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The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.

The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board. The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters. The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not explicitly stated as a numerical value for the test set. The text mentions "healthy adult volunteer subjects" and separately "neonatal sensors were validated on adult volunteers." It doesn't specify the number of subjects used in either case.
• Data Provenance: The studies used human subjects, but the country of origin is not specified. The study is prospective, as it involved "progressive induced hypoxia" in volunteers.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not mentioned. The ground truth was established using a CO-Oximeter, not human expert consensus for interpreting medical images or signals.
• Qualifications of Experts: N/A.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The ground truth was determined by a CO-Oximeter, which is an objective measurement tool, not subject to human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC study was not performed. This device is an adapter cable for a pulse oximeter, and the performance testing focuses on the accuracy of its physiological measurement against a reference standard, not on human reader interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed in the sense that the device's measurement (SpO2) was compared directly against an objective ground truth (CO-Oximeter). There isn't an "algorithm" in the typical sense of AI/image analysis, but the device's output itself was evaluated.

7. Type of Ground Truth Used

• Ground Truth: Arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter. This is an objective, laboratory-based measurement.

8. Sample Size for Training Set

• Not applicable/not mentioned. Pulse oximeters (and their cables) are generally based on physical principles of light absorption and are typically calibrated and validated through engineering tests and clinical studies (as described here) rather than trained on large datasets like machine learning models. The text describes performance testing, not a training phase.

9. How Ground Truth for Training Set Was Established

• Not applicable. As noted above, this device's performance is not based on a "training set" in the context of machine learning. The clinical validation described establishes its accuracy against a known truth.

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