(219 days)
The Masimo Disposable Ear Sensors are indicated for single patient use for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (measured by an monitoring of tansitional Drygol and pediatric patients, (weighing >30kg), who are well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo Disposable Ear Oximetry Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
The E1 Sensors and the predicates (K012992) Masimo Reuseable Ear Sensor (LNOP Sensor) and (K051212) the LNCS Reusable Ear Sensor (LNCS Sensor) have similar indications for use/ intended use. The main difference is that the E1 Sensors are disposable ear sensors.
Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Masimo Disposable Oximetry Ear Sensors:
1. Table of Acceptance Criteria and Reported Device Performance
| Measurement | Acceptance Criteria (Accuracy Range) | Acceptance Criteria (Accuracy) | Reported Device Performance (Table states "Accuracy") |
|---|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | ± 3.5% | ± 3.5% (The text states the specifications for the E1 Sensors are "as following" and then lists these values under "Accuracy". This implies these are the reported performance values that meet the criteria.) |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | ± 3.5% | ± 3.5% |
| Pulse Rate, No Motion | 25-240 bpm | ± 3 bpm | ± 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | ± 3 bpm | ± 3 bpm |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance Testing" was applied to the development of the E1 Sensors and that "The E1 Sensors have been validated to the Masimo SET Technology."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document describes a sensor for continuous non-invasive monitoring of physiological parameters (SpO2 and pulse rate). This is a direct measurement device and not an AI-assisted diagnostic tool that would involve "human readers" or an MRMC study in the context of improving human interpretation. Therefore, an MRMC comparative effectiveness study was not applicable and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The "Specifications" section directly lists the accuracy of the E1 Sensors for SpO2 and Pulse Rate measurements, which are inherent performance characteristics of the device itself, independent of human interpretation or intervention during measurement. The validation was against "Masimo SET Technology," implying a direct comparison to an established measurement standard rather than human-in-the-loop performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for performance validation was likely established through comparison with Masimo SET Technology, which itself would be validated against a recognized gold standard for oxygen saturation and pulse rate measurement (e.g., blood gas analysis for SpO2). However, the specific method for establishing this ground truth (e.g., clinical study with arterial blood gas draws) is not detailed in this summary.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" as this device is a sensor for direct measurement and not a machine learning algorithm that typically requires a distinct training phase. The validation stated is against "Masimo SET Technology."
9. How the Ground Truth for the Training Set was Established
As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided information. The device's performance is validated against an established technology (Masimo SET Technology), which would have its own validated ground truth.
§ 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).