(444 days)
The Medicalgorithmics' Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient's ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch's memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
The FDA 510(k) clearance document for the Q Patch (K210758) indicates that a clinical study and other performance tests were conducted to demonstrate substantial equivalence to the predicate device. However, the document does not contain a specific table of acceptance criteria and reported device performance metrics in numerical form (e.g., sensitivity, specificity, accuracy) for an algorithm's performance in detecting arrhythmias. This is largely because the Q Patch is described as an "Electrocardiograph, Ambulatory (Without Analysis)," meaning it primarily records ECG data and does not perform automated arrhythmia analysis.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not provide a table with quantitative acceptance criteria and specific algorithm performance metrics for arrhythmia detection (e.g., sensitivity, specificity). The Q Patch is explicitly stated not to include ECG analysis and visualization software as part of this specific product's clearance. It functions as a recorder, and its data can be integrated with third-party analysis software.
The acceptance criteria are implicitly defined by compliance with relevant electrical safety, EMC, software, usability, and biocompatibility standards, and demonstrating comparable performance to the predicate device in ECG recording quality.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Compliant with ANSI AAMI ES60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012 (Consolidated Text) |
| EMC | Compliant with ANSI AAMI IEC 60601-1-2:2014 |
| Software V&V | Conducted and documentation provided, considered Moderate Level of Concern for Q Patch device; Minor Level of Concern for Q Patch Mobile Application and Downloader. |
| Usability Engineering | Applied FDA Guidance (February 3, 2016), IEC 60601-1-6 Edition 3.1 2013-10, ANSI AAMI IEC 62366-1:2015. |
| Biocompatibility | Compliant with FDA Guidance for Use of International Standard ISO 10993-1 (Sept 4, 2020) and ISO 10993-1 Fifth edition 2018-08 (Cytotoxicity, Sensitization, Irritation). |
| Adherence to Patient's Skin | Study with 18 participants proved standard off-the-shelf Ag/AgCl electrodes can be used for up to 15 days. |
| ECG Signal Quality (Clinical Study) | No clinically significant differences in performance compared to a reference device. Non-standard ECG lead recorded found appropriate for human interpretation. |
2. Sample Size Used for the Test Set and Data Provenance
-
Clinical Study for ECG Signal Quality:
- Sample Size: 30 participants.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It mentions "Clinical study where ECG signals were recorded by the subject device and reference device simultaneously have been performed," which suggests a prospective data collection.
-
Electrode Adherence Study:
- Sample Size: 18 participants.
-
Usability Testing:
- Sample Size: 60 participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the clinical study on ECG signal quality:
- The document states: "It has been demonstrated that non-standard ECG lead recorded by the Q Patch device is appropriate for ECG evaluation performed by the trained human interpreter."
- It further clarifies: "Potential patient cardiac abnormalities, must be confirmed by a qualified ECG technician or by a physician with other relevant clinical information."
- The number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified in the provided text for establishing ground truth within the clinical study. It generally refers to "trained human interpreter," "qualified ECG technician," or "physician."
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC study involving AI assistance: The document states that "The subject device acquires ECG data and does not perform automatic arrhythmia analysis." Therefore, a comparative effectiveness study involving AI assistance for human readers is not applicable as the cleared device does not have an AI analysis component.
- The clinical study compared the Q Patch's ECG signal quality against a "reference device" for human interpretation, not with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone algorithm performance study: As the device "does not perform automatic arrhythmia analysis," a standalone algorithm performance study is not applicable. The device's primary function is ECG recording.
7. The Type of Ground Truth Used
- For the ECG signal quality clinical study: The ground truth appears to be based on human interpretation of the ECG signals by "trained human interpreter," "qualified ECG technician," or "physician," potentially against findings from a "reference device." This implies a form of expert consensus or comparison to a gold standard from the reference device, though specific details are lacking.
8. The Sample Size for the Training Set
- The document does not indicate any training set as the Q Patch "does not perform automatic arrhythmia analysis" and is not an AI/algorithm-based diagnostic device. The studies described are for hardware performance, signal quality, usability, and biocompatibility.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for an algorithm.
§ 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).