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The Biospectrometer - NB 1111 is intended to noninvasively and continuously measure hemoglobin oxygen saturation:

• in the ear lobe with the 3mm probe
• in the arm, leg, or shoulder with the 15mm probe. The value of these measurements in disease states has not been demonstrated.

The Biospectrometer - NB Oximeter Model 1111 is a spectrophotometric monitoring system which measures an approximated value of percent hemoglobin oxygen saturation in tissue (S,O2). More specifically, the Biospectrometer - NB Oximeter measures the percent hemoglobin oxygen saturation of blood contained within the volume of tissue illuminated by the noninvasive probe. The S.O2 value is a function of the relative contribution of arterial, venous, and capillary blood.

The system consists of a patient probe (either 3mm or 15mm) containing optical fibers for transmitting light to tissue and receiving reflected light which is returned to a photo-sensitive detector. The nonsterile probe is designed to be placed on intact skin. The second system component is a monitor containing a spectrometer, light assembly, microprocessor, power supply, display monitor and kevboard. The third type of system component includes two (reference) canisters for use in calibration of the system. The Biospectrometer - NB Oximeter Model 1111 is AC operated.

The Biospectrometer - NB Oximeter Model 1111 measures an approximated value of the percent oxygen saturation of hemoglobin based on spectrophotometric measurement principles. Spectrophotometric measurements of hemoglobin have been well described by numerous authors. Today, spectrophotometric oximeters are commonly used clinically. By measuring absorbencies at suitable wavelengths, the ratio of oxygenated hemoglobin to total hemoglobin can be determined.

The depth of tissue measured by the Biospectrometer - NB Oximeter Model 1111 probe is determined by the probe design. The HTI Biospectrometer - NB 15mm probe measures to a maximum depth of 20mm. The 3mm probe measures to a maximum depth of 4mm.

The provided text K963903 for the "Biospectrometer - NB Oximeter Model 1111" does not contain specific acceptance criteria, a study proving device performance against such criteria, data provenance, expert ground truth details, adjudication methods, MRMC study results, or training set information.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor details about a study that proves the device meets specific criteria, as that information is not available in the provided text.

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