(133 days)
The Biolog™ 3000 electrocardiograph detects an ECG using a single lead patient cable or alternatively can receive ECG data detected by the Micromedical™ 12 Lead Simultaneous Cable. The Biolog™ 3000 electrocardiograph can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running CardioView™ 3000 software or to the Micromedical™ Printer Interface. The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices.
The proposed device is an electrocardiograph that can record the ECG, display the ECG signal on a built-in LCD screen, and download the recorded ECG data to a PC running Cardio View7M 3000 software or to a Micromedical™ monitor to display the ECG signal on a personal computer. The device includes a Biolog™ 3000 unit, a User's Manual, and accessories.
This 510(k) summary for the Biolog™ 3000 electrocardiograph does not contain detailed acceptance criteria or a study proving the device meets those criteria. The provided text is a summary of the 510(k) submission, focusing on establishing substantial equivalence to a predicate device.
Here's an breakdown of the requested information based on the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Nonclinical testing was performed to compare the device to the predicate device."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No, an MRMC study is not mentioned as having been performed. The safety and effectiveness are established through substantial equivalence to a predicate device based on nonclinical testing.
- Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no MRMC study or AI assistance aspect is mentioned.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: Yes, in a limited sense. The "Nonclinical testing" conducted appears to be a standalone evaluation of the device's technical performance against the predicate. However, detailed metrics of this performance are not provided. The statement "The device contains proprietary software algorithms to detect an ECG signal or receive ECG data from a patient cable, remove unwanted interference from the ECG signal, store the signal into memory, and download it to peripheral devices" implies algorithm functionality was tested.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. Given it's an ECG device, the "ground truth" for nonclinical testing would likely be derived from a controlled signal generator or established reference ECG readings, used to confirm the device's ability to accurately detect, process, and display ECG signals compared to the predicate device.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. The document does not explicitly mention a training set, which would typically be associated with machine learning or AI models undergoing supervised training. While the device contains "proprietary software algorithms," the documentation doesn't detail their development or training methodology.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified, as a training set is not explicitly mentioned.
Summary of Information Provided:
The 510(k) summary for the Biolog™ 3000 electrocardiograph primarily focuses on establishing "substantial equivalence" to a predicate device (MAX 1 Exercise Testing System) through "nonclinical testing." It does not provide specific details on acceptance criteria, test set specifics (sample size, data provenance), expert involvement, adjudication methods, or the results of detailed performance studies as would be expected for an AI/ML-based device with comprehensive performance claims. The "proprietary software algorithms" are mentioned for detecting, filtering, storing, and downloading ECG data, but their validation process in terms of statistical metrics or clinical studies is not elaborated upon in this summary.
§ 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).