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510(k) Data Aggregation
(269 days)
NOVACOR DIV.
The R-Test Evolution is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording.
The R-Test Evolution is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight neck cable which can be worn by the patient unobtrusively and without any discomfort. The R. Test Evolution is connected to the patient by a system of electrodes and the neck cable. Cardiac events are memorized by the R. Test evolution and then transferred by a decoder, the Decotest, to an electrocardiograph or a computer for interpretation: - either directly at the physician's surgery at the following visit, - or by being transmitted telephonically by the patient himself. The R. Test Evolution can also transmit real time ECG recordings by telephone. After making a telephonic or direct transfer, the R. Test Evolution can continue recording any further pathological events which may occur. Using a computer enables you to: - define the conditions and criteria of the recordings to be made by the R. Test Evolution, - to select, organize and store the results of a procedure, and to print them using specific report parameters.
This document does not contain the information required to populate all sections of the requested table and study description. The provided text is a 510(k) summary for the Novacor R.Test Evolution, primarily focusing on general device description, intended use, and substantial equivalence to predicate devices, along with regulatory compliance. It does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth establishment relevant to an AI/algorithm-based device in the way requested.
The device described is an ambulatory ECG recorder, which is a hardware device for recording physiological data, not an AI or software algorithm that interprets data. Therefore, many of the requested fields (like "AI vs without AI assistance," "standalone algorithm performance," "training set sample size," or "adjudication method") are not applicable to the information provided.
However, I can extract the general performance claims and what constitutes "performance standards" based on the provided text.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformity to EN 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | Devices are manufactured according to EN-60-601-1. Testing for conformity to this standard will be completed, reviewed, and approved prior to release. |
| Conformity to EN 60601-1-1 (Collateral standard: Safety requirements for medical electrical systems) | Testing for conformity to this standard will be completed, reviewed, and approved prior to release. |
| Conformity to EN 55011 (Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics – Limits and methods of measurement) | Testing for conformity to this standard will be completed, reviewed, and approved prior to release. |
| Conformity to EN 55082-1 (Electromagnetic compatibility – Generic immunity standard – Part 1: Residential, commercial and light industry) | Testing for conformity to this standard will be completed, reviewed, and approved prior to release. |
| Conformity to IEC 801-2, 3 & 4 (Electromagnetic compatibility standards related to electrostatic discharge, radiated electromagnetic fields, and electrical fast transient/burst immunity) | Testing for conformity to these standards will be completed, reviewed, and approved prior to release. |
| Conformity to 93/42 EEC - European Medical Device Directive | Devices are manufactured according to 93/42 EEC. Testing for conformity to this directive will be completed, reviewed, and approved prior to release. |
| Conformity to EN 46002 / ISO 9002 (Quality assurance standards) | Devices are manufactured according to EN 46002 / ISO 9002. Testing for conformity to these standards will be completed, reviewed, and approved prior to release. |
| Ability to memorize significant pathological events (symptomatic or silent) | The R-Test Evolution is capable of memorizing the most significant pathological events (symptomatic or silent). |
| Ability to monitor continuous heart rate trend | The R-Test Evolution is capable of memorizing the patient's continuous heart rate trend. |
| Recording duration | Capable of up to eight days ambulatory recording. |
| Physical characteristics (weight, comfort) | Unit weighs about 40 grams, includes a lightweight neck cable worn unobtrusively and without discomfort. |
| Data transfer capability | Events can be transferred by a decoder (Decotest) to an electrocardiograph or computer; also capable of transmitting real-time ECG recordings by telephone. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. The document describes a medical device (hardware), not a software algorithm with a "test set" in the context of AI performance evaluation. The "testing" mentioned refers to compliance with safety and electrical standards, not clinical performance data on a specific dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Ground truth, in the context of algorithm performance, is not discussed. The device's function is to record events, not interpret them with an AI. Interpretation requires human experts (physicians) or an electrocardiograph/computer with specific software, which are external to the R-Test Evolution device itself.
4. Adjudication method for the test set
- Not applicable / Not provided.
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 provided. This is not an AI-assisted interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a recorder, not an analytical algorithm.
7. The type of ground truth used
- Not applicable / Not provided. The device records ECG data. The "ground truth" for whether it records accurately would be comparison to a known accurate ECG source or standard, which is part of its regulatory testing for electrical and safety standards, but not in the context of an algorithm's diagnostic performance.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided.
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