(63 days)
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:
– Dizziness
- Heart race
- Palpitations
- Syncopes of unknown cause
The Vitaphone 100 BT device is single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as REMOS ECG Receiving Software (510(k) K050670) or compatible ECG receivers.
The Vitaphone 100 BT device is intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time.
This 510(k) submission for the Vitasystems GmbH Post-Event Recorder Vitaphone 100 BT focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics in the way a novel AI algorithm would.
Therefore, many of the requested categories regarding acceptance criteria, study design, and performance metrics are not applicable or cannot be extracted directly from this document. This submission relies on proving the new device performs similarly to
already approved devices under established safety and performance standards.
Here's an breakdown of the available information based on your request, with an explanation of why some sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a specific table of acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy, F1 score) that would be relevant for an AI/CADe device. Instead, the "acceptance criteria" for this type of device are centered around meeting established safety and performance standards for electrophysiological equipment and demonstrating substantial equivalence to predicate devices.
Acceptance Criteria (Implied from the 510(k) and applicable standards):
| Acceptance Criteria Category | Vitaphone 100 BT Performance/Evidence |
|---|---|
| Safety and Electrical Performance | Compliance with:EN 60601-1:2006 (General Requirements for Safety)EN 60601-1-2:2007 (Electromagnetic compatibility)E DIN IEC 60601-2-47:2008 (Safety and essential performance of ambulatory ECG systems) |
| Biological Compatibility | Compliance with:ISO 10993-1:2003 (Biological Evaluation of Medical Devices) |
| Risk Management | Compliance with:ISO 14971:2007 (Application of risk management to medical devices) |
| Quality Management System | Compliance with:ISO 13485:2007 (Quality management systems) |
| Functional Equivalence | "The operation of the Vitaphone 100 BT shows a safe and reliable means for recording and transmission of patient ECG parameters and no adverse health effect or safety risk to patients when used as intended." (This is a summary statement of functional equivalence to predicate devices for its intended use as a cardiac event recorder transmitting ECGs to compatible receiving systems.) |
| Intended Use | The device successfully performs its intended use: "single-channel cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system... intended for patient activated event recordings. It is battery driven and utilizes a Flash memory to store ECG data with an adjustable event time." This aligns with the capabilities of the predicate devices. |
| Substantial Equivalence | Demonstrated through comparison with Vitaphone 3100 BT (K053378) and PMP4 SelfCheck ECG (K042254), implying similar technological characteristics and performance in recording and transmitting ECG data. |
2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a hardware device (cardiac event recorder) that records and transmits ECGs. It does not involve a "test set" of data for diagnostic performance evaluation of an algorithm in the way an AI/CADe device would. The evaluation is against engineering standards and comparison to predicate devices, not against a clinical dataset for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As above, there is no "test set" requiring ground truth establishment by experts for diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication in this context.
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
- Not Applicable. This is a standalone device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device for recording and transmitting ECGs. While its function implicitly involves "sensing" and "recording," it is not an "algorithm only" device in the AI sense, nor does it perform automated diagnosis. Its "standalone performance" is related to its ability to accurately capture and transmit ECG signals, which is assessed through compliance with technical standards rather than an algorithmic evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a device of this nature, the "ground truth" would relate to the accuracy of its electrical measurements and data transmission properties, verified against calibrated equipment and engineering specifications, rather than clinical ground truth like pathology or expert consensus on a diagnosis.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this type of device.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).