(71 days)
The use of Voyager 12 is indicated when it is desired to record and interpret an electrocardiogram of a patient. This includes a resting electrocardiogram and a rhythm electrocardiogram.
Voyager 12 is a 12-lead digital electrocardiograph with interpretation of the electrocardiogram. Voyager 12 is a portable, self-contained unit with an internal printer. It permits either manual or automatic interpretation of electrocardiograms.
Here's a breakdown of the acceptance criteria and study information for the Del Mar Reynolds Medical Voyager 12, based on the provided text:
No clinical studies were performed for the Del Mar Reynolds Medical Voyager 12 for its 510(k) submission. The submission states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."
Therefore, many of the requested categories regarding clinical study details cannot be filled as they are not applicable to this specific submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical performance data is provided for the Voyager 12 itself, and the submission relies on substantial equivalence to predicate devices, specific acceptance criteria in terms of clinical performance metrics are not detailed in the provided text. The "acceptance criteria" here would primarily relate to meeting recognized electrical and safety standards and demonstrating technological similarity to predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety Standard | Met IEC 60601-1 |
| Specific ECG Standard | Met IEC 60601-2-25 |
| Specific ECG Standard | Met IEC 60601-2-51 |
| Electromagnetic Compatibility (EMC) | Met IEC 60601-1-2 |
| Functionality | Passed "Validation tests" (details not provided) |
| Clinical Performance | Not applicable; demonstrated substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used for the Voyager 12's 510(k) submission. The device's performance was not evaluated through a separate clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set required ground truth establishment by experts for this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not performed. The submission explicitly states: "Clinical tests are not necessary since Voyager 12 uses the same technology as the predicate device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable in the context of a standalone clinical performance study. While the device does have automated interpretation, its performance in this regard was not tested in a standalone clinical trial for this 510(k) submission. Instead, it relies on the predicate device's established performance.
7. The Type of Ground Truth Used
Not applicable for a clinical performance study. For the non-clinical tests, the "ground truth" would be the successful adherence to the standards listed (e.g., meeting specific electrical parameters, signal quality benchmarks defined by the IEC standards).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that undergoes a training phase with a specific dataset in the way modern AI devices do. Its "interpretation" functionality likely derives from fixed algorithms or rule-based systems, or algorithms validated with prior data by the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable due to the reasons stated in point 8.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).