(266 days)
The Audicor® System, when used with AUDICOR Sensors on the chest wall, is intended for use in acquiring, analyzing and reporting ECG and heart sound data and to provide interpretation of the data in an integrated ACG (acoustic cardiograph) report for consideration by physicians. Audicor systems allow detection, reporting and interpretation of standard ECG data as well as advanced parameters such as EMAT, LVST, S3 strength, S4 strength, and SDI.
Data may be reported in a single snapshot report and in a trended report format where multiple data points are trended over time. The Audicor system also accepts and analyzes downloads of up to 48 hours of patient data from an optional ambulatory ECG/heart sounds collection device.
ECG and heart sound data offered by the device are only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device is intended for use only under the direct supervision of a physician and is for use on adults (≥ 18 years).
The Audicor 200 is a stand-alone device that can be used to capture 10-second snapshots of ECG and heart sounds in patients suspected of heart failure or acute coronary syndrome.
The Audicor TS system, a combination of the Audicor 200 with an Audicor-enabled laptop computer, is used to display and analyze patient data over time in a trended format. The trending system can be used in monitoring patient changes during therapeutic treatment or during CRT studies.
The Audicor system, when used with either a 10 wire or 4 wire patient cable analyzes and reports the following advanced parameters and a systolic dysfunction index (SDI) calculated from advanced parameters:
LVST ( Left Ventricular Systolic Time )
LVDT (Left Ventricular Diastolic Time)
PADT (Pre-atrial Diastolic Filling Time)
AAFT (Accelerated Atrial Filling Time )
EMAT (QS1, Electromechanical Activation Time)
QS2
R-R Interval
S3 Strength
S4 Strenth
SDI (Systolic Dysfunction Index)
The Audicor-enabled laptop computer also accepts, analyzes and displays trended data from an optional ambulatory data collection harness for trend and event analysis.
The provided text describes modifications to the AUDICOR 200 system and the addition of an AUDICOR Hemo Ambulatory Monitor. However, it does not explicitly detail acceptance criteria or a study designed to prove the device meets specific performance criteria through statistical metrics (like sensitivity, specificity, or AUC) against a defined ground truth.
Instead, the document focuses on regulatory compliance and substantial equivalence to predicate devices, particularly regarding safety standards and technological characteristics.
Here’s a breakdown of what can be extracted based on the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The document lists compliance with various safety and electrical standards (e.g., ANSI/AAMI EC-11, EN 60601-1, IEC 60601-2-25, IEC 60601-2-51, ANSI/AAMI EC38:1998 for the ambulatory component). While these are "performance standards" in the context of device safety and functionality, they are not framed as specific clinical acceptance criteria for diagnostic performance (e.g., a device must achieve X sensitivity for detecting Y condition).
2. Sample size used for the test set and the data provenance
This information is not provided. The document describes the device and its intended use but does not detail any specific clinical performance study with a test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided.
4. Adjudication method for the test set
This information is 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
A MRMC comparative effectiveness study is not mentioned. The document describes the device's role in acquiring, analyzing, and reporting data for physicians' consideration, but it does not evaluate how the device "assists" human readers or the effect size of such assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on algorithm-only performance with clinical metrics is not described. The device is intended "only when used in conjunction with physician over read as well as consideration of other relevant patient data." This strongly implies it is not a standalone diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided as no specific clinical performance study for diagnostic accuracy is detailed.
8. The sample size for the training set
This information is not provided as no machine learning algorithm training is explicitly described with specific data sets. The device "analyzes and reports" data, but the method of analysis for parameters like SDI is not detailed as a trained algorithm.
9. How the ground truth for the training set was established
This information is not provided.
Summary of Device and Regulatory Context (based on provided text):
The document is a "Summary of Safety and Effectiveness" for an update to the Inovise Medical AUDICOR 200 and the addition of the AUDICOR Hemo Ambulatory Monitor. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily the GE Medical Systems SEER Light Holter Recorder.
The substantial equivalence argument for the ambulatory component centers on:
- Technological characteristics: Both are small, wearable, battery-powered devices that acquire ECG data using limited leads and store data in non-volatile memory for download.
- Differences: The Audicor system requires proprietary sensors and performs analysis on recorded data, whereas the GE SEER Light does not.
The "study" referenced in the document is the set of tests performed to ensure compliance with recognized electrical and safety standards (e.g., AAMI, EN, IEC standards for electrocardiographs and ambulatory ECG devices). This means the device was demonstrated to operate safely and within electrical specifications, but not necessarily to achieve specific clinical diagnostic accuracy metrics in a patient population.
The device's intended use explicitly states that the ECG and heart sound data are "only significant when used in conjunction with physician over read as well as consideration of other relevant patient data," and it is for use "only under the direct supervision of a physician." This positions the system as a data acquisition and reporting tool that aids physicians, rather than a standalone diagnostic or interpretative device with its own diagnostic accuracy claims against a ground truth.
§ 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).