(238 days)
The PADnet Xpress is a non-invasive device used to assess the lower and upper extremity arterial circulatory systems in order to assist in the identification of vascular disease in adults. To assess the arterial system, PADnet Xpress uses pulse volume recording. It is intended to be used by healthcare professionals in either a professional medical or home environment. The device is not intended for pediatric or fetal use. It is also not intended for the use on or near non-intact skin.
PADnet Xpress, like the PADnet 2.0 aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial/Dorsalis Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Artery Disease (PAD). Following each test PADnet Xpress provides documented results, including waveforms, as part of the final report, which may be viewed on the system display, in printed form, and/or digitaly saved. PADnet Xpress was designed, in response to consumer feedback, to perform a subset of tests, namely PAD screening, which the predicate PADnet 2.0 device is capable of in a smaller, more portable form factor. The design modifications did not alter the intended use and are modest departures from the existing, previously cleared technological characteristics of the PADnet 2.0. While the intended use is not altered, there are minor modifications for use to remove elements of the indication not associated with arterial pulse contour analysis, and segmental systolic blood pressure measurements, as well as to allow for home use by a trained operator.
When performing an assessment, the clinician places a sensor and takes a measurement on each lower extremity. The sensor detects changes in arterial blood volume. This signal is digitized and sent to a computer via a wired connection, where it runs a proprietary software application calculates the result, which is based on the features of the volume plethysmographic signals from the Brachial, Anterior Tibial arterial distributions. The indications for use are almost identical to the PADnet 2.0, the predicate device, but PADnet Xpress has also been tested for compliance with IEC 60601-1-11 home use electrical safety standards and is indicated for use in that environment as well with no change to the safety or effectiveness of the device. The PADnet Xpress sensor used with the predicate, is made from Makrolon plastic.
This document is a 510(k) summary for the PADnet Xpress device. It outlines the device's indications for use, comparison to a predicate device (PADnet 2.0), and provides a summary of non-clinical and/or clinical tests. However, the document explicitly states that no additional performance testing was needed to demonstrate substantial equivalence for the PADnet Xpress because the underlying technology is unchanged from the predicate device.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document as a study proving the device meets acceptance criteria was not conducted for the PADnet Xpress due to the nature of this 510(k) submission.
The document indicates:
- Non-Clinical and/or Clinical Tests Summary & Conclusions: "Since the underlying technology for aiding in the disease is unchanged between the predicate PADnet 2.0 device and the modified PADnet Xpress, a risk analysis determined that additional performance testing was not needed to demonstrate the substantive equivalence of the safety and effectiveness of the device."
This means that the information you are requesting about a study proving the device meets acceptance criteria, including details about sample sizes, experts, ground truth, etc., is not present because such a study was deemed unnecessary for this 510(k) submission. The FDA cleared the device based on its substantial equivalence to a previously cleared predicate device whose performance data would have been evaluated during its initial clearance.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).