(261 days)
The TM-ABI system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD).
TM-ABI system is intended for the rapid measurement of ankle-brachial pressure index (ABP), or ankle-brachial index (ABI), and pulse volume recording (PVR) / volume plethysmography in adults. It is suitable for use in wound care assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to the application of compression therapy.
TM-ABI system can be used on patients with unilateral lower limb amputation.
The TM-ABI System is intended to be used to spot-check patients. The TM-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.
TM-ABI System is a programmable electro medical system (PEMS). The system comprises:
- Σ USB plug and play hardware.
- 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 on the software 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 both the left and right of the patient.
TM-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from patient's limbs. Measurements are conducted as a single occurrence on the three liminating any requirement to rest the patient between measurements. The test period takes approximately 3 minutes. The ABPI or ABI are calculated using the conventional algorithm: The device measures systolic pressures on arm and 2 ankles and then calculates the ABIs as follows:
Left ABI = Left ankle pressure / Arm pressure
Right ABI = Right ankle pressure / Arm pressure
ABPI values, as well as the Pulse Volume recording (PVR), are displayed on the LCD, and on a software installed in a computer. The results are saved in a backup and can also be printed.
Here's an analysis of the acceptance criteria and study information for the TM-ABI System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal / Predicate Performance) | Reported Device Performance (TM-ABI System) |
|---|---|
| Intended Use: Rapid measurement of ABI/ABPI and PVR for PAD risk assessment, wound care, screening, and before compression therapy. | Intended Use: Same as acceptance criteria. |
| Measurement Accuracy (ABI/ABPI): Ankle brachial pressure index: ± 0.1 | Measurement Accuracy (ABI/ABPI): Ankle brachial pressure index: ± 0.1 |
| Correlation with Standard Doppler Probe Method: r=0.89 (Predicate device) | Correlation with Standard Doppler Probe Method: r=0.88 |
| Patient Population: Adult | Patient Population: Adult |
| Use Environment: Clinical environment | Use Environment: Clinical environment |
| Software Performance: Accurately capture, store, and analyze data. | Confirmed via CRC Coding and Software verification (SRS/SDS/STD/STR). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "Clinical Study comparing the device results and standard Doppler method results to assess the Ankle Brachial Index." However, it does not explicitly state the sample size for this clinical study.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be a prospective study comparing the device to the standard Doppler method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications for establishing the ground truth. It refers to "the standard Doppler probe method" as the comparative reference.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. The clinical study is described as comparing the device results directly to the standard Doppler method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically mentioned or described in the provided text. The study focused on the device's performance against a reference method (Doppler probe) rather than measuring improvements in human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The clinical study evaluated the device's ability to measure ABI/ABPI against the standard Doppler probe method. The device automates the process of inflation, pressure monitoring, and ABI calculation. The reported "r=0.88" is a measure of the algorithm's performance in correlation with the reference.
7. Type of Ground Truth Used
The ground truth used for the clinical study was the standard Doppler probe method for measuring Ankle Brachial Index (ABI). This is a well-established clinical gold standard for ABI measurement.
8. Sample Size for the Training Set
The document does not explicitly state the sample size for any training set. The device utilizes an "oscillometric method" and pre-defined algorithms for calculating ABI. While such systems are developed using data, the 510(k) summary focuses on the validation of the final device, not the specifics of its internal model training.
9. How the Ground Truth for the Training Set Was Established
Since a training set sample size or a distinct "training set" study is not detailed, the method for establishing its ground truth is also not described. The device's underlying technology (oscillometry) and algorithms are likely based on established physiological principles and prior data, but the specifics of a training data ground truth are not provided in this document.
§ 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).