(121 days)
CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients.
CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool.
CER-S analysis provides indications for evaluation of:
- Patients with rhythm disturbances (cardiac arrhythmias),
- Patients with transient myocardial ischemia,
- Patients with pacemaker (only if pacing detection is available from the input recording),
- Patients needing HRV evaluation.
- Newborn patients limited to QRS detection.
CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER).
Different modules provide:
- ECG Beat detection and classification,
- analysis of ECG rhythm, arrhythmia detection,
- interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows,
- interactive Continuous ECG Viewer,
- interactive display/management of ECG Templates,
- holter-like report for analyzed Continuous ECG records,
- record exportation, in ISHNE format,
- generation of aECG FDA HL7 XML (v. 2).
Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary.
Moreover, CER-S allows the automatic analysis for the following patch location:
- two-electrode patches positioned in the left upper chest area at a roughly inclined angle
- three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle
- three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum
In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.
Here's a breakdown of the acceptance criteria and study information for the CER-S device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) Premarket Notification) does not explicitly state acceptance criteria in terms of specific performance metrics with numerical thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it outlines the scope of performance testing and concludes that the device is "substantially equivalent" to its predicate and meets the relevant standards.
The document focuses on demonstrating that the device adheres to recognized industry standards and its performance is comparable to the predicate.
| Acceptance Criteria (Implied from the document) | Reported Device Performance |
|---|---|
| Compliance with ECG performance testing standards. | Non-clinical tests were conducted according to: |
| • IEC 60601-2-47:2012 (Recognition Number 3-155) | |
| • IEC 60601-2-25:2011 (Recognition Number 3-105) | |
| The testing demonstrated that CER-S is substantially equivalent to the predicate for the proposed intended use. | |
| Compliance with software development lifecycle standards. | Software development life cycle was conducted according to: |
| • IEC 62304:2015 (Recognition Number 13-79) | |
| Compliance with usability engineering process standards. | Usability engineering process was conducted according to: |
| • IEC 62366-1:2020 (Recognition Number 5-129) | |
| Compliance with risk management standards. | Potential hazards were evaluated and controlled through Risk Management activities, according to: |
| • ISO 14971:2019 (Recognition Number 5-125) | |
| Equivalence in intended use, technological characteristics, and safety/effectiveness vs. predicate. | The subject device has the same intended use as the predicate device (K213861). Any differences in technological characteristics (Enhanced software usability, Option to activate and run pacemaker analysis, Overall optimization of embedded algorithms for beat and noise detection, rhythm analysis and beat measurements, Strengthened cybersecurity measures) do not raise different questions of safety or effectiveness. The device has been shown to be substantially equivalent to the legally marketed predicate devices based on indications for use, technological characteristics, and comparison. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "No clinical tests were performed to demonstrate the substantial equivalence of CER-S." This implies that there isn't a "test set" in the traditional sense of a clinical dataset used to evaluate the device's diagnostic performance against a ground truth.
The performance evaluation relied on non-clinical tests against recognized standards rather than a clinical dataset with individual patient records. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there were no clinical tests performed with a ground truth established by experts, this information is not applicable/not available from the provided text.
4. Adjudication Method for the Test Set
Since no clinical test set was used with expert review, an adjudication method is not applicable/not available from the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
The document explicitly states, "No clinical tests were performed to demonstrate the substantial equivalence of CER-S." Therefore, no MRMC comparative effectiveness study was conducted, and information about human reader improvement with AI assistance is not available. The CER-S is a standalone software, not an AI-assisted reading tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done through non-clinical testing against recognized standards. The device itself is described as a "stand-alone software" intended to "support the clinician," not replace them, and explicitly states it "does not provide an automated interpretation and is not intended for use as the only diagnostic tool." The reported performance focused on compliance with ECG performance standards and software/risk management standards, indicating the algorithm's functionality and safety were evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance evaluation appears to be the requirements and specifications within the referenced industry standards (IEC 60601-2-47, IEC 60601-2-25 for ECG performance; IEC 62304 for software; IEC 62366-1 for usability; ISO 14971 for risk management). The device's algorithms and functions were tested to ensure they met the technical specifications and safety/performance criteria outlined by these standards, rather than a clinical ground truth like pathology or expert consensus on patient cases.
8. The Sample Size for the Training Set
The document does not provide information about the training set size for the CER-S algorithms. It mentions "Overall optimization of embedded algorithms for beat and noise detection, rhythm analysis and beat measurements," which implies an underlying development and training process, but no details are given.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).