READMYHEART, MODEL RMH2.0

• K Number: K052303
• Device Name: READMYHEART, MODEL RMH2.0
• Manufacturer: DAILYCARE BIOMEDICAL INC
• Date Cleared: 2005-12-16 ( 114 days)
• Product Code: DPS
• Regulation Number: 870.2340
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: k042814

Intended Use

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.

Device Description

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.

AI/ML Overview

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):

Acceptance Criterion	Reported Device Performance	Study that Proves Device Meets Acceptance Criteria
Operating Specification, Safety & EMC Requirements	Conforms to applicable standards:

• 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.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).