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The Mobile CareGuide™ 2100 Oximeter is intended for use as an adjunct, non-invasive monitor of the hemoglobin oxygen saturation of microvascular blood in a region of skeletal muscle tissue beneath the sensor. The sensor may be positioned on pigmented skin. The Mobile CareGuide 2100 Oximeter is intended to allow for display of SmO2 data on a third party device, which would interface with the Mobile CareGuide 2100 Oximeter via USB or CAN connection. The Mobile CareGuide 2100 Oximeter is intended for prescriptive use (Rx only) by a trained healthcare professional in a hospital. The Mobile CareGuide 2100 Oximeter provides output of the most recent value of SmO2, as well as operational device information. The Mobile CareGuide 2100 Oximeter should not be used as the sole basis for diagnosis or therapy. Note: The prospective clinical value of data from the Mobile CareGuide 2100 Oximeter has not been demonstrated in disease states.

The Mobile CareGuide 2100 Oximeter sensor uses Near Infrared Spectroscopy (NIRS) to calculate muscle oxygen saturation (SmO2). The Mobile CareGuide 2100 Oximeter is a self-contained, medical oximeter. The sensor contains algorithms that calculate SmO2 from collected spectra and communicates the current SmO2 result to a 310 party display or patient monitor through a proprietary protocol. The Mobile CareGuide 2100 Oximeter reusable sensor contains the optical and electronic elements necessary to collect spectra from skin, fat and muscle. The sensor has a 3m long cord with either a USB connection or CAN connection to the 30 party display/patient monitor. The sensor contains 6 major components: (1) light sources to illuminate the skin; (2) a spectroscopic detector to analyze the reflected spectra back from the subject; (3) a microprocessor to control the optical components; (4) a microprocessor to perform the spectral analysis and generate the calculated SmO2; (5) one of two different communications components to transmit in CAN or USB format; (6) a battery to power all components. The Mobile CareGuide 2100 Oximeter Ray is a disposable sleeve which isolates the sensor optical elements from the patient's skin.

The provided text describes the Reflectance Medical, Inc. Mobile CareGuide™ 2100 Oximeter and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document states:

• "The accuracy and safety of the Mobile CareGuide 2100 Oximeter is the same as the predicate device."
• "Testing demonstrates that the Mobile CareGuide 2100 Oximeter is a safe and effective oximeter meeting all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the Mobile CareGuide 2100 Oximeter meets the expected performance requirements for an Oximeter..."

This indicates that performance testing was conducted, but the details of:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance results
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

are not present in the provided document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given information. The document focuses on demonstrating substantial equivalence to a predicate device based on identical technology, principle of operation, components, and intended use, rather than presenting a detailed performance study with acceptance criteria.

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