(81 days)
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adult, pediatric and neonatal patients in a hospital environment and during transport inside and outside of hospital environment.
The modified device Philips M3001A Multi Measurement Server is substantially equivalent to the leqally marketed M3001A Multi Measurement Server (K030973, K033715). The modification consists of the integration of the Nellcor OxiMax SpO2 measurement module which is substantially equivalent to the legally marketed Nellcor OxiMax N-600x Pulse Oximeter (K060576). The modification adds to the M3001A Multi Measurement Server the Nellcor OxiMax SpO2 measurement module as an option in order to use the full Nellcor OxiMax technology. The modification is the integration of the Nellcor OxiMax SpO2 measurement module into the M3001A with minor hardware and software adaptations. The modification leads to a compact Multi measurement Server with integrated full Nelloor OxiMax technology.
The provided text describes the Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 measurement module. However, it does not contain a discrete "acceptance criteria" section with specified thresholds for performance metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and adherence to standards.
Here's an attempt to extract and infer information based on the provided text, structured as requested:
Acceptance Criteria and Study Details for Philips M3001A Multi Measurement Server with Nellcor OxiMax SpO2 Measurement Module
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Within specified ranges (conforming to ISO 9919:2005) | 2% to 4% RMS dependent on the Nellcor OxiMax sensor type for specified ranges |
| Pulse Rate Accuracy | Within specified ranges (conforming to ISO 9919:2005) | ±3 bpm in the range of 25 bpm to 250 bpm |
| Functionality | Meets all reliability requirements and performance claims (comparable to predicate device) | "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." |
| Safety | Meets safety requirements (from hazard analysis) | "safety testing from hazard analysis" conducted. |
| Environmental | Withstands environmental conditions (comparable to predicate device) | "environmental tests" conducted. |
| System Level | Performs as expected as a complete system (comparable to predicate device) | "system level tests" conducted. |
| Integration | Seamless integration of SpO2 module (comparable to predicate device) | "integration tests" conducted. |
Note on Acceptance Criteria: The document explicitly states "Pass/Fail criteria were based on the specifications cleared for the predicate device." While specific numerical acceptance criteria other than the accuracy ranges for SpO2 and pulse rate are not provided, it's inferred that the acceptance criteria revolved around demonstrating performance equivalent to the legally marketed predicate devices and compliance with ISO 9919:2005.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "controlled hypoxia studies with healthy non-smoking adult volunteers" for establishing calibration curves, but it does not specify the sample size for the test set used to validate the accuracy of the final device.
- Data Provenance: The SpO2 calibration curves are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The location or country of origin for these volunteers is not specified. The nature of the study for these calibration curves is prospective, as they involve controlled studies. The verification, validation, and testing activities mentioned for the full device are likely internal tests, but no further details on their provenance are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set in the context of the device's performance validation. The SpO2 values are derived from a physiological principle (absorption of light and ratio of oxygenated hemoglobin) and calibrated against in vivo hypoxia studies, not expert interpretation.
4. Adjudication Method for the Test Set
Since there is no mention of experts establishing ground truth or subjective assessments, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device's physiological measurements.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the information provided describes a standalone performance evaluation of the device. The accuracy of SpO2 and pulse rate, and the overall functionality, were tested without explicit human-in-the-loop interaction for interpretation or decision-making related to the device's core measurements. The SpO2 measurement is "based on the absorption of light" and calculated through "Out of calibration curves."
7. Type of Ground Truth Used
The ground truth for the SpO2 measurement accuracy relies on:
- Physiological principle: The definition of SpO2 as the percentage ratio of oxygenated hemoglobin to total hemoglobin.
- Controlled hypoxia studies: Data obtained from "controlled hypoxia studies with healthy non-smoking adult volunteers" was used to establish calibration curves, which then serve as the reference for determining SpO2 values from the light absorption ratio. This implicitly means that the actual blood oxygen levels during these controlled studies served as the ground truth for calibration curve development.
For the general functional and reliability testing, the ground truth was "specifications cleared for the predicate device" and compliance with ISO 9919:2005.
8. Sample Size for the Training Set
The document does not explicitly use the term "training set." However, the "calibration curves" for SpO2 are based on "controlled hypoxia studies with healthy non-smoking adult volunteers." The sample size for these studies (which serve as the basis for the device's internal calibration/training equivalent) is not specified.
9. How the Ground Truth for the Training Set Was Established
The "calibration curves" (analogous to a training set for the SpO2 algorithm) were established using data from "controlled hypoxia studies with healthy non-smoking adult volunteers." In these studies, subjects are typically desaturated under controlled conditions, and their arterial blood oxygen saturation is measured directly using a co-oximeter (considered the gold standard for oxygen saturation in blood), which would serve as the ground truth. The ratio of red and infrared light absorption from the oximeter is then correlated with these direct blood oxygen measurements to create the calibration curves.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).