(14 days)
The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations.
The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
The physiological parameters monitored include ECG, non-invasive blood pressure and SpO2. The ApexPro Telemetry System is intended to provide ECG data via Ethernet to the computer platform for processing. The ApexPro is also intended to provide physiologic data over the Unity network to clinical information systems for display.
The ApexPro Telemetry System is composed of six major components:
- The patient worn data acquisition transmitters
- The receiver antenna system infrastructure
- The receivers
- The receiver subsystem
- A computer platform running the ApexPro Telemetry Application
- A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)
The provided regulatory submission (K032369) for the ApexPro Telemetry System does not contain the detailed information required to fill out the requested table and study specifics regarding acceptance criteria and performance against those criteria.
The document is a 510(k) summary and the FDA's clearance letter. It primarily states that the device is "as safe, as effective, and performs as well as the predicate devices" (K021325 ApexPro Telemetry System) and "complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 (which would likely contain the standards and test data) is not included in the provided text.
Based on the provided text, here's what can be extracted and what is missing:
Information NOT available in the provided text:
- Specific Acceptance Criteria (quantitative thresholds for performance).
- Reported Device Performance (quantitative results against acceptance criteria).
- Details of the study that proves the device meets acceptance criteria. This includes:
- Sample size for the test set and its provenance.
- Number of experts for ground truth and their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Information AVAILABLE from the provided text:
The "Test Summary" section mentions the types of quality assurance measures applied, but these are general development and testing practices, not specific performance study details:
- Requirements specification review
- Code inspections
- Software and hardware testing
- Safety testing
- Environmental testing
- Final validation
The "Conclusion" states: "The results of these measurements demonstrated that the ApexPro System is as safe, as effective, and performs as well as the predicate devices." This is a qualitative statement of equivalence, not a quantitative report of performance against specific criteria.
Therefore, I cannot populate the table or provide the detailed study information as requested, as that specific data is not present in the provided FDA submission excerpts. The submission relies on demonstrating substantial equivalence to a predicate device and adherence to voluntary standards, rather than providing a detailed performance study with specific acceptance criteria and results within this summary document.
To answer your request thoroughly, I would need access to "Section 9 of this submission" or specific test reports from GE Medical Systems Information Technologies for K032369.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.