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The EKOSCOPE device is intended for medical diagnostic purposes only. It has an electronic stethoscope function with three modes of operation. It also has an electrocardiograph (ECG) function with three modes of operation. The Bell mode processes sounds having a frequency range of 20 Hz -500 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The stethoscope function is used for the detection and amplification of sounds from the heart, lungs, arteries, veins and other internal organs during physical assessment. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.

The ECG mode utilizes one of three modes to detect cardiac electrical activities, specifically from the limb leads, to determine the state of the heart beyond the abilities of a stethoscope. The ECG are detectable by a series of electrodes marked as #1 and #2 as referred in the user manual to user manual to register, record and display the electrical activity of the cardiac cycle in real time. This assessment will allow for the medical professional to then analyze, interpret and diagnose heart rate and rhythm based on recorded limb lead electrocardiogram information. This ECG is not a standard 12-lead ECG and is not suitable for detection of ischemia or infarction. The EKOSCOPE is suitable for adults and pediatrics but not intended for use on infants and in utero. The device is intended for use in hospitals or health care facilities by doctors and trained health care professionals.

The Ekoscope iS100 Device is an electronic stethoscope with 6 leads EKG capability. The electronic microphone can detect sounds between 1.0 Hz to 2KHz from the heart, vessels, lungs and abdomen. The detected sounds are then processed and filtered to reduce ambient noises and transmitted to a removable headset that contains a built in speaker. The sound may also be amplified or attenuated upon demand. The visceral sounds are processed via three stethoscope modes. The first is the Bell Mode. The Bell mode processes sounds having a frequency range of 20 Hz. Secondly, the Diaphragm mode processes sound within a range of 20 Hz to 700 Hz. The third mode is the Diaphragm Plus mode. The Diaphragm Plus Mode processes mechanical heart sounds between 1KHz to 20 KHz. The acquired visceral sounds, along with EKG data, are stored in 30 seconds increments into the device's 2 Gigabyte SD card for playback, delete or upload via USB to a PC using Microsoft Window® version Operating System. The Ekoscope iS100 is powered by a rechargeable Lithium battery. The battery is rechargeable via a micro USB. It has a built-in penlight accessory with adjustable brightness used to visualize pupil, nasal and oral cavity.

The Ekoscope iS 100 also features 6 electrodes. The electrodes are positioned on the head of the device and body of the device. The strategically placed electrodes are used for the detection of 6 channel electrocardiograph (ECG) signals. The ECG signals are from the chest, hands and left leg, via three designated modes: A, B and C. The acquired data is first stored on the Ekoscope iS 100, and can be uploaded to a compatible PC for printing or sending to another location via the internet.

The sample frequency of ECG signal is 200Hz and the bit resolution is 16bit: Adopts 50/60Hz interference suppression. The sample frequency of heart sounds signal is 48kHz and bit resolution is 16bit. Different digital filters will be used in the Bell Mode, Diaphragm Mode and Diaphragm Plus Mode. The device embedded software, proprietary filter and Digital Signal Processing (DSP) technologies, attenuate ambient noises of sounds within a frequency range of 1.0 Hz to 2.0KHz. The sounds are attenuated while preserving native auscultated sounds of interest.

The display speed of the ECG wave and heart sound wave is different on the device's TFT color screen. The ECG wave has two display speed 12.5mm/s and 25mm/s. The display speed of heart sound is 153mm/s. The display range of the ECG wave is selectable and they are 'x0.5', 'x1' and 'x2'. The display range of heart sound wave is not alterable. ECG display is marked with 'ECG' while the Sound Wave display is marked with 'Sound'.

Acceptance Criteria and Device Performance Study for PARACE MD® Ekoscope™ Model iS100

This document outlines the acceptance criteria and the study approach used to demonstrate the substantial equivalence of the PARACE MD® Ekoscope™ Model iS100, an electronic stethoscope with electrocardiograph (ECG) function.

1. Table of Acceptance Criteria and Reported Device Performance

The PARACE MD® Ekoscope™ Model iS100 did not establish specific acceptance criteria for a new clinical study. Instead, its performance was compared to existing predicate devices to demonstrate substantial equivalence. The table below summarizes the key performance features against predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The submission explicitly states that no clinical studies were required to support substantial equivalence. The determination was based on comparisons to predicate devices and adherence to voluntary standards. Therefore, there was no "test set" in the traditional sense of a clinical trial involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no new clinical studies were conducted, there was no separate test set requiring ground truth establishment by experts in the context of a new clinical evaluation. The assessment relied on the established performance characteristics and safety profiles of the predicate devices.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method employed for this purpose.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission indicates that clinical studies were not required for the clearance of this device.

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

The device's functionality is described as a medical device for use by healthcare professionals (human-in-the-loop). While the device incorporates proprietary filters and Digital Signal Processing (DSP) technologies to attenuate ambient noises, this is part of the device's inherent design and not a separate "standalone algorithm only" performance evaluation as might be seen for AI-driven diagnostic software. The focus of the submission was on the overall device's safety and effectiveness in the hands of a user, compared to predicate devices.

7. The Type of Ground Truth Used

The ground truth for demonstrating the device's conformance and substantial equivalence was based on:

• Performance specifications of legally marketed predicate devices. This implies that the 'ground truth' for the expected performance was derived from the established and cleared characteristics of the 3MTM Littmann® Electronic Stethoscope (Models 4100 and 3200) and the Edan SE-3 Electrocardiograph.
• Compliance with international accepted standards on safety and effectiveness. These standards (e.g., IEC 60601-1, IEC 60601-1-2, ANSI/AMMI EC 38, ISO 10993-5, ISO 10993-10) serve as a de facto "ground truth" for general device safety, electromagnetic compatibility, electrical safety, and biocompatibility.

8. The Sample Size for the Training Set

Since the device did not undergo a clinical trial or machine learning development through a 'training set' in the traditional sense, this information is not applicable. The device's design and engineering would have been informed by general medical device design principles and relevant scientific literature, rather than a specific dataset for algorithm training.

9. How the Ground Truth for the Training Set Was Established

As there was no specific training set for a machine learning algorithm, there was no ground truth establishment for such a set. The device's functionality is based on established electronic signal processing and hardware capabilities, with performance benchmarked against equivalent, already-approved medical devices.

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