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The LNOP x Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infam, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The LNOP x and LNOP X Oximely Sellsols are indicated for the ventinated by an SpO2 sensor) for use with ault, oxygen saturation of areflal nemogroum (3002) and motion and for patients who are well or pediative, intaint, and neonally darking overling over, and home environments. poorly perfused in hospital-type facilities, mobile, and home environments.

The LNOPx and LNOP x Oximetry Sensors are fully compatible disposable and reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.

The LNOP x and LNOP x disposable sensors are similar in construction to the predicate devices except that the SPO2 COM sensors are cable based while the LNOP sensors including the LNOP x sensors are flex circuit based. The emitter and detector are connected to the flex circuit. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masmo's LNOP series of disposable sensors. Two sizes of disposable LNOPy sensors are available for use with infant and neonatal patients. Two sizes of disposable LNOP x sensors are available for use with adult and pediatric patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the bandage material The patient contacting materials in the LNOP x disposable sensors are the same that is used in Masimo's SPO2.COM sensor line. The LNOP x disposable sensors are supplied non-sterile for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance

Note: The document only explicitly states accuracy for SpO2. While biocompatibility and environmental testing were performed and passed, specific quantitative acceptance criteria for these were not provided in the summary. The "less than 2% Apys" and "less than 3% Apys" values likely represent the accuracy specifications (e.g., RMS error or similar statistical measure) used by the manufacturer as acceptance criteria for their devices.

Study Information:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" but does not quantify how many unique subjects were included in the clinical studies. It also states the studies were done for "adults, pediatrics and infants and for neonates," implying different cohorts, but again, no numbers are given.
• Data Provenance: The study was conducted clinically with human subjects. The country of origin is not specified but generally, such studies are conducted within the country of the submitting company or in regions with comparable regulatory standards. It was a prospective study, as subjects were "subjected to a progressive induced hypoxia."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth method involved a "CO-Oximeter," which is an instrument, not human experts. Human oversight of the CO-Oximeter operation would be assumed, but their qualifications are not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. The ground truth was established by an objective instrument (CO-Oximeter) measuring arterial blood samples, not by human expert consensus or adjudication of subjective data.

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:

• MRMC Study: No, an MRMC study was not done. This device is an oximetry sensor, which is a measurement device, not an AI diagnostic tool that assists human readers in interpreting images or other data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, the clinical testing describes the "accuracy of the LNOP x Oximetry Sensors" against direct arterial blood gas measurements, which is a standalone performance assessment of the sensor's accuracy in measuring SpO2. The device functions independently to provide a physiological measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: Objective measurement from a CO-Oximeter analysis of arterial blood samples. This is considered a highly accurate, direct physiological measurement.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This document describes a medical device (sensor) that performs physical measurements, not an AI/ML algorithm that requires a training set. The "design change" refers to hardware and material changes, not algorithmic learning.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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