(111 days)
The REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG is recorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices.
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, and which can record and store an ECG signal, and then transmit the ECG recording to a hospital or cardiology center for interpretation and review.
It is suitable for adult users, who suffer from cardio-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they move about during their daily life.
This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded ECG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.
The REKA E100 ECG Event Recorder (Cardiac Rhythm Monitor) is designed for on-demand, self-recording of a single channel ECG by patients at almost any place and any time. The recording takes 30 seconds and is transmitted to backend website for analysis and interpretation by medical professionals of the remote Monitoring Center. ECG signals are acquired by the two (2) built-in finger electrode sensors on the device. As an alternative, a better quality ECG can be recorded using the 2-leadwire cable with 2 electrodes pasted on body. The acquired signals are recorded in a build-in NAND flash memory and E100 can store up to 4000 ECG records.
The recorded EGG data can be transferred to mobile phone using micro USB cable/ 30-pin cable provided. The ECG then can be transmitted via cellular link or WiFi to an Internet depository when the patient ECG records are filed. The Internet depositories compatible with E100 can be accessed via www.reka.net and www.rekahealth.com. The compatible smart cell/mobile phones that can upload ECG records from E100 include iPhone®, Blackberry®, Symbian® and smart phones running on Android™. These mobile phones will require to install E100 Uploader (Apps) developed by REKA, the user can easily download the Apps from App World, Android Market etc. and install it.
Alternatively, the EGG signals stored in E100 can be transmitted to backend website through PC or Laptop with Internet connection by plugging E100 to computer using USB cable. For computer with Windows® & Mac®, user can easily access to the corresponding Uploader apps pre-stored in the device to run it for installation at 1ª time use. After then the Uploader runs automatically once E100 is plugged in. For computer with Linux®, user can directly upload ECG data by clicking the apps, no installation required.
Here's a breakdown of the acceptance criteria and study information for the REKA E100 ECG Event Recorder, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than specific performance metrics and their corresponding acceptance criteria that would typically be found in a detailed test report.
However, based on the document, the device voluntarily conformed to the AAMI/ANSI EC38:2007 standard, which sets performance requirements for ambulatory electrocardiographic systems. While precise numerical acceptance criteria are not explicitly stated within this summary, adherence to such a standard implies meeting its stipulated performance thresholds for aspects like accuracy, signal quality, and noise rejection for ECG recordings.
Therefore, the table below reflects what can be inferred about the acceptance criteria and performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Standards) | Reported Device Performance (Inferred) |
|---|---|---|
| Safety | Compliance with IEC 60601-1 | Met (IEC 60601-1 Safety Test) |
| EMC | Compliance with IEC 60601-1-2 | Met (IEC 60601-1-2 EMC Test) |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10 | Met (ISO 10993 Biocompatibility Test) |
| Software Quality | Compliance with IEC 60601-1-4, IEC 62304 | Met (Software V&V) |
| Functional Performance | Accuracy, compatibility (implied by functionality tests) | Met (Functionality Test, Accuracy Test, Compatibility Test) |
| Reliability | Durability, environmental resilience (implied by reliability tests) | Met (Reliability Test including drop, environment, connector, button, packaging) |
| ECG Performance | Applicable clauses of AAMI/ANSI EC38:2007 (e.g., signal bandwidth, common mode rejection, noise, heart rate accuracy, etc.) | Met (Voluntarily tested against AAMI EC38) |
| Risk Management | Compliance with ISO 14971 | Met (Risk Management according to ISO 14971) |
| Product Specifications | All defined product specifications | Met (Product Specification Verification) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., for bench tests against the predicate device or voluntary AAMI EC38 testing). It broadly mentions "extensive verification & validation testing" and "various performance tests."
The data provenance (country of origin, retrospective/prospective) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not include information about specific expert involvement in establishing ground truth for any test sets. The device's output is intended for "medical professionals of the remote Monitoring Center" or "a cardiologist or a physician" for analysis and interpretation, implying that professional medical evaluation would act as the ground truth in a clinical setting, but this is not described in the context of a specific test set within this submission.
4. Adjudication Method for the Test Set
No information about an adjudication method is provided, as specific human-interpreted test sets are not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device's primary function is as a recorder and transmitter of ECG data for subsequent interpretation by medical professionals, rather than an AI-driven interpretive tool itself.
6. Standalone Performance Study
The document describes "Bench Test against predicate device" and "Performance Test voluntarily against AAMI EC38." These would represent standalone performance studies of the device's ability to acquire and record ECG signals according to established standards and in comparison to existing devices. However, explicit metrics beyond "met" or "demonstrate that the REKA E100 is as safe and effective" are not provided.
7. Type of Ground Truth Used
For the instrument's performance, the ground truth would be the established technical specifications and standards (e.g., AAMI EC38 for ECG performance, and the predicate device's performance for comparison). The document does not describe the use of expert consensus, pathology, or outcomes data as ground truth for validating the device's recording capabilities within this section. Clinical interpretation by medical professionals is the intended use for the recorded ECG data, but not explicitly the ground truth for device validation.
8. Sample Size for the Training Set
This device is an ECG recorder and transmitter, not an algorithm that performs automated interpretations requiring a training set. Therefore, there is no mention of a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm mentioned for this device, this question is not applicable.
§ 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).