(282 days)
CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings.
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.
The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients.
Note: 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, but not limited to, 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), for the submission of continuous ECG recording to the FDA ECG Warehouse.
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.
The provided text does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for the CER-S device, which outlines its purpose, regulatory information, and a high-level overview of some testing. However, it explicitly states: "No clinical tests were performed to demonstrate safety and effectiveness of CER-S". This means there was no clinical study with human participants to measure the device's performance against specific acceptance criteria in a real-world setting.
Instead, the submission relies on non-clinical tests (performance testing against existing standards and software development life cycle adherence) and substantial equivalence to a predicate device.
Therefore, I can only provide information based on what is available in the text. Many of your requested points will be answered with "Not applicable" or "Information not provided in the document."
Here is the breakdown based on the provided text:
Acceptance Criteria and Device Performance Study (CER-S)
As stated in the 510(k) Summary, no clinical tests were performed to demonstrate the safety and effectiveness of CER-S. The submission relies on non-clinical performance testing and software development life cycle adherence to established standards, as well as arguments for substantial equivalence to a predicate device. Therefore, a study demonstrating the device meets performance acceptance criteria via a clinical trial with human-in-the-loop or standalone AI performance metrics is not detailed in this document.
The document mentions compliance with several non-clinical standards for ECG performance and software development. These standards inherently have their own acceptance criteria, but the specific performance results against these criteria are not numerical values reported in a table within this summary.
1. Table of Acceptance Criteria and Reported Device Performance
Given that no clinical study measuring specific performance metrics against clinical acceptance criteria was conducted and detailed in this summary, a table of this nature cannot be generated from the provided text. The document states:
- "The following non-clinical tests have been conducted on the Subject Device:
- ECG performance testing, according to: ANSI/AAMI EC57:1998/(R)2003 and IEC 60601-2-47:2012 (Recognition Number 3-155) IEC 60601-2-25:2011 (Recognition Number 3-105)
- Software development life cycle, according to: ANSI AAMI IEC 62304:2006 (Recognition Number 13-32)
- Usability engineering process, according to: IEC 62366:2007"
- "The testing demonstrated that CER-S is safe and effectiveness for the propose intended use."
While these standards contain acceptance criteria for the device's functions (e.g., ECG signal processing accuracy, software robustness), the specific quantitative results are not reported in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable, as no clinical test set/study is detailed. The non-clinical tests would have used synthetic or recorded ECG data, but the "sample size" of such data is not specified.
- Data Provenance: Not applicable for a clinical test set. The document refers to "data acquired from electrodes with conductive paste/gel... from any device used for the arrhythmia diagnostics." The origin (country, retrospective/prospective) of this data, if used for internal validation, is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as no clinical test set/study requiring expert ground truth is detailed.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no clinical test set/study is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or detailed for AI assistance versus human-alone performance. The device is described as an "additional tool to aid in the interpretation of ECG data" and explicitly states it "does not provide an automated interpretation and is not intended for use as the only diagnostic tool." This suggests it's an analysis and review tool, not a standalone AI diagnostic.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
- Standalone Performance Study: No, a standalone (algorithm only) performance study in the sense of an AI diagnostic evaluating cases without human intervention is not described. The device is a software suite for analyzing, editing, reviewing, and reporting, implying human interaction. It also explicitly states it "does not provide an automated interpretation."
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable for a clinical study. For the non-clinical ECG performance testing, the ground truth would be defined by the known characteristics of the ECG signals and simulated arrhythmias as per the testing standards (e.g., ANSI/AAMI EC57).
8. Sample Size for the Training Set
- Sample Size (Training Set): Not provided. The document describes the device as a "tool, designed to offer a framework for the interaction of different software-modules," some of which perform "ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection." While these functions imply some form of algorithm or model development, the document does not specify if or how an explicit "training set" (in the machine learning sense) was used, nor its size.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment (Training Set): Not provided. If algorithms within the software were developed using training data, the method for establishing ground truth for such data is not described in this summary.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).