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510(k) Data Aggregation
(24 days)
The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).
The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG. It transmits the ECG data in a specified format by Bluetooth transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.
Here's a breakdown of the acceptance criteria and study information for the COR12 ECG device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to its predicate (Vyntus ECG – K150810) by stating that they are identical in all aspects. Therefore, the "acceptance criteria" and "reported device performance" are assumed to be the same as the predicate device, as per the submission's claim of identicality.
| Feature / Acceptance Criteria | Reported Device Performance (COR12 ECG & Predicate) | Comment |
|---|---|---|
| Indications for Use | ||
| Measures Surface ECG | Yes | Identical |
| Records & Displays/Prints ECG | Yes | Identical |
| Patient Age | 4 years and older | Identical |
| Patient Weight | 20 kg or higher | Identical |
| Use Conditions | Routine ECG, resting and stress conditions | Identical |
| User | Trained healthcare professionals | Identical |
| Environment of Use | Healthcare facilities (doctor's office/hospital) | Identical |
| Technical Specifications | ||
| Records ECG only | Yes | Identical |
| Data output | Recorded and displayed on screen or printed | Identical |
| Records under | Resting and stress conditions | Identical |
| Dimensions (W x H x D) | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) | Identical |
| Weight (without battery) | 200 g (0.4 lbs) | Identical |
| 12-channel Surface ECG | Yes | Identical |
| Electrodes | Standard ECG electrodes | Identical |
| Electrode Connection | 4 mm snap, gilded | Identical |
| ECG signal Technology | Impedance measurement | Identical |
| Accuracy of ECG signal | 1.94 μV/bit resolution (at 500 Hz sampling) | Identical |
| Filter | Bandpass 0.05 Hz – 150 Hz, No line filter | Identical |
| Pacemaker detection | 4000 Hz | Identical |
| Operating Temperature | 10 – 37 °C | Identical |
| Ambient Pressure | 700 to 1060 hPa | Identical |
| Humidity | 5 – 95% RH (not condensing) | Identical |
| Power Supply | 1x AA Alkaline or rechargeable NiMH battery | Identical |
| Runtime (with AA battery) | > 5h | Identical |
| Runtime (with NiMH battery) | > 8h (2850 mAh) | Identical |
| Current Consumption | 230 mA (Operation) / 185 mA (Idle) | Identical |
| Protection Classification | Device with internal power supply, Type CF | Identical |
| Recovery Time (defibrillation) | < 8 seconds | Identical |
| EMC Emission | CISPR 11 Class B | Identical |
| EMC Immunity | IEC 61000-4 parts 2, 3, 6, 8 | Identical |
| Data Transmission | Bluetooth 2.1+EDR Protocol: SPP | Identical |
2. Sample size used for the test set and the data provenance
The submission explicitly states, "The subject and predicate devices are identical as the supplier of the predicate and thus the technical specifications are identical." This indicates that no separate test set was used for the COR12 ECG device in this submission. The device's performance is established by its claimed identicality to the predicate device. Therefore, no specific sample size or data provenance is reported for a unique test set for the COR12 ECG.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no independent test set was used for the COR12 ECG to demonstrate performance, there were no experts establishing ground truth for such a set. The claims are based on identicality to the predicate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No independent test set with adjudication was performed for the COR12 ECG in this submission.
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
Not applicable. This device is an electrocardiograph for recording and displaying ECG data and does not involve AI assistance for interpretation or comparative effectiveness studies with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware electrocardiograph for data acquisition, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the COR12 ECG, the "ground truth" for its performance is implicitly derived from the established performance and safety of its identical predicate device, the Vyntus ECG (K150810). No new ground truth was established for the COR12 ECG in this submission. The submission relies on the predicate's prior clearance which would have involved demonstrating accuracy against established standards for ECG measurement.
8. The sample size for the training set
Not applicable. This device is a measurement device (electrocardiograph) and does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
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