(69 days)
The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.
Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study with statistical results proving the device meets said criteria for the "Easyrode Disposal ECG Electrodes, Model Easyrode." The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics.
However, based on the information provided, here's what can be extracted and inferred regarding the "acceptance criteria" and "study":
The "acceptance criteria" in this context are primarily informal, focusing on demonstrating that the Easyrode performs "as well as" the predicate device in fundamental ECG monitoring functionalities and meets general safety and effectiveness standards for such devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Safe and effective for ECG monitoring. | The conclusion states: "The results of these measurements demonstrated that the Easyrode is as safe, as effective, and performs as well as the predicate device." This is a qualitative statement of equivalence. No specific quantitative performance metrics (e.g., impedance, signal-to-noise ratio, artifact levels) are provided in the summary. The comparison focuses on similar intended use and general technological characteristics. |
| Suitable for short-term and long-term (up to 2 days) monitoring. | Easyrode: Intended for use in ECG Monitoring, for short-term and long-term (2 Days) monitoring. This matches the intended use of the predicate devices. Predicate device (3M Red Dot 2560): Used for short time and long time (2 day). The document explicitly states "Easyrode is used for 2day and below," confirming alignment with the predicate's duration of use. |
| Functional equivalence to predicate device in ECG applications. | The device description and intended use state: "The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used." Under "Technological Characteristics," it indicates both Easyrode and the predicate are "Used for short time and long time (up to 2day)." The primary difference noted is the material (Non-woven tape for Easyrode vs. Foam tape for predicate), with the claim that "Non-woven is allow air pass through easily than foam. That means non-woven is more adhesive to patient skin." This implies performance is at least equivalent, potentially better in adhesion for the Easyrode, without compromising ECG signal quality or patient safety. The approval letter confirms "substantially equivalent." |
| Meets general requirements for disposable ECG electrodes. | This is implicitly met through the 510(k) clearance process, which reviews if the device adheres to general controls, including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. |
Study Information (Based on Available Text):
The document does not describe a clinical trial or a specific standalone study with statistical results to prove performance against pre-defined acceptance criteria in the way one might expect for a novel device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "study" mentioned abstractly ("The results of these measurements demonstrated...") refers to comparative testing and analysis against the predicate device to support this equivalence. No details of these "measurements" are provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "The results of these measurements," implying some form of testing was done, but no specifics on the number of electrodes tested, number of subjects, or duration of testing are provided.
- Data Provenance: Not specified. The manufacturer is based in Japan (SUZUKEN CO, LTD.). The context implies tests were likely conducted by the manufacturer or on their behalf, but the location and whether it was retrospective or prospective data are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided. Given the nature of a 510(k) for an ECG electrode, ground truth likely pertains to technical performance measurements (e.g., impedance, adhesion, signal quality) rather than expert clinical interpretation of ECGs produced by the electrodes. If human evaluation was part of the "measurements," no details are included.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. There is no mention of a human adjudication process for establishing ground truth, as the 'measurements' likely pertain to technical specifications rather than diagnostic output requiring clinical consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is typically associated with diagnostic imaging or interpretation where multiple readers evaluate medical cases. This type of study is not relevant or described for a disposable ECG electrode, which is a physical component, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable/No. This device is a passive, disposable ECG electrode. It does not involve an algorithm or AI. Performance is inherently "standalone" in the sense that it's the electrode's physical properties being measured, but not an algorithm's.
7. The Type of Ground Truth Used
- Inferred Technical Performance Data/Comparison to Predicate: The "ground truth" (or basis for comparison) was the performance characteristics of the legally marketed predicate device (3M Red Dot 2560 Monitoring Electrode). "Measurements" were conducted to demonstrate that the Easyrode performs "as safe, as effective, and performs as well as" the predicate. This would typically involve measuring electrical characteristics (e.g., impedance, DC offset, AC impedance, defibrillation recovery), adhesion properties, and biocompatibility, all compared against established standards or the predicate's known performance. No specific details on which data types were collected are in the summary.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device (an electrode), not an AI algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a physical device, this question is not relevant.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.