(64 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters patients.
Intended use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in health care facilities.
EASI 12-lead ECG is only for use on adult and pediatric patients.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp02 / tcpCO2) is restricted to neonatal patients only.
The name of this device is the Philips Medical Systems, M1275B Component Compact Monitor. The modification is a new display unit and a modified rack.
The M1275B Component Compact Monitor does not contain AI and is thus not an AI/ML powered device. Hence the information requested will not be available in the provided document.
However, the document does contain information about the device's acceptance criteria and the study conducted to prove its compliance in a general sense.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pass/Fail criteria based on specifications cleared for the predicate device. | Test results showed substantial equivalence. The results demonstrate that the Component Compact Monitor meets all reliability requirements and performance claims. |
2. Sample Sizes and Data Provenance:
- Test Set Sample Size: Not specified. The document states "Testing involved the new device, performance tests, and safety testing from hazard analysis." It does not provide details on the number of devices or scenarios used for these tests.
- Data Provenance: Not explicitly stated but implied to be from internal testing conducted by Philips Medical Systems in Andover, MA, USA. It is a prospective study as it involved testing a new device.
3. Number of Experts and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The testing would likely have been conducted by engineers and quality assurance personnel at Philips Medical Systems.
4. Adjudication Method:
- Not applicable as this is not a study involving human interpretation of data for ground truth establishment. The testing would have followed established engineering and quality assurance protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI/ML powered device and therefore no MRMC study would be conducted to assess human reader improvement with AI assistance.
6. Standalone Performance Study:
- Yes, a standalone performance study was conducted. The document states "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. Testing involved the new device, performance tests, and safety testing from hazard analysis." This refers to testing the device itself, without human-in-the-loop performance assessment.
7. Type of Ground Truth Used:
- The ground truth in this context is the specifications and performance characteristics of the legally marketed predicate device. The new device's performance was measured against these established standards.
8. Sample Size for Training Set:
- Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How Ground Truth for Training Set Was Established:
- Not applicable.
§ 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.