Search Results

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.

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.

Ask a specific question about this device

Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.

The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.

This document describes the Ergoline Ergoselect / GE device, an exerciser for physiotherapy. Since this is a very basic device, the provided information does not contain the typical sections found in a submission for an AI/ML-powered medical device regarding acceptance criteria and detailed study results. The content focuses on demonstrating substantial equivalence to a predicate device and compliance with general safety and performance standards.

Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is a physical exerciser, not an AI/ML diagnostic or prognostic device that uses a "test set" of patient data in the typical sense. The "performance data" refers to non-clinical performance and compliance with standards rather than clinical trial data on patient outcomes for an algorithm. The text states "All models that are covered by this 510(k) premarket notification have been on the market in Europe for years with no device failures." suggesting real-world usage experience, but it doesn't specify a sample size or provenance for this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of expert consensus is not relevant for this type of medical device as it does not perform diagnostic interpretations.

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

Not applicable, as there is no "test set" in the context of diagnostic performance requiring expert adjudication.

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, as this device is an exerciser, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm-only device.

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

Not applicable. The "ground truth" for this device's performance would be its adherence to established engineering, safety, and performance standards for exercise equipment, and its ability to function reliably for its indicated uses (physiotherapy, muscle redevelopment, obesity adjunct treatment).

8. The sample size for the training set

Not applicable. This device does not have an AI/ML component that requires a "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

Ask a specific question about this device

Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.

The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.

The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.

The provided text is a 510(k) summary for the Ergoline Ergoselect 100 K/P and Ergoselect 200 K/P ergometers. It states that the device is deemed "substantially equivalent" to a predicate device (K851097), which means it has similar intended use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.

Crucially, this type of submission (510(k)) for substantial equivalence typically does not involve a new stand-alone clinical study with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies of the kind you've asked for. Instead, the manufacturer demonstrates that their device is as safe and effective as a legally marketed predicate device.

Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. I will answer the applicable parts and indicate where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission does not present a de novo clinical study with specific acceptance criteria and detailed performance metrics as you typically find for novel devices. Instead, a substantial equivalence determination is made against a predicate device. The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this 510(k) submission. The submission relies on a comparison to a predicate device, not a new clinical study with a test set of patients or data.

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

• Not applicable for this 510(k) submission. No independent expert review of a new test set was conducted for this substantial equivalence determination.

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

• Not applicable for this 510(k) submission. No test set requiring adjudication was used.

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 for this device (ergometer) or this type of submission (510(k) for substantial equivalence). This device is an ergometer, not an AI-assisted diagnostic tool.

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

• Not applicable for this device (ergometer) or this type of submission. This device is an ergometer; it does not involve algorithms for standalone performance measurement in the context of diagnostic AI.

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

• The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (K851097). The new device is compared against this predicate.

8. The sample size for the training set

• Not applicable for this 510(k) submission. This device is an ergometer, not an AI-driven system that requires a "training set" in the context of machine learning.

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

• Not applicable for this 510(k) submission. As there is no training set for an AI algorithm here, no ground truth needed to be established in that manner. The "ground truth" for the submission is the regulatory acceptance of the predicate device.

Ask a specific question about this device