(66 days)
S-Patch ExL wearable ECG patch 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. S-Patch ExL wearable ECG patch is intended for use by patients 18 years or older.
The S-Patch ExL ECG Patch System ("S-Patch ExL") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch ExL operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch ExL continuously acquires ECG signals and wirelessly transmits the data and via a smartphone application (that meets the definition of MDDS) to a compatible 3rd-party cloud-based ECG viewing platform for further analysis and interpretation by qualified medical professionals. The S-Patch ExL does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
I am sorry, but the provided text does not contain detailed information about acceptance criteria and the specific study that proves the device meets those criteria. The document is primarily a 510(k) summary for the S-Patch ExL ECG Patch System, focusing on demonstrating substantial equivalence to a predicate device (S-Patch ExL).
While it mentions performance data, it primarily refers to verification and validation activities that "established the safety and performance characteristics of the proposed subject device with respect to the predicate device." It also states that "The following performance data demonstrated conformance with special controls and substantial equivalence to predicate device's performance."
However, it does not list specific acceptance criteria in a table or describe a detailed study designed to meet those criteria. Instead, it lists the types of tests performed to demonstrate safety and performance in comparison to the predicate, such as:
- Biocompatibility Testing
- Device Reuse and Cleaning Validation
- Electrical Safety and Electromagnetic Compatibility (EMC) (compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11)
- Firmware/Software Verification and Validation Testing (states no additional testing was required as it uses the same firmware as the predicate)
- Integration and System Performance Testing (states no additional testing was required as it uses the same firmware as the predicate)
- Cybersecurity Assessment and Testing (states no additional testing was required as it uses the same firmware as the predicate)
- Human Factors Usability Validation Study (conducted according to FDA guidance)
Crucially, the document explicitly states:
- Animal Study: "Animal performance testing was not required for this device."
- Clinical Study: "Clinical study was not required for demonstrating safety, effectiveness of the subject device and significant equivalence to the predicate device."
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance, nor can I answer the questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study, as such a study was not deemed necessary for this 510(k) submission. The performance demonstration relied on showing equivalence to the predicate device through non-clinical testing and shared firmware/software.
§ 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).