(366 days)
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
I apologize, but the provided text does not contain the specific details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or adjudication methods for the Delfin MoistureMeterD. The document is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study results that would typically contain such information.
To answer your request thoroughly, I would need a different document, such as a clinical study report, a scientific publication, or a more detailed section of the 510(k) submission that discusses the performance testing.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.