(85 days)
The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during both no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
The Masimo Resposable Oximetry Sensors (S2 Sensors) are fully compatible for use with instruments which include or compatible with the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
- · Philips FAST-SpO2 technology
The S2 Sensors and the predicates (K051212), the LNCS Oximetry Sensors (LNCS Sensors), have the same indications for use/ intended use. The S2 Sensors also have the same sensor design as the predicates (K090165), the Masimo Rainbow Resposable Sensor (R2 Sensors). The reason for this filing is to modify the LNCS Sensor design.
The Masimo Resposable Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The study summarized in this 510(k) evaluates the performance of the device against established accuracy ranges for SpO2 and pulse rate under various conditions.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are defined by the "Accuracy Range" columns in the tables below for each measurement type and technology. The "Accuracy" column represents the reported device performance, indicating the maximum deviation from the true value.
Masimo SET Technology and Masimo Rainbow SET Technology (Adults > 30kg, Pediatrics 10-50kg)
| Measurement | Accuracy Range | Reported Accuracy |
|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | ± 2% |
| Arterial Oxygen Saturation (SpO2), Motion | 70-100% | ± 3% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | ± 2% |
| Pulse Rate, No Motion | 25-240 bpm | ± 3 bpm |
| Pulse Rate, Motion | 25-240 bpm | ± 5 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | ± 3 bpm |
Nellcor Technology and Philips FAST SpO2 Technology (Adults > 30kg, Pediatrics 10-50kg)
| Measurement | Accuracy Range | Reported Accuracy |
|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | ± 2% |
| Pulse Rate, No Motion | 25-240 bpm | ± 3 bpm |
The device meets its acceptance criteria as the reported accuracy values fall within the expected performance limits for similar oximetry sensors.
Study Details
The provided 510(k) summary (K100617) states that "The S2 Sensors comply with the voluntary standards as detailed in this submission" and lists "Performance Testing" as one of the quality assurance measures applied. However, the summary does not provide detailed information about the specific study(ies) (sample size, data provenance, ground truth establishment, etc.) used to derive these accuracy values.
Based on the provided text, the following information is not available:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify the number of subjects or types of data (e.g., patient data, simulated data) used for performance testing, nor does it mention the origin or retrospective/prospective nature of the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: There is no mention of any adjudication method.
- 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: This device is an oximeter sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Accuracy" values listed are inherently standalone performance metrics for the device itself.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not explicitly stated, for oximetry accuracy, ground truth is typically established through direct measurement of arterial blood gas (ABG) values (e.g., co-oximetry). The document does not confirm this.
- The sample size for the training set: As this is a medical device approval and not a machine learning model specific 510(k), the concept of a "training set" in the context of AI models is not directly applicable. Performance is evaluated against established physical and physiological principles.
- How the ground truth for the training set was established: Not applicable, as no training set in the AI sense is explicitly mentioned.
§ 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).