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The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).

MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (AB) and pulse volume plethysmography in adults.

It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy.

MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients.

The MESI mTABLET ABI provides information regarding patient risk.

The physician has the responsibility of making proper judgments based on this information.

Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

MESI mTABLET ABI is a medical device comprised out of three parts. Diagnostic modules with a tubeless cuff (ABISYS) that is attached to a patient upper arms and ankles, a medical grade tablet used to display the measurement (MTABSYSW) and a charging station (CS4SYS). It is used in a professional clinical environment by trained medical experts for diaqnostic and screening purposes.

MESI mTABLET ABI is a device used for screening of Peripheral Arterial Disease (PAD). The measurement is performed non-invasively by measuring blood pressure in the brachial artery and pressures in the foot arteries (dorsalis pedis and the posterior tibial artery). After the blood pressures have been measured the MESI mTABLET ABI calculates the ration between higher of the two arm values and both ankles.

The provided text is a 510(k) summary for the MESI mTABLET ABI, an automated ankle-brachial pressure index measuring device. This document focuses on demonstrating substantial equivalence to a predicate device (ABPI MD) and includes information about the device's design, intended use, and general testing compliance, rather than detailed performance study results that would typically include specific acceptance criteria and their outcome.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document. The document states that the new device has "same performances and effectiveness" as the predicate device and that the "ABI results: Coefficient of correlation r with the standard Doppler probe method" for both the predicate and the new device is "r= 0.88". This is the closest the document comes to a performance metric, but it is presented as a characteristic shared with the predicate rather than an acceptance criterion for the new device's performance study.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: These are presented as characteristics shared with the predicate device, implying they are met by the new device. The document does not detail specific performance study acceptance criteria for the MESI mTABLET ABI itself beyond asserting "same performances and effectiveness" as the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text for any performance studies.
• Data Provenance: Not specified. The document describes a comparison to a predicate device and general testing (biocompatibility, software, electrical, EMC, usability), but not a specific clinical test set for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The document states the device provides "information regarding patient risk" and "The physician has the responsibility of making proper judgments based on this information." This implies human expert involvement in diagnosis and judgment, but not their role in establishing ground truth for a test set for the device's performance validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not specified.

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 specified. The device is for automated measurement of ABI and plethysmography, not an AI-assisted diagnostic imaging tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The device is described as an "Automated ankle-brachial pressure index measuring device." This inherently suggests standalone algorithm performance for the measurement aspect. However, no specific standalone performance study details (metrics, results, methodology) are provided beyond the stated correlation and error limits.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The document mentions "Coefficient of correlation r with the standard Doppler probe method." This strongly suggests the Doppler probe method is considered the "ground truth" or reference standard against which the device's measurements are compared.

8. The sample size for the training set:

• Not specified. This document is a 510(k) summary for a measurement device, not an AI/Machine Learning model that would typically have a "training set."

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI/ML device in the context of a training set. If considering "ground truth" for the device's development and calibration, it would likely be established through comparison to established, accurate methods like the Doppler probe.

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