(186 days)
The myPatch is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, presyncope, syncope, fatigue, chest pain and/or anxiety.
The myPatch ambulatory electrocardiograph(ECG) recorder is a small, lightweight monitor that records ECG continuously. The unit records 2 channel of ECG data up to 3 days. The device is composed of a large ECG electrode and ECG recorder. The ECG recorder clips onto the electrode and records until the recorder is removed from the electrode. At the end of the recorder can be plugged into a PC via the USB connection. The ECG recording can be transferred in an available file that can be processed through recording processing software provided by recording processing software manufacturers and analyzed by qualified healthcare providers.
The myPatch records ECG in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders.
During the recording the patient wears the myPatch connected to an electrode on the sternym. The myPatch consists of a plastic casing containing a battery and electronics consisting of a microprocessor, measuring circult, memory, data storage, light-emitting dlode (transilluminates the plastic casing), and contact to the electrode. In addition to that, myPatch contains firmware to control the collection of the ECG-data and software to transfer to processing software.
The battery is a rechargeable lithium polymer battery with a built-in protection circuit. The charging of the myPatch is by use of a USB cable, which can only be connected to myPatch when it is not connected to the electrode. At the bottom of myPatch is an electrical and click-on connection for the electrode. myPatch must be connected to the electrode to turn on and to acquire data. myPatch has a serial number to secure the traceability of the equipment and the data during and after the investigation. myPatch is reusable.
The electrode ( accessory to myPatch, ) is the passive part. The electrode consists of one layer of onesided adhesive tape that runs the full length of the electrode. This adhesive tape allows the electrode to be placed on the sternum. The electrode gel is placed on the underneath side of the adhesive tape. Through this electrode gel, the ECG of the patient is measured. The top side of the electrode has an electrical and click-on connection to myPatch. The conductor paths are printed on the adhesive tape. These conductor paths make the connection between the electrode gel on the underside and the connection to myPatch on the top side of the electrode.
Release liners are placed on the underside and on the top side of the electrode. These release liners cover the adhesive tape and the electrode gel and are torn off when placing the myPatch on the sternum. The electrode has to be connected to myPatch to have any practical use. The electrode is a single- use device and is disposed of after one single use.
This document is a 510(k) summary for the myPatch Ambulatory ECG Recorder (Model #: Amors1000). It outlines the device's description, indications for use, and a list of standards it meets, which are typically used to demonstrate substantial equivalence to predicate devices. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: The document does not explicitly define specific performance-based acceptance criteria (e.g., sensitivity, specificity for arrhythmia detection). Instead, the acceptance criteria are demonstrated by compliance with various international standards for medical electrical equipment.
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Reported Device Performance: Clinical performance data is not provided in this 510(k) summary. The document states that "All testing demonstrated acceptable results" for various electrical and safety standards, but no quantitative performance metrics for ECG recording accuracy or diagnostic capabilities are presented.
Acceptance Criterion (standard compliance) Reported Device Performance IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) / IEC 60601-1/A11:2011 (General requirements for basic safety and essential performance) "All testing demonstrated acceptable results" EN 60601-1-11: 2010 (Home healthcare environment requirements) "All testing demonstrated acceptable results" IEC 60601-2-47: 2012 (Particular requirements for ambulatory electrocardiographic systems, equivalent to ANSI/AAMI EC38) "All testing demonstrated acceptable results" and "myPatch has met the design verification testing standards as set forth in IEC 60601-2-47" EN 60601-1-2:2007 (Electromagnetic compatibility) "All testing demonstrated acceptable results" EN 62366:2008 (Application of usability engineering to medical devices) "All testing demonstrated acceptable results" EN 1041:2009 (Information supplied by the manufacturer) "All testing demonstrated acceptable results" EN 980:2008 / EN 980 Bil.1:2008 (Symbols for use in labeling) "All testing demonstrated acceptable results" ISO 15223-1:2012 (Medical devices - Symbols for labels) "All testing demonstrated acceptable results" CE Marking (EU guidelines for medical devices) "The myPatch ECG Recorder has the CE Marking (CE 1008). The CE Mark is a statement that the myPatch ECG Recorder fulfills the guidelines established by the EU for medical devices."
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "testing" but does not detail sample sizes for any performance evaluation beyond compliance with engineering standards.
- Data Provenance: Not specified. Given the nature of the testing mentioned (compliance with standards), it likely refers to laboratory-based engineering and electrical testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document focuses on compliance with technical standards, not on clinical performance evaluated against expert-established ground truth.
4. Adjudication method for the test set
- This information is not provided. As clinical performance evaluation is not detailed, adjudication methods are not relevant here.
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 was done or reported. The device is an ECG recorder, not an AI-assisted interpretation system. There is no mention of AI in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" performance. The device is a data acquisition tool. Its standalone performance is in recording ECG data, which is confirmed by compliance with relevant standards (e.g., IEC 60601-2-47). The document affirms that the device records "in accordance to the standard IEC 60601-2-47:2012 for ambulatory ECG recorders."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the engineering and safety tests would be the specifications and requirements defined within the cited IEC/EN/ISO standards. For example, for "Electromagnetic compatibility," the ground truth would be the permissible emission and immunity levels defined in EN 60601-1-2. There is no clinical ground truth discussed.
8. The sample size for the training set
- Not applicable. This device is an ECG recorder, and the document does not mention any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. As no training set for an algorithm is mentioned, the method for establishing its ground truth is irrelevant.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through compliance with international safety and electrical performance standards for medical devices. It does not present clinical performance data, diagnostic accuracy metrics, or AI algorithm validation studies that would involve a test set, ground truth established by experts, or training sets.
§ 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).