(308 days)
The ers2 – ergoline Rehabilitation System is a device for recording of a single-channel, bipolar surface ECG (frontal plane) acquired with two ECG electrodes. The ECG is transmitted to the ers2 software where it is processed for heartrate calculation, displayed for visual QRS complex assessment and to control the training load for a patient´s rehabilitation or preventive training activities.
The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp).
The signal is acquired on the intact skin of adult patients.
The medical device is intended for use in professional healthcare Institutions for inpatient and outpatient care.
The Ergoline Rehabilitation System 2 consists of a) software (ers2) and b) hardware (ers2 1CH ECG Telemetry system).
a) The software system runs on a PC and is used by therapists to monitor, control and document the training sessions of rehabilitation patients (e.g. in endurance and strength training), whereby the patient can train on different devices or free without the support of devices. Free training can, for example, be performed on strength training equipment or through gymnastic exercises.
The central component of the ers2 system is a PC with an MS Windows operating system and special software which runs the training programs. The training ergometers are connected to the PC system via control lines or a WiFi interface. All data are shown on one to three 22-inch TFT monitors; up to eight patients can be displayed and supervised on each monitor. The ers2 software receives the patient's physiological parameters from the ers2 1CH ECG Telemetry System and uses them for display on the monitor as well as to control the training devices.
Data are transferred between the wireless ergoline ECG transmitter and PC via Bluetooth©.
b) Via the applied part, the ers2 1CH ECG Transmitter acquires a single-channel, bipolar raw ECG signal and sends it to a medical application software or other ME equipment by radio transmission.
The ers2 1CH ECG transmitter is an ME device powered from integrated, exchangeable, rechargeable batteries
These are the components of the ers2 1CH ECG Telemetry system:
. ers2 1CH ECG Transmitter consisting of enclosure, ECG amplifier, radio transmission module, micro-controller with firmware and device connection of the ECG adapter, is worn on the body near the heart and affixed to the ETS1 adapter no skin contact, accessible part, type CF.
. The ers2 1CH ECG adapter (applied part, ECG patient connection) with device socket for connection to the ECG transmitter and device socket for connection to the patient connection (ECG electrode), is worn on the body near the heart, type CF.
. ers2 ECG receiver, receives the ECG signals transmitted by radio. Permanently connected to USB port of a Windows PC. Operated outside patient environment, accessible part, protection class II.
The provided document is a 510(k) summary for the ers2 - ergoline Rehabilitation System. It details the device's intended use, comparison with a predicate device, and compliance with various standards. However, it does not contain information about the performance evaluation of the device in terms of clinical accuracy or a comparative effectiveness study with human readers (MRMC study). The "Performance Testing" section primarily focuses on:
- Electrical Safety and Electromagnetic Compatibility: Compliance with recognized standards.
- Software and System Validation: Verification and validation of firmware and software according to IEC 62304.
- Usability Validation: Confirmation that the device meets its intended use, considering human factors.
Therefore, many of the specific details requested regarding acceptance criteria for clinical performance, sample sizes for test and training sets, expert involvement, and ground truth establishment are not present in this document. The document describes compliance with engineering standards rather than a clinical performance study measuring diagnostic or therapeutic accuracy.
Given the available information, I can only provide details based on the engineering and regulatory compliance aspects described:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for clinical performance (e.g., accuracy of heart rate calculation, QRS complex assessment). Instead, it lists technical specifications and compliance with standards.
| Acceptance Criteria (related to technical specifications/standards) | Reported Device Performance (from "Predicate Device Comparison" section) |
|---|---|
| Regulation Number: 890.2910 | In compliance |
| Product Code: DRG | In compliance |
| Transmission Signal: Radiofrequency | Radiofrequency (similar to predicate) |
| Transmission Equipment: Telemetry transmitter and receiver | Telemetry transmitter and receiver (similar to predicate) |
| Frequency response: within range | 0.05 – 125 Hz (similar to predicate, 0.05 – 100 Hz) |
| Dynamic Range: within range | ± 6 mV (similar to predicate, ± 5 mV) |
| Rejection Ratio: > 80 dB | > 80 dB (similar to predicate, 80 dB) |
| Defibrillation Recovery: Within 8 seconds | Within 5 seconds (similar to predicate) |
| Max distance: at least 100 feet | 164 feet (different from predicate, 100 feet) |
| Compliance with 21 CFR 898 (Mandatory since May 9, 2000) | Yes (similar to predicate) |
| Electrical Safety | Tested and in compliance with recognized standards |
| Electromagnetic Compatibility (EMC) | Tested and in compliance with recognized standards |
| Software Validation (IEC 62304) | Verified and validated, met software system requirements |
| Usability Validation | Validated to confirm device meets intended use |
2. Sample size used for the test set and the data provenance
Not applicable/Not mentioned. The document primarily discusses technical compliance and usability validation, not the performance against a clinical test set of ECGs. No specific data provenance (country, retrospective/prospective) for a clinical performance test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not mentioned. The device's purpose is for heart rate calculation and visual QRS complex assessment, not for interpreting complex cardiac conditions or diagnoses. Therefore, the concept of "ground truth" derived from expert consensus for diagnostic purposes is not addressed in this filing. The "ground truth" implicitly refers to the accuracy of the physiological signal acquisition and heart rate calculation as validated through engineering and software testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. This typically relates to studies involving human interpretation or complex image analysis, which is not the focus of the performance testing described here.
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 applicable/Not mentioned. The device is a "Radiofrequency Physiological Signal Transmitter and Receiver" intended for heart rate calculation and visual QRS complex assessment to control training load. It is explicitly stated: "The ers2 system is not intended to be used to detect or diagnose cardiac conditions (e.g. arrhythmias, ST-elevation, etc. pp)." Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's intended use and is not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document implies "standalone" performance in terms of the technical capabilities and software validation. The "ers2 software" processes the ECG for heart rate calculation and display. The "Software and System validation" section states that the software "met the software system requirements." This indicates an assessment of the algorithm's functionality, but no quantitative performance metric (e.g., accuracy against a true heart rate benchmark) is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance aspects (e.g., software validation, heart rate calculation), the implied "ground truth" would be engineering benchmarks, known physiological signals, or predefined system requirements for the software's functionality. It does not involve expert consensus, pathology, or outcomes data, as those are typically for diagnostic or prognostic devices.
8. The sample size for the training set
Not applicable/Not mentioned. This document pertains to regulatory submission for a medical device (transmitting and receiving physiological signals), not the development or training of an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable/Not mentioned for the same reason as #8.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).