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The LNCS Sensors and Cables are indicated for the continuous nonitoring of functional oxygen saturation I he LNCS Sellsons and Cables are multided for and continued by an SpO2 sensor) for use with adult, pediatric, infant, and of arterial nemogroum (op(0)) and pare (motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

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

The LNCS DC-I/DC-IP reusable sensors are essentially identical to Masimo LNOP-DC-I/DC-IP sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the LNCS DC-I/DC-IP and LNOP-DC-I/DC-IP sensors. The patient contacting materials in the LNCS DC-I/DC-IP and LNOP-DC-IP sensors are the same. The LNCS DC-I/DC-IP sensors are supplied non-sterile.

The LNCS TC-I and TF-I reusable sensors are essentially identical to Masimo LNOP-Ear and TF-I sensors except for the connector at the end of the cable which interfaces with the LNCS patient cable. The same emitter (with Red wavelength of 653/659 nm and Infrared wavelength of 880 nm respectively) and detector are used in both the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors. The patient contacting materials in the LNCS TC-I and TF-I and LNOP- Ear and TF-I sensors are the same. The LNCS TC-I and TF-I sensors are supplied non-sterile.

The LNCS disposable sensors are similar in construction to the predicate devices except that the LNCS sensors are cable based while the LNOP sensors are flex circuit based. The emitter and detector are connected to the cable assembly. 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 Masimo's LNOP series of disposable sensors. Four sizes of disposable LNCS sensors are available for use with adult, pediatric, infant and neonatal 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 LNCS disposable sensors are the same that is used in Masimo's LNOP sensor line. The LNCS disposable sensors are supplied non-sterile for single patient use.

The LNCS patient cables are similar in construction to the predicate device enabling the LNCS Oximetry Sensors to be connected to Masimo and Masimo compatible pulse oximeter monitors.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary indicates that the accuracy of the LNCS oximetry sensors is equivalent to the predicate devices. The summary explicitly states:

Note: The document states that the "LNCS oximetry sensors are substantially equivalent...and performance to predicate sensors" and that "The accuracy of the LNCS oximetry sensors is equivalent to those of the predicate devices." The specific accuracy values presented in the "Clinical Testing" section are attributed to "SPO2.COM Disposable and Reusable sensors." While these are listed as predicate devices in the 510(k) (K033298), the document implies that the LNCS sensors achieve equivalent performance to these predicate devices, thus meeting these implied acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "healthy adult volunteer subjects" and "adults, pediatrics and infants and neonates" were included. However, the exact number of subjects or data points is not provided.
• Data Provenance: The study was conducted on "healthy adult volunteer subjects" and involved "induced hypoxia." This indicates a prospective clinical study. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable in this context. The ground truth for SpO2 measurements is not established by human experts in the typical sense of image or diagnostic interpretation.
• Qualifications of Experts: Not applicable. The ground truth relied on a CO-Oximeter to measure arterial hemoglobin oxygen from arterial blood samples.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement from a CO-Oximeter, not through human interpretation requiring adjudication.

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 oximeter sensor, not an AI-powered diagnostic tool that assists human readers.

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

• Standalone Performance: Yes, the clinical testing describes the standalone performance of the oximetry sensors against a reference standard (CO-Oximeter). The device itself is the 'algorithm' in this context, directly measuring and reporting SpO2.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, gold-standard measurement for blood oxygen saturation.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a medical device (sensor) and its performance, not a machine learning model that would typically have a distinct training set. The device's design and parameters are established through engineering and previous device iterations rather than a "training set" in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device where a training set with established ground truth would be relevant in the same way. The device's operating principles are based on established physiological and photometric principles.

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