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The Visor System is a bioimpedance spectroscopy device indicated to measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment.

The Visor System is an adjunct to standard methodologies for clinical evaluation.

The Visor System is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Cerebrotech Visor System, detailing its substantial equivalence to a predicate device (CMS-5000) based on modifications to its physical dimensions, user interface software platform, and power source.

The document discusses:

• Indications for Use: To measure impedance ratios to aid in the assessment of cerebral fluid volume asymmetry between the cerebral hemispheres in adult patients undergoing neurologic assessment, as an adjunct to standard methodologies.
• Technological Characteristics: Multi-frequency Bioimpedance Spectroscopy using low-power radio frequency current.
• Comparison to Predicate: The Visor System is essentially the CMS-5000 with a smaller profile due to a change from a MacBook laptop to an Android tablet for the user interface, and a removable rechargeable battery.

It explicitly states, "The Visor System is the same device as the predicate with some modifications. It provides adjunct information about tissue fluid differences derived from bioimpedance ratios and does not replace standard diagnostic techniques, which may include physical examination, medical imaging, and professional judgment. The systems are therefore substantially equivalent."

This means the submission focuses on demonstrating that the modified device (Visor System) is as safe and effective as the previously cleared predicate device (CMS-5000), rather than providing new performance criteria and a study to meet those criteria. The verification of the CerebroScan software in the Android Tablet is mentioned as being provided in the 510(k) submission, but the details of this verification, including specific acceptance criteria, sample size, or study design, are not included in this summary.

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The CMS-5000 is a bioimpedance spectroscopy device for use on adult human patients utilizing impedance ratios that are displayed as a B-DEX ratio as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The CMS-5000 is an adjunct to standard methodologies routinely used in the clinical evaluation of intracranial fluid distribution and is not intended to be a sole determinant.

The CMS-5000 is a bioimpedance spectroscopy device used to monitor patients who have conditions that predispose them to fluid volume changes. The device uses Volumetric Integral Phase-Shift Spectroscopy (VIPS) technology. Changes in the volume of fluids in the human skull can be detected by monitoring changes in electrical properties. VIPS technology measures the frequency response of the phase angle shift between an emitter antenna and a detector antenna, when placed on opposite sides of the head. The device is intended to be used as an aid to clinical assessment in conjunction with current standards of care.

The provided text is a 510(k) summary for the Cerebrotech CMS-5000 device. It states that no clinical testing was required due to the device's substantial equivalence to predicate devices, and therefore, it does not contain the detailed information about acceptance criteria and the study that proves the device meets those criteria, as requested in the prompt. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Impedimed L-Dex U400) through comparison of technological characteristics and non-clinical performance (bench tests, human head phantoms, mathematical models).

Therefore, I cannot provide the requested information from the given text.

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