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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.

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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:

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).

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