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ReadMyHeart OTC version is intended to record, store and transfer Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device. The ReadMyHeart OTC version has simple software user interface without ECG trace viewing function.

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes signals of users with the device and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate, ST segment and RRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode which will be provided separately. ReadMyHeart is powered by battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

Unfortunately, the provided text does not contain the detailed study information required to populate the requested table and answer all the questions. The document is a 510(k) summary for a modification to an existing device, ReadMyHeart, and focuses primarily on demonstrating substantial equivalence to the predicate device.

Here's what can be extracted and what is missing:

Missing Information:

• Acceptance Criteria: While the document mentions conformity to various IEC standards and performance tests against the "MIT-IBH database and simulators," it does not explicitly state specific quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, or specific thresholds for heart rate detection accuracy).
• Reported Device Performance: No specific performance metrics (like percentage accuracy for heart rate, R-R interval, etc.) are reported from any tests, clinical or otherwise, for the modified device. It only states that the performance "meets the requirements" of the MIT-IBH database.
• Sample Size for Test Set: Not mentioned.
• Data Provenance for Test Set: Not mentioned (e.g., country of origin, retrospective/prospective). The MIT-IBH database is a known public dataset, but details of how it was used for this specific device's test are absent.
• Number of Experts for Ground Truth: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned. The document explicitly states "no clinical validation for ECG parameters is required" due to the algorithm and hardware being the same as the original cleared device. This strongly suggests no human-in-the-loop study with AI assistance.
• Standalone Performance: While it mentions testing against the MIT-IBH database, no specific standalone performance metrics are reported.
• Type of Ground Truth Used: For the MIT-IBH database, the ground truth would typically be expert annotations on ECGs. However, this isn't stated for this specific submission.
• Sample Size for Training Set: Not mentioned.
• How Ground Truth for Training Set was Established: Not mentioned.

What can be inferred from the document:

• Device Name: ReadMyHeart OTC version
• Predicate Device: ReadMyHeart (K042814)

Table of Acceptance Criteria and Reported Device Performance (Based on available info):

• IEC 60601-2-25
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-2-47
• IEC 60601-2-51 | Internal Testing & Documentation of Conformity:
• All Safety test according to IEC 60601-2-25 & IEC 60601-1
• EMC tests according to IEC 60601-1-2
• Performance tests according to IEC 60601-2-47 and IEC 60601-2-51 voluntarily
• Environment tests are tested to comply with the safety requirements |
  | ECG Parameter Performance (Heart Rate, R-R interval) | Meets the requirements (implicit equivalence to predicate) | Testing with MIT-IBH database and simulators:
• "The performance is also tested with MIT-IBH database and simulators and meets the requirements."
  Previous Clearance of Predicate Device:
• "Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the original cleared device, ReadMyHeart, no clinical validation for ECG parameters is required." |

Detailed Answers to Questions (based on the provided text):

1. A table of acceptance criteria and the reported device performance: See table above. Critically, specific numerical acceptance criteria and performance metrics are not provided in this document. The stated "acceptance" is primarily conformity to standards and "meeting requirements" of the MIT-IBH database, implying sufficient accuracy without quantifying it in this summary.

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

   • Sample Size: Not specified.
   • Data Provenance: The MIT-IBH database is mentioned. This is a public database of ECG recordings, typically with expert annotations. The document does not specify which recordings from the database were used or if any additional specific patient data was included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in this document. For the MIT-IBH database, the ground truth would have been established by experts (likely cardiologists or electrophysiologists), but this information is not provided within this specific submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned. Given the use of a public database, the ground truth would have been pre-established.

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, "Since the ECG parameters algorithm and hardware design in this device is exactly the same as in the original cleared device, ReadMyHeart, no clinical validation for ECG parameters is required." This indicates no new clinical study, especially one involving human readers with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, in part. The document states, "The performance is also tested with MIT-IBH database and simulators and meets the requirements." This indicates a standalone (algorithm only) performance assessment, but specific results are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the MIT-IBH database, the ground truth would typically be expert annotations on the ECG signals.

8. The sample size for the training set: Not mentioned. It's possible the original ReadMyHeart was trained on data, but this document is a modification filing and doesn't detail the training for the unchanged algorithm.

9. How the ground truth for the training set was established: Not mentioned.

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The device is intended for home use by users who might have transient symptoms that may suggest cardiac conduction abnormity or by users who want to monitor the cardiac function for HOME HEALTH CARE from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user. The intended users are adults above 20 years old. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The device detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. Users with implanted pacemaker are not recommended to use this device.

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes ECG signals of users with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. The device also detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis when recording the signal for 180 seconds. The HRV is not intended to produce any interpretation of those measurements or any kind of diagnosis. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually. Furthermore, ReadMyHeart (Model RMH3.0) is modified and has generally the same design from DailyCare BioMedical Inc.'s prior device – ReadMyHeart (RMH2.0, K042814).

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the ECG parameters algorithm and hardware design in this device (ReadMyHeart RMH 3.0) are exactly the same as in the predicate device (ReadMyHeart RMH2.0, K042814), thus no clinical validation for ECG parameters was required for the RMH 3.0.

Therefore, the acceptance criteria and performance reported mainly pertain to the irregular heartbeat (IHB) detection function.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated, but the "MIT-IBH database" was used. The exact number of recordings or patients from this database used for testing is not specified.
• Data Provenance: The "MIT-IBH database" (likely referring to the MIT-BIH Arrhythmia Database) is a publicly available database of physiological recordings. It contains recordings from various medical centers in Boston and other locations. It is a retrospective dataset.

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

• Not explicitly stated for the irregular heartbeat detection study. However, the MIT-BIH Arrhythmia Database is well-annotated by experts in cardiology, often physicians and technicians specialized in ECG interpretation.

4. Adjudication method for the test set:

• Not explicitly stated, but for the MIT-BIH Arrhythmia Database, the ground truth annotations were established through an expert review process, typically involving multiple cardiologists or highly trained technicians converging on a consensus.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• The study described is a comparison of the device's IHB detection function against a database and simulators, not a study involving human readers with and without AI assistance.

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

• Yes, a standalone performance evaluation was done for the irregular heartbeat detection function. The device's algorithm was tested against the MIT-IBH database and simulators.

7. The type of ground truth used:

• For the irregular heartbeat detection, the ground truth was derived from the expert annotations/consensus within the "MIT-IBH database" (likely the MIT-BIH Arrhythmia Database), which is based on expert cardiological interpretation of ECGs.

8. The sample size for the training set:

• Not explicitly stated. Given that the ECG parameters algorithm is "exactly the same" as the predicate device (RMH2.0), the training would have occurred for that prior version. For the IHB detection, if the algorithm was trained on the MIT-IBH database, the training split size separate from the test set is not specified.

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

• Not explicitly stated. Assuming the IHB algorithm was developed or refined using data from the MIT-BIH Arrhythmia Database, the ground truth for the training set would also have been established through expert annotations/consensus on ECG waveforms within that database.

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The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of Electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The intended user are Users who are above 20 years old.

The user is normally not required to apply electrode on the body. Two electrodes integrated within the device are provided. The user has to press his thumbs on the two electrodes in order record the ECG signal.

The User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason.

The recorded data can be downloaded to Personal Computer via USB interface port. This device is not intended for use as precisely diagnostic tool. This device is also not intended for recording and transmission of user's ECG signal simultaneously. Users with implanted pacemaker are not recommended to use this device.

ReadMyHeart is a handheld, personalized use, dry electrode and affordable ECG recording device that records user's cardiac functions for daily health check. It takes ECG signals of user/patient with thumbs press on electrode at ReadMyHeart gently. The device will record user's ECG signal for 30 seconds, and automatically stores the last 15 seconds signals into the build-in memory, while three parameters measured, mainly, Heart Rate (HR), ST segment and QRS interval of cardiac ECG signal, displays on LCD of the device. User may also record ECG signals optionally through auxiliary external electrode provided separately, if thumb pressings are inconvenient for any reason. The data stored in the memory can be transferred to Personal Computer via USB. With friendly GUI software provided separately, data stored in ReadMyHeart can be printed for analysis, and for long-term tracking. ReadMyHeart is powered by internal battery source. Users may activate the device to acquire ECG Lead I information voluntarily and mutually.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study for ReadMyHeart

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device conforms to applicable PREDICATE device standards and a comparison study was performed. It does not explicitly state quantitative acceptance criteria for the ReadMyHeart device itself, nor does it provide specific numerical performance metrics. Instead, it relies on demonstrating comparability to a predicate device and adherence to general safety and performance standards.

2. Sample Size for the Test Set and Data Provenance:

The document mentions "a comparison study with a hospital use common electrocardiograph recorder was performed," and "recordings performed on the subjects." However, it does not specify the sample size (number of subjects/cases) used for this comparison study.

The data provenance is implied to be clinical, as it states "recordings performed on the subjects" and compares against "a hospital use common electrocardiograph recorder." However, it does not explicitly state the country of origin nor whether it was retrospective or prospective. Given the nature of a comparison study for a new device, it would most likely be prospective data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the comparison study. It only mentions that the recordings should be "analyzed by a trained physician" as part of the intended use, but this is not tied to the specifics of the validation study.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the comparison study's test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The comparison described is for the device's output (ECG recordings) against a standard hospital recorder, not for human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI is mentioned.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was implicitly done. The "comparison study with a hospital use common electrocardiograph recorder" assesses the performance of the ReadMyHeart device (algorithm + hardware) directly against a benchmark, independent of human interpretation as the primary outcome. The report claims "highly comparable" recordings.

7. Type of Ground Truth Used:

The ground truth used for the comparison study appears to be data obtained from a "hospital use common electrocardiograph recorder." This suggests that the standard hospital ECG served as the reference standard against which the ReadMyHeart's ECG recordings were compared. This could be considered a form of "reference device" or "clinical standard" ground truth.

8. Sample Size for the Training Set:

The document does not mention a training set, nor its sample size. The device is presented as a recording device, not one employing machine learning that typically requires a separate training phase. Its performance is validated through comparison to a standard, rather than through a machine learning model's training and testing regimen.

9. How the Ground Truth for the Training Set Was Established:

Since no training set is mentioned (as the device is not described as a machine learning system), the document does not describe how ground truth for a training set was established.

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