(111 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Philips MP5 and MP5T IntelliVue Patient Monitors and Philips TRx4841A IntelliVue Telemetry System Transceiver. The modification is a change that adds wireless connection between the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver as an alternative to the existing cable connection.
The provided text describes a 510(k) summary for the Philips MP5 and MP5T IntelliVue Patient Monitors and the Philips TRx4841A IntelliVue Telemetry System Transceiver. The modification described is adding wireless connectivity as an alternative to existing cable connection.
However, the summary does not contain detailed information about specific acceptance criteria or an analytical study with quantitative results, sample sizes, expert involvement, or adjudication methods as typically found in comprehensive clinical validation reports for AI/CAD devices. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than a de novo validation of new performance claims for detection or diagnosis.
Here's a breakdown of what can be extracted and what is missing based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs the same intended functions as predicate devices. | "Testing involved system level tests... The results successfully demonstrate that [the modified devices] meet all reliability requirements and performance claims." |
| Safety: Device operates safely. | "Testing involved...safety...tests." |
| EMC (Electromagnetic Compatibility): Device meets EMC standards. | "Testing involved...EMC...tests." |
| Performance: Device meets performance specifications. | "Testing involved...performance...tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results showed substantial equivalence." |
| Reliability: Device is reliable in operation. | "The results successfully demonstrate that [the modified devices] meet all reliability requirements..." |
| Environmental: Device performs as expected in various environments. | "Testing involved...environmental...tests." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "system level tests, safety, EMC, performance, environmental and functionality tests" were involved, but no details on sample size (e.g., number of patients, number of readings/events) are provided for these tests.
- Data Provenance: Not specified. It's implied that the testing was conducted internally by Philips Medizin Systeme Boeblingen GmbH. No mention of country of origin of data or whether it was retrospective or prospective is given.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable/Not specified. Since this is a device modification for connectivity and not a new diagnostic or detection algorithm, the concept of "ground truth" established by experts in the context of clinical accuracy (e.g., for disease detection) is not explicitly relevant or reported here. The "pass/fail criteria" were based on existing predicate device specifications.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified. No adjudication method is mentioned, as the testing appears to be primarily technical and functional rather than expert-driven clinical assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is typically performed to evaluate the impact of an AI algorithm on human reader performance, usually for diagnostic tasks. This submission is for a monitor connectivity modification and does not involve AI/CAD features that would necessitate an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not directly applicable in the terms of an "algorithm" for diagnosis. The device itself (monitor and telemetry system) performs functions (like arrhythmia detection, ST segment monitoring as per the regulation names), but the modification here is about wireless connection. The existing functions were "substantially equivalent" to predicate devices. The "standalone performance" was assessed through various engineering and functional tests.
7. The Type of Ground Truth Used:
- The "ground truth" for this type of submission refers to the established specifications and performance of the predicate devices. The modified device's performance was compared against these pre-defined benchmarks. The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate devices."
8. The Sample Size for the Training Set:
- Not applicable/Not specified. This submission is for a hardware modification (wireless connectivity) of an existing monitor system, not a new AI/machine learning algorithm requiring a training set in the typical sense.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not specified, as there is no mention of a "training set" in the context of artificial intelligence.
In summary: This 510(k) pertains to a hardware modification (wireless connectivity) for an existing medical device, not a new AI-powered diagnostic tool. The "study" described is a series of verification and validation tests to ensure the modified device maintains functional equivalence, safety, and performance as compared to its legally marketed predicate devices, with acceptance criteria based on the predicate device's established specifications. The document lacks the detailed clinical study data often associated with new diagnostic algorithms.
§ 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.