Search Results

The LNOPv Ad-L and Pd-L Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) (measured by an SpO2 sensor) for use with Masimo SET pulse oximeters for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The LNOPv Ad L and Pd L Oximetry Sensors are fully compatible disposable sensors for use with Masimo SET pulse oximeter monitors. They represent a design change to the Masimo LNOPv Oximetry Sensors. The LNOPv Ad L and Pd L disposable sensors are similar in construction to the predicate devices LNOPv In and LNOPv Ne except that the LNOPv Ad L and Pd L have a shorter tail and the emitter and detector position is switched. The LNOPv Ad-Land Pd-L use the same emitters (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) as used in Masimo's LNOPv In and Ne sensors. The patient contacting materials in the LNOPv Ad-L and Pd-L disposable sensors are the same that is used in Masimo's LNOPv In and Ne sensors. The LNOPv Ad-L and Pd-L disposable sensors are supplied non sterile for single patient use. The LNOPv Ad L and Pd-L disposable sensors have the same electrical, optical, and material components as the LNOPv In and Ne disposable sensors.

The provided text describes the performance testing of the LNOPv Ad-L and Pd-L Oximetry Sensors. Here's a breakdown of the acceptance criteria and study details based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "healthy adult volunteer subjects" is stated, but an exact number is not provided.
• Data Provenance: The study was conducted on "healthy adult volunteer subjects" during "motion and no motion conditions." It is a prospective clinical study. Country of origin is not specified.

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

• The text does not mention the use of experts to establish ground truth in the traditional sense of image interpretation.
• Instead, the ground truth for SpO2 was determined by "measuring the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is a direct physiological measurement, not an expert interpretation.

4. Adjudication Method for the Test Set

• None applicable in the context of expert adjudication, as the ground truth was derived from direct physiological measurement (CO-Oximeter).

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the standalone performance of the oximetry sensors against a gold standard (CO-Oximeter) for SpO2 measurement, not on AI assistance for human readers.

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

• Yes, a standalone performance study was done for the device itself (the LNOPv Oximetry Sensors). The study evaluated the device's accuracy in measuring SpO2 without human interpretation or intervention in the measurement process.

7. The Type of Ground Truth Used

• The ground truth used was outcomes data from a CO-Oximeter, which directly measures arterial hemoglobin oxygen from arterial blood samples. This is considered a gold standard for blood oxygen saturation.

8. The Sample Size for the Training Set

• The text does not mention a separate training set or its sample size. This type of device (oximetry sensor) typically undergoes calibration during manufacturing and validation through clinical testing, rather than an explicit "training set" like an AI algorithm would.

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

• As no training set is explicitly mentioned or relevant in the context of this device's validation as described, this question is not applicable.

Ask a specific question about this device