(14 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 updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module.
The provided text describes a 510(k) submission for the Philips Medical Systems, M1275B Component Compact Monitor. This submission is for an updated software and the ability to connect to the Philips M1026A Anesthesia Gas Module, and it aims to demonstrate substantial equivalence to previously cleared devices rather than providing a study for a novel device's acceptance criteria and performance.
Therefore, many of the requested sections about acceptance criteria, detailed study results, sample sizes, expert ground truth establishment, and comparative effectiveness are not available or directly applicable in this context. The document focuses on demonstrating that the updated device meets the specifications of its predicate, not on establishing new performance criteria.
Here's an analysis based on the provided text, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, the specific quantitative acceptance criteria and the detailed reported performance values for each parameter (e.g., accuracy, precision) are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed in the summary. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device." | Not explicitly detailed in the summary. The document states "test results showed substantial equivalence" and "The results demonstrate that Component Compact Monitor meets all reliability requirements and performance claims." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the summary. The text mentions "system level tests, performance tests, and safety testing from hazard analysis" but does not specify the sample size of any test sets or the provenance of any data used for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the summary. As the submission focuses on substantial equivalence to a predicate device and relies on engineering and performance testing based on existing specifications, the concept of "ground truth established by experts" in the context of clinical interpretation (like in imaging or diagnostic AI) is not directly applicable here.
4. Adjudication Method for the Test Set
This information is not provided in the summary. Adjudication methods (like 2+1 or 3+1) are typically used when human interpretation is involved in establishing a ground truth for diagnostic accuracy studies. For this type of device, which is a physiological monitor, the "ground truth" would likely be established through calibrated instruments and established engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted (or at least not mentioned in the summary). This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to measure an effect size. This device is a physiological monitor, and its evaluation focuses on technical performance and equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The evaluation described is inherently a standalone performance assessment of the device against established specifications. The text states: "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." This implies testing the device's technical performance without a human-in-the-loop performance study, as would be typical for a physiological monitor. However, it's not explicitly framed as an "algorithm only" study as if it were an AI diagnostic tool.
7. Type of Ground Truth Used
The ground truth for evaluating this physiological monitor would have been based on:
- Established engineering specifications and standards: Performance parameters (e.g., accuracy of gas measurements, heart rate monitoring) would be verified against known, calibrated inputs or reference devices that serve as the "ground truth."
- Predicate device specifications: The summary explicitly states: "Pass/Fail criteria were based on the specifications cleared for the predicate device." The performance of the predicate device, already deemed safe and effective, serves as the benchmark.
8. Sample Size for the Training Set
This information is not provided in the summary. The device's "updated software" suggests firmware or operating system updates for controlling hardware, not necessarily a machine learning model that requires a "training set" in the typical sense of AI development. If any algorithms within the device were developed using data, the size and nature of such a training set are not mentioned.
9. How Ground Truth for the Training Set Was Established
As no "training set" in the context of AI development is explicitly mentioned or implied for this physiological monitor's updated software, the method for establishing its ground truth is not applicable/provided.
§ 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.