(234 days)
The ePatch® is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety.
The ePatch® is intended for use by adolescents 18-21 and adults.
The ePatch® ECG Recorder is intended for continuous recording of heart action potentials (ECG). While in use, the sensor is connected to a compatible ECG electrode and placed on the patient.
The ePatch® ECG Recorder is a small digital Holter recorder intended for use by professionals to acquire continuous ambulatory recording of heart action potentials (ECG) from a patient through a compatible ECG patch electrode. The ePatch® is intended for use in a clinical, point of care or at a patient setting. The recording time of the ECG recorder is dependent on the set configuration of the recorder (sample rate and channel selection). The patient's ECG is recorded to the ePatch® ECG Recorder and then transferred via the ePatch® USB cable to a Holter analysis system for review by physician or other qualified personnel.
The ePatch® ambulatory electrocardiograph (ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 1, 2 or 3 channels of ECG up to 9 days. The device is composed of a large ECG electrode and an ECG recorder. The ECG recorder snaps onto the electrode and records until the recorder is removed from the electrode. At the end of the recording, the recorder can be plugged into a PC via a USB cable. The ECG recording can be transferred in an available file format at can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers. The ePatch® can be worn continuously up to 5 days in homes, healthcare facilities, hospitals, and wherever the patient may go. The components that are part of the ePatch® recorder are a lead wire, USB cable and the ePatch® electrode.
During the recording the patient wears the ePatch® connected to an electrode on the upper sternum or an alternative placement on the upper torso. The ePatch® consists of a microprocessor, measuring circuit, memory, data storage, lightemitting diode (trans-illuminates the plastic casing), and contract to the electrode. In addition to that, ePatch® contains firmware to control the collection of the ECG data and software to transfer to the processing software.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics for the ePatch® device. The document is a 510(k) premarket notification letter and summary, which focuses on establishing substantial equivalence to predicate devices rather than providing a standalone performance study.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document lists performance standards and categories of testing but does not provide quantitative acceptance criteria or corresponding reported performance values for the ePatch® device itself. Instead, it states that "The technological characteristics of the proposed ePatch® are very similar to the predicate devices." and broadly mentions "Design Verification" as a performance standard.
A table format would look like this, but the "Acceptance Criteria" and "Reported Performance" columns cannot be filled with specific numbers from this document:
| Characteristic/Test Category | Acceptance Criteria (from recognized standards) | Reported Device Performance (ePatch®) |
|---|---|---|
| Frequency Response | (Refer to IEC 60601-2-47 for detailed requirements) | 0.05-215 Hz |
| Input Impedance | (Refer to IEC 60601-2-47 for detailed requirements) | >10MOhms |
| Resolution | (Refer to IEC 60601-2-47 for detailed requirements) | 12 bit or 16 bit, depending on customer preference |
| Biological Compatibility | Conformance to ISO 10993-1 | Conforms to ISO 10993-1 |
| Electrical Safety & Essential Performance | Conformance to IEC 60601-1, IEC 60601-2-47, IEC 60601-1-11 | Conforms to IEC 60601-1, IEC 60601-2-47, IEC 60601-1-11 |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 |
| Software Verification & Validation | Conformance to IEC 62304 | Performed (stated) |
| Usability | Conformance to IEC 62366 | Performed (stated) |
| Patch Adhesion & Signal Quality | (Implied to be comparable to predicate devices and acceptable for intended use) | Validation conducted to support substantial equivalence (stated) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document mentions "Validation of patch adhesion and signal quality data were conducted to support substantial equivalence" and "Non-clinical testing summary," which includes biocompatibility, electrical safety, EMC, software, and usability testing. However, it does not provide any specific sample sizes for these tests, nor does it detail the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The document describes a medical device for ECG recording, not an AI or diagnostic interpretation system that would typically require expert-established ground truth in the way a diagnostic algorithm would. The "ground truth" for an ECG recorder would be the accurate capture of electrical heart signals, which is validated through technical performance standards rather than expert consensus on diagnostic images or reports.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided and is generally not applicable to the technical validation of an ECG recording device. Adjudication methods are typically employed in studies involving human interpretation or subjective assessments, which are not the primary focus of validating an ECG recorder's hardware and software functionality.
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:
This information is not provided and is not relevant to the ePatch® device as described. The ePatch® is an ECG recorder, not an AI-powered diagnostic interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be performed for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided and not directly applicable. The ePatch® is a physical device that records ECG data, which is then transferred to a Holter analysis system for review by qualified personnel. While it has firmware and software, it's not described as an "algorithm only" device in the context of standalone diagnostic performance. Its performance is tied to its ability to accurately record physiological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical performance of the ECG recorder, the "ground truth" is established by conformance to recognized standards (e.g., IEC 60601-2-47 for ambulatory electrocardiographic systems) and the accurate capture of electrical heart activity. This is not typically based on expert consensus, pathology, or outcomes data in the same way a diagnostic algorithm's output would be. The "ground truth" for signal quality means the device faithfully reproduces the biological signal within specified technical tolerances.
8. The sample size for the training set:
This information is not provided. As the ePatch® is an ECG recorder focused on hardware and embedded software for data acquisition and storage, it typically does not involve a "training set" in the machine learning sense. The firmware and software are likely developed and validated through traditional software engineering and testing processes against specifications derived from regulatory standards, rather than being "trained" on a dataset.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable for the reasons stated in point 8.
§ 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).