(91 days)
MAC 5500 HD: The MAC 5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG's, interpretive analysis, vector loops; and can be upgraded to provide software analysis options such as high resolutions signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained. operators in a hospital or medical professional's facility.
MAC 3500: The MAC 3500 ECG Analysis System is intended to acquire, analyze, display, and record resting electrocardiographic information from adult and pediatric populations. Basic systems deliver 3.6. 12, or 15 lead ECG's, including interpretive andlysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
The MAC 5500 HD and MAC 3500 ECG Analysis Systems are designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The devices consist of two basic components: the processing unit and the patient acquisition module. The MAC 5500 HD and MAC 3500 can deliver 3, 6, 12, or 15 lead ECG's, including interpretive analysis and 12 or 15 lead ECG's on full-size reports. In addition MAC 5500 HD can deliver vector loops and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The MAC 5500 HD acquires ECG data using the external CAM HD patient data acquisition module. By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced: MAC 3500 has the patient data acquisition module integrated into the main device. The MAC 5500 HD and MAC 3500 incorporate an alphanumeric keyboard for patient demographics and other data entry, a full VGA graphics and waveform display, an integrated thermal writer and removable data storage. Models provide mains or, for customer convenience, rechargeable battery operation as well as optional transmission and reception of ECG data to and from a central ECG cardiovascular information system via communication links. MAC 5500 HD and MAC 3500 are intended as mobile devices by offering an optional trolley for transporting the equipment but the main units can be separated from the trolley and used as desktop units.
The GE Medical Systems Information Technologies, Inc. K110266 510(k) submission for the MAC 5500 HD and MAC 3500 ECG Analysis Systems does not contain a study that establishes acceptance criteria through performance data specific to these devices.
Instead, the submission relies on the concept of substantial equivalence to a predicate device (K073625 MAC 5500 ECG Analysis System). This means the manufacturer is asserting that the new devices are as safe and effective as a previously cleared device that employed the same fundamental technology.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be directly extracted from this document in the traditional sense of a performance study with defined metrics.
However, I can extract information related to the tests and measures taken to ensure substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implicit via Substantial Equivalence): The devices are considered to have met acceptance criteria if they are found to be "as safe, as effective, and performance is substantially equivalent to the predicate device." There are no specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) provided in this document as acceptance criteria.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided for the MAC 5500 HD and MAC 3500 in this document. The manufacturer states that the devices employ the "same fundamental technology" as the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The document explicitly states: "The subject of this premarket submission, MAC 5500 HD and MAC 3500, did not require clinical studies to support substantial equivalence."
- Data Provenance: Not applicable, as no clinical studies were performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
- Not applicable, as no clinical studies were performed, and thus no ground truth for a test set was established using experts.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical studies were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size:
- No. The document explicitly states that clinical studies were not required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document describes the devices as "ECG Analysis Systems" that acquire, analyze, display, and record ECG signals, including "interpretive analysis." While this implies an algorithmic component, no standalone algorithm performance study is detailed in this submission. The focus is on the substantial equivalence of the entire integrated device.
7. The Type of Ground Truth Used:
- Not applicable, as no clinical studies were performed to establish a new ground truth for these devices. The basis for safety and effectiveness is through comparison to a predicate device.
8. The Sample Size for the Training Set:
- Not applicable. As no de novo algorithmic development or performance study for these specific devices is presented, no training set information is provided.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Summary of Non-Clinical Tests and Quality Assurance Measures Applied:
While no clinical performance studies were conducted, the submission highlights the following measures to demonstrate safety and effectiveness through non-clinical means and quality assurance:
- Compliance with Voluntary Standards: The devices and their applications comply with voluntary standards (detailed in Sections 9, 11, and 17 of the full submission, not provided here).
- Quality Assurance Measures Applied to Development:
- Requirement Definition
- Risk Analysis
- Software Safety Classification
- Technical Review
- Formal Design Review
- Code Inspection
- Integration Testing (Module and System verification)
- Final Acceptance Testing
- Performance Testing
- Safety Testing
§ 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).