(34 days)
The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report.
The IOmark Digital Holter is intended to be used only by physicians or on the order of a physician.
The intended use of the IOmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).
The IOmark Digital Holter is a software program that analyzes recorded ambulatory ECG (Holter) then creates statistical reports based on analyzed data. The ambulatory ECG, as well as pacemaker pulse detection data, is pre-recorded onto data storage mediums by Holter recorders. The IQmark Digital Holter software reads these raw data into computers then performs analysis to generate statistical reports.
The IQmark Digital Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis results to diagnose patients. The IQmark Digital Holter software does not provide diagnostic interpretation.
The IQmark Digital Holter software also provides statistical results of pacing events for pacemaker patients. Like other features in the software, Holter scanning operators can review and edit, if necessary, any analysis results.
The provided 510(k) summary for the IQmark Digital Holter (K031466) primarily focuses on demonstrating substantial equivalence to a predicate device (Rhythmscan Precision 6000, K914577), rather than presenting a detailed study with explicit acceptance criteria and performance data for the IQmark Digital Holter itself.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement are not explicitly stated in the provided document. The 510(k) process for this device relies on the existing clearance of the predicate device and asserts that the changes in the IQmark Digital Holter do not alter the fundamental scientific technology or intended use.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for the IQmark Digital Holter's performance. The primary "acceptance" is based on demonstrating substantial equivalence to the predicate device, Rhythmscan Precision 6000 (K914577), by showing that its intended use and fundamental scientific technology have not changed.
Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) are presented for the IQmark Digital Holter. The document states that "Both devices generate statistical results based on an identical set of analysis results" and that the modified software "has not changed the fundamental scientific technology of the device." This implies that the performance is considered equivalent to the predicate device without needing re-validation of specific metrics for the new device.
| Metric (Implied) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Unchanged from predicate device (Rhythmscan Precision 6000) | "The intended use of the IQmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577)." |
| Fundamental Scientific Technology | Unchanged from predicate device | "The modified Holter software has not changed the intended use of the device and has not changed the fundamental scientific technology of the device." |
| ECG Analysis Capabilities (e.g., heartbeat categories, ST segment, R-R variability) | Identical to predicate device | "Both devices have identical heartbeat categories: Ventricular Ectopics, Supraventricular Ectopics, Asystole (Pause) events and Normal heartbeats. Both devices generate statistical results based on an identical set of analysis results." |
| Pacemaker Evaluation (for IQmark Digital Holter) | Functional and reviewable by operators | "The IQmark Digital Holter software also provides statistical results of pacing events for pacemaker patients. Like other features in the software, Holter scanning operators can review and edit, if necessary, any analysis results." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a distinct "test set" and corresponding sample size for evaluating the IQmark Digital Holter's performance as a standalone product. The submission relies on the substantial equivalence to the predicate device, implying that the predicate's performance, which was presumably validated using appropriate data, is considered applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as a specific "test set" for the IQmark Digital Holter with associated ground truth established by experts is not described in this 510(k) summary. The document mentions that "intended users are expected to review the report" and "Physicians or scanning operators can use provided review and editing tools to verify ECG strips in all categories as well as their measurements and statistics," indicating that human expertise is part of the clinical workflow, but not establishing a ground truth for a performance study within this submission.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as a specific "test set" requiring adjudication for ground truth establishment is not 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
No MRMC study is mentioned or implied. The device is described as an analysis software that provides statistical reports, which are then reviewed and edited by "trained medical personnel" or "physicians or scanning operators." It's not presented as an AI-powered diagnostic aid that improves human reader performance in a controlled study scenario. The core functionality is automated analysis followed by human review/editing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device performs automated analysis and generates statistical reports, the document explicitly states:
- "The IQmark Digital Holter software does not provide diagnostic interpretation."
- "The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report."
- "Physicians or scanning operators can use provided review and editing tools to verify ECG strips in all categories as well as their measurements and statistics."
This strongly indicates that the device's performance is intended to be used with human-in-the-loop review and editing, and no standalone performance study without human intervention is described as part of this 510(k) submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
No specific ground truth type is mentioned because a dedicated independent performance study for the IQmark Digital Holter is not described. The presumption is that the predicate device's performance was established using appropriate ground truth, likely expert interpretation of ECGs, given the nature of Holter analysis.
8. The Sample Size for the Training Set
Not applicable. The document does not describe a machine learning algorithm or a "training set" in the context of this 510(k) summary. The device is a "software program that analyzes recorded ambulatory ECG (Holter)" and is based on the "fundamental scientific technology" of its predicate. This suggests a rule-based or conventional signal processing algorithm rather than a data-driven machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or machine learning algorithm requiring such ground truth is mentioned.
§ 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).