(128 days)
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
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (ABPI MD claims identicality to Predicate) |
|---|---|
| Ankle brachial pressure index: ± 0.1 | Ankle brachial pressure index: ± 0.1 |
| Diastolic pressure range: 40 to 180 mmHg | Diastolic pressure range: 40 to 180 mmHg |
| Systolic pressure range: 39 to 242 mmHg | Systolic pressure range: 39 to 242 mmHg |
| ABI results: Coefficient of correlation (r) with the standard Doppler probe method = 0.88 | ABI results: Coefficient of correlation (r) with the standard Doppler probe method = 0.88 |
| Electrical safety (IEC 60601-1, 60601-1-2, 80601-2-30) | Compliant with standards: 60601-1, 60601-1-2, 80601-2-30 |
| Biocompatibility (ISO 10993-1) | Biocompatibility testing performed in accordance to ISO 10993-1 |
| Software verification and validation | Software verification and validation testing conducted and documentation provided |
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).
§ 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).