LifeSignals WiPatch & WiApp System" which includes the "WiPatch" (hardware sensor) and the "WiApp Software App" (algorithm/software). The performance metrics for heart rate accuracy are presented for the overall system, not solely for the algorithm in isolation without human interaction. Therefore, a standalone (algorithm only) performance is not explicitly detailed as such, though the heart rate accuracy is a measurement of the system's output.
7. Type of Ground Truth Used
The document mentions a "Simulator study" and an "on-body performance study" for heart rate accuracy. This implies the ground truth for the simulator study would be from the simulator's known output, and for the on-body study, it would be from a reference device or method used to establish true heart rate during the clinical study. However, the exact nature of this reference method is not explicitly stated (e.g., gold standard ECG, manually counted pulses, etc.).
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set. This is common for 510(k) summaries which focus on validation rather than development.
9. How the Ground Truth for the Training Set Was Established
As no training set sample size is provided, the document similarly does not provide any information on how the ground truth for a training set was established.
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(191 days)
HMICRO, INC.
The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.
The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.
The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.
Here's the information about the acceptance criteria and the study for the HMicro Wired C-Patch Electrode, extracted from the provided text:
Acceptance Criteria and Device Performance Study for HMicro Wired C-Patch Electrode
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to provide usable ECG tracings as often as a commercially available predicate. | 85% (11/13) of volunteer data was similar between the two HMicro Patches (left chest and center chest placements) and the respective control (3M Red Dot electrodes). |
2. Sample size used for the test set and the data provenance
- Sample Size: 15 volunteers (netting usable ECG tracings data from 13 volunteers).
- Data Provenance: The document does not explicitly state the country of origin. It was an engineering study involving volunteers, implying a prospective 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 mention the use of experts to establish a ground truth or their qualifications. The study focused on the usability of data by comparing ECG tracings from the subject device to a predicate device.
4. Adjudication method for the test set
The document does not describe an adjudication method involving experts for the test set. The comparison appears to have been based on similarity of ECG tracings.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an electrode, not an AI-powered diagnostic system, so the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an ECG electrode, not an algorithm. The study evaluated the ability of the electrode to produce usable ECG data.
7. The type of ground truth used
The "ground truth" in this context was established by:
- Comparison to a predicate device: The 3M Red Dot electrodes, a commercially available and legally marketed device, served as the comparative standard.
- Usable ECG tracings: The primary outcome measured was the similarity of the ECG tracings produced by the HMicro C-Patch to those from the predicate device.
8. The sample size for the training set
This is not applicable. The device is hardware (an ECG electrode), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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