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The PADChek™ ABI/PVR is a non-invasive device used to assist in the detection of peripheral artery disease (PAD). Pressure measurements at the ankles (dorsalis pedis and/or posterior tibialis arteries) are compared to the highest pressure in either arm (brachial arteries) and a ABI (Ankle Brachial Index) is calculated. A Pulse Volume Recording (PVR) is simultaneously performed to determine the presence of blood flow. It is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.

PADCHEK ABI/PVR performs an Ankle Brachial Index (ABI) test by measuring systolic BP at the brachial artery in each arm and systolic BP at the dorsalis pedis and/or posterior arteries The ABI is expressed as the ratio of ankle systolic pressure divided by the at the ankles. highest brachial systolic pressure. A result is obtained for each leg. A pulse wave pattern and pulse volume recording is recorded for each limb measurement. A sitting BP, pulse, pulse pressure at the brachial artery is also obtained. Results are stored in a database and can be printed at the time of point-of-care testing or later.

The provided text describes the PADCHEK ABI/PVR device, its intended use, and general compliance with standards, but does not contain the specific details about acceptance criteria, the study proving it meets those criteria, or the performance data requested in your prompt.

The document states "See attached data" under "Device Performance" but this attachment is not provided in the input text. Therefore, I cannot extract the specific information you are looking for regarding the device's performance against acceptance criteria, study details, ground truth, or expert involvement.

Based on the provided text, I can only provide the following information:

• 1. A table of acceptance criteria and the reported device performance: This information is "See attached data" in the original document, which is not provided.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in the provided text.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available in the provided text.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in the provided text.
• 5. 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: Not available in the provided text. This device is not described as an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not described as an algorithm-only device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text.
• 8. The sample size for the training set: Not applicable, as this device is not described as an AI/ML product requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable, as this device is not described as an AI/ML product requiring a training set.

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