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The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg.

The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.

The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information.

The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.

The provided document is a 510(k) summary for the ClearMedical/Nellcor Oxisensor II O2 Transducer. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed study information required to fully answer the request. Specifically, it lacks comprehensive acceptance criteria with specific thresholds, detailed methodology of a study proving those criteria are met, and information about the training set.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not specified. The document mentions "clinical and/or non-clinical performance data" but does not give specific numbers for human subjects or test cases.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

   • Not specified. The document does not describe how ground truth was established, or if experts were involved in a capacity to establish ground truth for a test set.

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

   • Not specified.

4. 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 involving AI or human readers is not mentioned. The device is an O2 Transducer, not an AI diagnostic tool.

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

   • The device is a hardware sensor, not an algorithm. Standalone performance for a sensor would typically refer to its accuracy against a gold standard; however, details of such a test are not provided. The comparison is against another physical device (the predicate).

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

   • Not explicitly stated. The comparison is based on "comparative non-invasive Co-Oximetry and Oximetry data" against a predicate device. This suggests the predicate device's readings or an external reference oximetry method might have served as a de facto "ground truth" for comparison, but this is not clearly defined.

7. The sample size for the training set:

   • Not applicable as this is a hardware device, not an AI algorithm requiring a training set.

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

   • Not applicable.

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