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The BioArterial Plus Arterial Blood Flow Enhancement System is intended as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes:

Amputations (minor)
Angioplasty / stent failure
Arteriopathic wounds
Graft failure
Intermittent claudication
Ischemia
Night pain
Rest pain
Small vessel disease
Ulcers

Device Description

The BioArterial Plus Arterial Blood Flow Enhancement System is intended for the improvement of blood circulation in the lower extremities to help prevent and reduce complications of poor circulation, by increasing arterial blood flow through the application of bilateral or unilateral intermittent compression to the foot and calf.
The AC-powered device for consists of a pump, inflatable garments, and interconnection tubina. In operation, the device is attached via interconnect tubina to sleeves or garments containing discrete inflatable chambers applied externally and bilaterally over the feet and calves. Unique connector fittings on the interconnect tubing prevent accidental and incorrect pump/garment/anatomy combinations. Garments are available in a unique anatomical configuration, providing a single inflation chamber for the foot, and a single inflation chamber for the calf. Garments are supplied non-sterile, intended for single patient use, and are intended to be applied over bandages or clean hosiery. Hook-and-loop fasteners support a wide range of anatomy sizes. The device is intended for home use.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the "BioArterial Plus Arterial Blood Flow Enhancement System" based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
The product meets its specifications.	"Performance testing was performed and assures that the product meets its specifications."
Inflation cycle profiles (risetimes, cycle times, and inflation pressures) are similar to predicate devices.	"Bench testing was performed, comparing the inflation cycle profiles of the product to the predicate devices. The results of the testing demonstrate similar risetimes (time required to reach pressure), cycle times (total inflated and deflated times within a cycle), and inflation pressures."
The device is substantially equivalent to predicate devices, and does not raise any new questions of safety or effectiveness. (This is a regulatory acceptance criterion for 510(k) clearance).	"Based upon safety and performance testing, compliance with voluntary standards, and comparison to the predicate devices in terms of features, functionality, and bench comparisonal testing, the manufacturer believes that the BioArterial Pius Arterial Blood Flow Enhancement System is substantially equivalent to the predicate devices, and does not raise any new questions of safety or effectiveness." The FDA's 510(k) clearance letter (K072666) confirms this by stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Study Details from the Provided Document:

Sample size used for the test set and the data provenance:
The document does not specify a sample size or data provenance for human subject testing. The "Performance Data" section only mentions "bench testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the provided document details "bench testing" which is a comparison of product specifications against predicate devices, not observational human studies requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is an "Arterial Blood Flow Enhancement System" and not an AI-powered diagnostic or interpretive device that would involve human readers or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical medical device (pump and garments) for enhancing blood flow, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" used was the specifications and performance profiles of the predicate devices. The testing aimed to show similarity to these established devices rather than a biological or clinical ground truth in the traditional sense.
The sample size for the training set:
This information is not applicable as there is no mention of a "training set" for an algorithm or AI model within this 510(k) submission. The performance assessment was based on bench testing of the physical device.
How the ground truth for the training set was established:
This information is not applicable for the reasons stated above (no training set for an algorithm).

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