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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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The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI) and pulse volume recording (PVR)/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. ABPI MD system can be used on patients with unilateral lower limb amputation.

The ABPI MD system is intended to be used to spot-check patients. The ABPI MD system 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.

The ABPI MD system, is an automated ankle brachial pressure index measuring device, the system includes the following components:

• -ABPI measuring unit
• -Arm cuff size M
• -Left ankle cuff size M
• -Right ankle cuff size M
• -AC/DC power supply
• Tubes -
• -USB cable
• -Instructions for use, Installation and User guide, Certificate of Calibration, Certificate of Conformity and Warranty
• Software installed on a computer -

It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device. When connected, the operator clicks start button to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for the both left and right of the patient.

The provided text describes the MESI ABPI MD device, an automated ankle-brachial index measuring device, and its substantial equivalence to a predicate device, the TM-ABI System. However, the document does not contain an independent clinical study that directly proves the ABPI MD device meets specific acceptance criteria in terms of accuracy or performance metrics beyond those stated for the predicate device.

Instead, the submission relies on the assertion of identicality to the predicate device, TM-ABI, for which the original testing results are then applied. The core argument for the ABPI MD meeting acceptance criteria is that it is essentially the same device (manufactured by the same OEM) as the already cleared TM-ABI.

Here's the information extracted and organized based on your request, with the caveat that the "study that proves the device meets the acceptance criteria" refers to the predicate device's performance, as the ABPI MD itself did not undergo separate performance studies for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The same testing and validation performed to qualify the TM-ABI is the testing for the ABPI MD." Therefore, information regarding the specific sample size, country of origin, and retrospective/prospective nature of the data for these performance metrics would come from the original 510(k) submission for the TM-ABI System (K143152). This information is not provided in the current document (K172655).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

4. Adjudication Method for the Test Set

This information is not provided in the current document (K172655). It would be found in the original 510(k) submission for the predicate device (TM-ABI System).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

An MRMC study is typically for evaluating devices involving human interpretation of medical images or data. The ABPI MD (and its predicate) is an automated measuring device that produces numerical values (ABI, pressures). Therefore, an MRMC comparative effectiveness study in the traditional sense, comparing human readers with and without AI assistance, is not applicable to this type of device. The comparison is between the automated device and a gold standard measurement method (like a standard Doppler probe method, as indicated by the correlation coefficient).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the device (ABPI MD, and by extension, its predicate TM-ABI) is described as an "automated ankle brachial pressure index measuring device." This strongly implies that its performance metrics (like the ABI results and correlation with Doppler) are based on the standalone performance of the algorithm/device itself in comparison to a reference standard, without human-in-the-loop assistance influencing the measurement outcome.

7. The Type of Ground Truth Used

The ground truth for evaluating the accuracy of the ABI measurement is indicated by the "Coefficient of correlation r with the standard Doppler probe method." This suggests that the standard Doppler probe method was used as the reference or "ground truth" to which the automated device's measurements were compared.

8. The Sample Size for the Training Set

The document states that the ABPI MD is "identical to the predicate device" and that the "same test results apply to both devices" because MESI, d.o.o. is the OEM for both. This implies that the ABPI MD did not undergo a separate training process or study. Information regarding any training set used for the predicate device's development is not provided in the current document (K172655).

9. How the Ground Truth for the Training Set Was Established

Similar to point 8, this information is not provided in the current document (K172655). It would pertain to the development of the predicate device (TM-ABI System).

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