KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER

• K Number: K111745
• Device Name: KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
• Manufacturer: CARD GUARD SCIENTIFIC SURVIVAL, LTD.
• Date Cleared: 2011-08-01 ( 41 days)
• Product Code: DSH
• Regulation Number: 870.2800
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K020825 , K101639

Intended Use

This device is indicated for diagnostic evaluation of patients who experience transient symptoms such as:

• . Dizziness
• Palpitations .
• . Syncope
• Chest pain .

Device Description

The KOH Express AF cardiac event recorder ("KOH" or "KOH Express AF" in short) is designed for the diagnostic evaluation of transient cardiac symptoms. The KOH is capable of storing up to 10 minutes of ECG recordings in solid state non-volatile memory. The device uses a two-wire lead set for single channel ECG acquisition. Using looping memory, the device captures ECG data; both before and after the patient experiences a cardiac symptom through auto-recording, or manually after the patient presses the RECORD button. ECG events are transmitted later in the form of an FM-modulated acoustic tone, when the SEND button is depressed. The device is configured in a compact sized case.

AI/ML Overview

The provided text describes the "KOH Express AF cardiac event recorder" and outlines its performance validation. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, details on experts, adjudication methods, MRMC study results, or training set information.

The document indicates that "Final testing of the system included various performance tests and software validation tests designed to ensure that the device meets all of its functional and performance requirements and is fit for its intended use." It also states that "Arrhythmia Detection Algorithm Performance Validation" was performed, which implies that the device's ability to detect arrhythmia types (Tachycardia, Bradycardia, Atrial Fibrillation) was evaluated. However, the results of this validation are not provided in the given text.

Therefore, I cannot populate the table or provide specific details for most of the requested information. I can only extract what is explicitly mentioned.

Here's what can be extracted based on the provided text, with "N/A" for information not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated, Inferred from Arrhythmia Detection)	Reported Device Performance
Performance of Tachycardia detection algorithm	N/A (Results not provided)
Performance of Bradycardia detection algorithm	N/A (Results not provided)
Performance of Atrial Fibrillation detection algorithm	N/A (Results not provided)
Functional and performance requirements	Meets (No specific metrics)

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

• Sample Size for Test Set: N/A (Not specified)
• Data Provenance: N/A (Not specified)

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

• Number of Experts: N/A (Not specified)
• Qualifications of Experts: N/A (Not specified)

4. Adjudication method for the test set

• Adjudication Method: N/A (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

• MRMC Study Done: No. The device "records the ECG data and analyzes it for arrhythmias" [page 1]. This implies a standalone algorithm for detection, not an AI assistance tool for human readers.
• Effect Size: N/A

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

• Standalone Performance Study Done: Yes (implied). The text states "Arrhythmia Detection Algorithm Performance Validation" was performed [page 2], and the device "automatically detected" arrhythmias [page 1]. This indicates a standalone algorithmic performance evaluation. However, the specific results are not provided.

7. The type of ground truth used

• Type of Ground Truth: N/A (Not explicitly specified. For "Arrhythmia Detection Algorithm Performance Validation," it would typically be expert-adjudicated ECG tracings, but this is not confirmed in the text).

8. The sample size for the training set

• Sample Size for Training Set: N/A (Not specified)

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

• Ground Truth for Training Set Establishment: N/A (Not specified)

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).