(118 days)
S-Patch Ex 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, pre-syncope, syncope, fatigue, chest pain and/or anxiety. S-Patch Ex wearable ECG patch is intended for use by patients 18 years or older.
The S-Patch Ex ECG Patch System ("S-Patch Ex") is a light-weight electrocardiogram ("ECG") data collection device. The S-Patch Ex operates wirelessly, and due to its compact size, it is unobtrusive during daily activity. The S-Patch Ex 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 Ex does not include but works with 3rd-party lithium coin batteries and 3rd-party ECG electrodes.
The provided text is a 510(k) summary for the S-Patch Ex Wearable ECG Patch. It describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device. However, the document does not contain details about specific acceptance criteria for a performance study or the results of such a study in terms of quantifiable metrics like accuracy, sensitivity, or specificity against established ground truth.
The document states that "Multiple system performance testing was successfully performed, demonstrating comparative performance against traditional multi-leads ECG monitors and acceptable electrode placement performance. An integration testing was also conducted, demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms." but it does not provide the actual data or specific acceptance criteria for these tests.
Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. The document focuses on demonstrating substantial equivalence through similar indications for use, technological characteristics, and conformance to general device standards (biocompatibility, electrical safety, software V&V, cybersecurity, human factors). It explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." This means a formal comparative effectiveness study against human readers or a standalone algorithm performance study with a defined ground truth and statistical metrics was not performed for this 510(k) submission.
Here's what can be inferred or stated as not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Signal Quality (comparative to traditional multi-leads ECG monitors) | Not specified (implied to be "acceptable") | "demonstrating comparative performance against traditional multi-leads ECG monitors" |
| Electrode Placement Performance | Not specified (implied to be "acceptable") | "acceptable electrode placement performance" |
| Integration with 3rd-party ECG viewing platforms | Not specified (implied to be "good compatibility") | "demonstrating good ECG signal quality and compatibility with 3rd-party ECG viewing platforms" |
| Biocompatibility | Conformance to ISO 10993-1:2009 | Testing conducted and complied satisfactorily. |
| Device Reuse and Cleaning Validation | Disinfection method satisfactorily evaluated, no new questions of safety/effectiveness raised. | "low-level disinfection method was satisfactorily evaluated and did not raise any new or different questions of safety or effectiveness." |
| Electrical Safety & EMC | Compliance with specified standards (ES60601-1:2005(R)2012, IEC 60601-1-2 Ed 4.0, IEC 60601-1-11 Ed 2.0) | "The subject device complies with the electrical safety and electromagnetic compatibility requirements." |
| Firmware/Software V&V | Conformance to FDA Guidance (May 11, 2005) for "moderate" level of concern software. | "Software verification and validation testing was conducted, and documentation is provided as recommended." |
| Cybersecurity | Conformance to FDA Guidance (October 2, 2014) | "Cybersecurity assessment and testing were conducted, according to FDA's Guidance." |
| Human Factors/Usability | Conformance to FDA Guidance (February 3, 2016) | "A human factors summative usability validation study was conducted, according to FDA's Guidance." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any performance testing.
- Data Provenance: Not specified. (The document mentions the manufacturer is in the Republic of Korea, but no information on data origin is provided).
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available as the document does not describe a clinical study with ground truth established by experts for performance evaluation. The device does not include automated ECG analysis and relies on "further analysis and interpretation by qualified medical professionals" using 3rd-party platforms.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not available. No clinical study with expert adjudication is described for performance evaluation.
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:
No. The document explicitly states: "Clinical study was not required for demonstrating substantial equivalence to the predicate device." Furthermore, the S-Patch Ex "does not include automated ECG analysis and is not intended to be used with 3rd party automated ECG analysis software." Therefore, no MRMC study involving AI assistance would have been conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. The device itself does not perform automated ECG analysis. Its function is to collect and transmit ECG data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not available. As no clinical performance study requiring ground truth was presented, this information is not provided. The performance testing appears to be primarily technical (signal quality, electrical safety, software functionality), not diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set:
Not applicable/Not available. This device is a data collection device and does not inherently involve an AI algorithm that would require a "training set" for diagnostic performance.
9. How the ground truth for the training set was established:
Not applicable/Not available. (See 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).