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Dimetek Micro Ambulatory ECG Recorder is intended for ECG detecting, recording and playback by adult patients who are concerned about their heart rhythm. It is used both in the clinics and home care environment.

User can choose the monitor mode and event mode to record the ECG data when feeling any heart condition occur. The device allows user to record their ECG data in TF card and playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia.

The ECG data in TF card can be downloaded to PC, and be read by ECG viewer software.

The device is NOT designed or intended for medical diagnosis.

The recorder is a handhold, light weight, battery-operated physiological device designed for recording ECG data. For its small size, it may be used in a clinical or non-clinical setting to record physiological signal waveforms while the patient is unattended; the device provides Real-time display function.

The device has a resolution of 24-bits with a fundamental sampling frequency of 100, 200, or 400 SPS and is stored un-compressed on a removable TF card. The sampling rate, display rate, display amplitude could be defined through control interface; meanwhile, heart rate would also be measured.

The Micro Ambulatory ECG Recorder is used for self-testing before diagnosis and is not recommended for users with implanted pacemakers or defibrillators. It works with a single lead, and has 4 testing modes:

• a) Hand contact mode, place your left and right index fingers are touching the touc pads integrated on the device.
• b) Leg contact mode, place your index finger on one electrode of the device and place your leg on the other electrode.
• c) Chest contact mode, place your right index finger on the right touch pad of and place left touch pad on your chest.
• d) Leadwire mode, using leadwires and two disposable electrodes. Paste the disposable electrodes on your body and connect them to the device through the lead wire cable.

The measurement data can be stored in the TF card, and then you can download to PC, and read the ECG by ECG Viewer software.

The device is NOT designed or intended for medical diagnosis.

The provided text, K131572, describes a 510(k) submission for the Dimetek Micro Ambulatory ECG Recorder (DiCare m1CP). However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or detailed performance data beyond a general statement of "Performance - same" when compared to predicate devices.

The document focuses on establishing substantial equivalence to predicate devices (Omron HCG-801 Portable ECG Monitor and TaiDoc V-TRUST TD-2202 Portable ECG Recorder) based on similar intended use, operational principles, patient population, technical parameters, and safety characteristics.

Therefore, many of the requested details for a study proving acceptance criteria cannot be extracted from this specific 510(k) summary.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

Note: The acceptance criteria are largely implied by the declaration of "substantial equivalence" to predicate devices across various characteristics. The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity, specificity, or error rates) for clinical performance. The "reported device performance" is primarily a statement of similarity or sameness to predicate devices rather than independent quantitative results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance (Country of Origin): Not specified.
• Retrospective or Prospective: Not specified.

The submission generally references compliance with various standards (e.g., IEC, ANSI/AAMI, ISO) but does not describe a performance study with a specific test set, patient data, or clinical evaluation. The statement "The following practices were followed and monitored for development of the DiCare m1CP ECG Recorder" refers to adherence to regulatory standards for design and safety, not a clinical performance study as typically understood for an AI device.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

The device is not intended for medical diagnosis, but for "playback the data for analysis by a physician or those knowledgeable about ECG morphology, rhythm, and arrhythmia." This implies that human review is part of the intended use, but there's no mention of expert ground truth establishment for a test set within this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified, as no specific test set or clinical performance study is described.

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

• MRMC Study: No. This device is a basic ECG recorder and not described as having AI assistance for interpretation.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable in the context of an algorithm's diagnostic performance. The device records ECG data for human analysis rather than providing automated diagnosis. Its standalone performance relates to its ability to accurately acquire and store ECG signals, which is generally covered by compliance with standards like ANSI/AAMI EC38 for ambulatory electrocardiographic systems. No specific data on this "standalone" signal acquisition performance is detailed beyond meeting standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not specified, as no specific performance study requiring ground truth is detailed. The device records raw ECG data for a physician to interpret.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is an ECG recorder, not an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable. This device is an ECG recorder, not an AI/ML algorithm that requires a training set.

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