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The Reprocessed LNCS 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, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Reprocessed LNCS Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The Reprocessed LNCS Oximetry Sensors , are also compatible with Nellcor compatible pulse oximeter monitors.

The provided 510(k) summary describes the acceptance criteria and testing for Reprocessed LNCS Oximetry Sensors.

The central focus of the submission is to demonstrate substantial equivalence to existing predicate devices (Reprocessed LNCS Oximetry Sensors, 510(k) No. K083719), emphasizing that the new devices have the "same specifications."

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are the claimed accuracy ranges for SpO2 and pulse rate under various conditions, which are stated to be "the same specifications as the predicate devices." The device performance is implicitly stated to meet these criteria, as the conclusion is that the devices are "equivalent" and "met all design specifications."

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

The document indicates "performance testing including bench accuracy testing." However, the specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is not specified.

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

This information is not provided in the summary. The tests described are non-clinical (bench accuracy, biocompatibility, etc.), which typically do not involve human experts to establish ground truth in the same way clinical trials for diagnostic algorithms would. For oximetry devices, ground truth for SpO2 is usually established by a co-oximeter in controlled desaturation studies, which are not detailed here.

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

Not applicable. The testing described is non-clinical performance and bench testing, not a clinical study involving human reviewer adjudication of cases.

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

Not applicable. 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

Yes, "bench accuracy testing" falls under standalone testing, demonstrating the device's inherent performance. The results "demonstrated that the Reprocessed LNCS Oximetry Sensors are equivalent to the predicate devices" and "met all design specifications."

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

For "bench accuracy testing" of oximeter sensors, the ground truth for SpO2 measurements would typically be established using a co-oximeter in a controlled calibration or desaturation study setting. For pulse rate, a calibrated physiological simulator or ECG would typically be used. This specific detail is not explicitly stated but is the standard for such devices.

8. The sample size for the training set

Not applicable. This device is a reprocessed sensor, and the testing described is verification against specifications and predicate device equivalence, not the training of an algorithm.

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

Not applicable. There is no algorithm training set discussed for this device.

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