Search Results

ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

ScioCardio ECG transmitter is a battery powered wearable device, capable of continuously capturing a body surface ECG from the patient, storing and transmitting the data to an external device or a system wirelessly. ECG signals are captured from the conventional solid gel electrodes worn on the body using a 3 lead ECG system. Raw ECG data is stored and transmitted wirelessly to any compatible device with Bluetooth Low Energy capability. This allows visualization, analysis and interpretation which can be used for a variety of applications such as ECG monitoring, heart rate monitoring, arrhythmia detection and analysis, out-patient monitoring etc. Other than the ECG data, ScioCardio ECG transmitter also captures, stores and transmits patient's motion data from an IMU sensor providing information about the patient's activities which can also be used in above mentioned analysis and interpretations. ScioCardio ECG transmitter is an always-on device. Data acquisition, storing and transmission are all done automatically and require no patient intervention other than initializing the device. ScioCardio ECG transmitter is small in form factor and has a higher battery life, making it possible for the user to wear the device comfortably for longer durations as per specific requirements.

The ScioCardio ECG Transmitter is a physiological ECG acquisition module that records and transmits ECG data to a compatible mobile phone via Bluetooth Low Energy. The device acquires Lead III ECG signals and is intended for use on adult patients under the supervision of a physician.

Here's an analysis of the acceptance criteria and the study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format. Instead, it demonstrates substantial equivalence through comparison to predicate devices and adherence to relevant standards. The performance aspects discussed indirectly serve as acceptable performance levels.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical performance testing and states that clinical performance testing was not required to establish substantial equivalence. Therefore:

• Sample size for the test set: Not applicable for clinical data. For non-clinical tests, specific sample sizes (e.g., number of devices tested for battery life) are not provided, but the tests were "successfully conducted" or "successfully performed."
• Data provenance: Not applicable for clinical data. For non-clinical device performance, the testing was conducted by SYNERGEN Technology Labs LLC. The country of origin of the data is implicitly the USA (where the company is based), but not explicitly stated. The tests are prospective as they were performed to validate the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary. The device transmits raw data and does not perform analysis itself.

4. Adjudication Method for the Test Set

Not applicable, as clinical performance testing was not required or submitted for this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study was done. Clinical performance testing was not required. The device's function is to acquire and transmit raw ECG data; it does not include AI for interpretation or diagnosis that would typically warrant a comparative effectiveness study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The ScioCardio ECG Transmitter is a hardware device for acquiring and transmitting raw ECG signals. It explicitly states it transmits data "without making any analysis or filtering to the data acquired." Therefore, there is no embedded algorithm for diagnosis or interpretation that would require a standalone performance study.

7. The Type of Ground Truth Used

• For non-clinical performance (e.g., battery life, transmitter range, operability): The ground truth was based on engineered specifications and successful operation against those specifications (e.g., battery lasted longer than 120 hours, transmitter range was "successfully conducted").
• For standards compliance: The ground truth is the requirements outlined in the specified international and FDA recognized standards (e.g., AAMI / ANSI ES60601-1). The device was tested and found compliant with these standards, implying it met the specified performance metrics within those standards.
• For clinical data / algorithm performance: Not applicable, as clinical performance testing was not required and there's no diagnostic algorithm in the device.

8. The Sample Size for the Training Set

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as the device does not employ machine learning or AI algorithms requiring a training set.

Ask a specific question about this device