(101 days)
The ELI 200+ Audicor Option Electrocardiograph is intended to acquire, record and then store acquired cardiac data of symptomatic patients. The ELI 200+ Audicor Option can also be used to acquire both 12-lead ECG and heart sound data at the same time. The cardiac data is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with LVH, acute and age undetermined MI and detection of S3/S4 heart sounds. The S3/S4 heart sound is useful in the identification of cardiac conditions associated with Left Ventricular dysfunction.
The device is indicated for use to acquire, analyze, display and orint ECG and heart sound (COR) data.
The device is indicated for use to provide interpretation of the d sta for consideration by physicians.
The device is indicated for use in a clinical setting, by a physici: n or by trained personnel . who are acting on the orders of a licensed physician. It is not inlended as a sole means of diagnosis.
The interpretations of ECG and heart sound data (COR) offerer by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data.
The device is indicated for use on adult populations, typically sumptomatic.
The device is not intended to be used as a vital signs physiolog cal monitor. .
Evaluation of cardiac conditions such as LVH, Acute and Age Undetermined MI and detection of S3 and S4 heart sounds.
The ELI 200+ Audicor is an interpretive electrocardiograph that provides simult: neous 12-lead acquisition and is designed to be portable. It also employs Audicor Correlated Audicelectrir. Cardiography (COR) technology from Inovise Medical, Inc. that will enable acquisition of both 12-lear. ECG and heart sound data at the same time. This will be accomplished with a Mortara ELI 200+ electrocar iograph and the use of an Audicor Adaptor and Audicor Sensor. In use, the Audicor Sensor will replace tt = standard V4 electrode and connect to the Audicor Adaptor, enabling simultaneous acquisition of the ECG . gnal and an acoustical sional.
The Audicor sensor is a single-use, non-invasive, disposable medical device th: t has the ability to acquire a single-lead ECG (electrical) signal and a single-lead acoustic signal simultaneo: sly from the skin surface of a patient. It is designed to transfer these signals to an attached Audicor Adaptor, which itself connects and transfers the signals through patient leads to compatible cardiographs such as ine Mortara ELL 200+ electrocardiograph for acquisition and analysis.
The Mortara ELI 200+ Audicor device, as described in the provided 510(k) Notification K031182, does not include specific acceptance criteria or a detailed study proving the device meets said criteria in the provided document.
Instead, the document focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary requirement for 510(k) clearance. This means that instead of presenting a new performance study against defined acceptance criteria, the submission argues that the new device is as safe and effective as existing devices already on the market.
Therefore, many of the requested elements for a detailed study and acceptance criteria cannot be extracted directly from this document. However, I can provide information based on what is present regarding the device's function and the regulatory context:
1. Table of Acceptance Criteria and Reported Device Performance:
- No explicit acceptance criteria are stated in the provided document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, implying that its performance is equivalent to established standards for electrocardiographs and heart sound analysis systems.
- Reported Device Performance:
- Simultaneous 12-lead ECG acquisition and heart sound data (COR).
- Ability to acquire both 12-lead ECG and heart sound data at the same time.
- Interpretation of data for consideration by physicians.
- Evaluation of cardiac conditions such as LVH, Acute and Age Undetermined MI, and detection of S3 and S4 heart sounds.
2. Sample Size Used for the Test Set and Data Provenance:
- Not specified in the document. The 510(k) notification does not include details of a specific test set or clinical study with patient data for the ELI 200+ Audicor to prove its performance against acceptance criteria. The focus is on technological evolution and equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable/specified. Since a specific test set and ground truth establishment process are not detailed, information about experts is not provided.
4. Adjudication Method for the Test Set:
- Not applicable/specified. As no specific test set data is presented, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC comparative effectiveness study is not mentioned or described in this document. The submission is not focused on demonstrating performance improvement over human readers but rather on equivalence to existing devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a formal study. While the device provides "interpretation of the data," the indications for use explicitly state: "The interpretations of ECG and heart sound data (COR) offered by the device are only significant when used in conjunction with physician overread as well as consideration of all other relevant patient data." This indicates that standalone performance, if evaluated, is not intended for clinical use without human oversight. No standalone performance metrics are provided in this document.
7. The Type of Ground Truth Used:
- Not specified for the ELI 200+ Audicor itself in the context of a new performance study. The device's "interpretations" are stated to be "significant when used in conjunction with physician overread as well as consideration of all other relevant patient data," implying physician judgment and other clinical data form the ultimate ground truth in clinical practice.
8. The Sample Size for the Training Set:
- Not specified in the document. Information regarding a training set for the Audicor COR technology, if it involves machine learning or complex algorithms, is not included. The technology is described as "Audicor Correlated Audioelectric Cardiography (COR) technology from Inovise Medical, Inc.," which might have been developed and "trained" separately by Inovise; however, details are not in this 510(k).
9. How the Ground Truth for the Training Set was Established:
- Not specified in the document. Similar to the training set size, the method for establishing ground truth for any potential training data used in the COR technology is not provided.
Summary of Documentation's Focus:
The provided 510(k) notification for the Mortara ELI 200+ Audicor is a regulatory submission focused on demonstrating substantial equivalence to existing legally marketed predicate devices (Mortara ELI 200, Inovise's Cardiovise Interpretive Software, and HP's 1514A ECG/Phono System). This type of submission typically emphasizes technical and functional similarities, safety aspects, and intended use alignment rather than presenting new, detailed clinical performance studies against specific acceptance criteria. The document describes the device's features and its intended use for acquiring and interpreting ECG and heart sound data for certain cardiac conditions, always in conjunction with physician overread.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).