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The Palm ECG Recorder™ Model EP-201C/202C is intended for self-testing and home health care use. The Palm ECG Recorder™ Model EP-201C/202C records, stores and transfier ECG waveforms, R-R graph and average heart rate data and presents these cardiological events in a synchronized time scale for interpretation by a physician trained in such an analysis. This is a prescription device for use only under the direction of a physician. A software user infare allows viewing. This screening tool is not intended for use as a diagnostic tool ar as a subtitute for a hospital diagnostic ECG device. This device is not intended for simulaneously recording and transmission of a user's ECG signal. This device is not recommended for use with in planted pacemakers.

The Palm ECG Recorder™, Model EP-201C/202C, is made by Parama-Tech Co., Ltd. This wireless ECG Monitor is portable, non-invasive and handheld. This is a Class II device that measures and displays EGC waveforms, R-R graph, an average heart rate along with comments. Once this device is prescribed by a physician, the Palm ECG Recorder "", can be used anytime, anywhere by anyone. This devices allows acquisition and transmission of ECG data from the user to a personal computer.

This device is suitable to detect transient symptoms that may suggest abnormal cardiac conditions to monitor cardiac conditions on a daily basis. This device is ideally suited for health care.

The provided text describes the Parama-Tech Co., Ltd. Palm ECG Recorder™, Model EP-201C/202C, and its clearance for marketing. However, the document does not contain specific acceptance criteria for performance or detailed information about a study proving the device meets such criteria in terms of clinical accuracy or effectiveness. The performance testing mentioned is limited to electrical safety, EMI/EMC, and temperature measurement accuracy, with a vague reference to "results of clinical testing" without elaboration.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the available information:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Test set sample size: Not specified.
• Data provenance: Not specified, other than "clinical testing" was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The device's intended use states that "further interpretation of ECG data recorded by Palm ECG Recorder can be sent to the prescribing physician," implying human interpretation, but this is not about ground truth establishment for a test set.

4. Adjudication method for the test set

• Not specified.

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 specified. The device is a "screening device" that records and stores ECGs for physician interpretation; it does not appear to involve AI assistance for interpretation within the context of this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not specified. The device itself is for "self-testing and home health care use" and "records, stores and transfers ECG waveforms...for interpretation by a physician." This inherently involves a human-in-the-loop for interpretation.

7. The type of ground truth used

• Not specified.

8. The sample size for the training set

• Not applicable/Not specified. This document does not describe an AI/algorithm that would require a training set in the conventional sense for clinical performance. The "calibration" is factory-established.

9. How the ground truth for the training set was established

• Not applicable/Not specified.

Summary of what the document does state regarding "performance testing":

The premarket notification for the Palm ECG Recorder™, Model EP-201C/202C, included results of testing for:

• Electrical safety
• EMI/EMC
• Temperature measurement accuracy
• "Clinical testing" (without further detail on methodology, results, or objectives)

The device is cleared as substantially equivalent to two predicate devices (Read My Heart K042814 and OMRON HCG-801 K060766), suggesting that its performance, in general, is considered comparable to these legally marketed devices based on the submitted information. However, the specific details of clinical performance acceptance criteria and proof of meeting them are not elaborated in this 510(k) summary. The emphasis appears to be on safety, technical function, and equivalence rather than a detailed clinical performance study with defined diagnostic metrics.

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