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The TBL-ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). TBL-ABI is intended for rapid measurement of ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) in adults 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.

TBL-ABI can be used on patients with unilateral lower limb amputation.

The TBL-ABI System is intended to be used to spot-check patients. The TBL-ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information.

TBL-ABI System comprises:

• 3 Bluetooth blood pressure devices with attached cuffs.
• Software installed on a computer

It is intended to measure a patient's Ankle Brachial Index (ABI) and provide Pulse Volume Recording (PVR) / volume plethysmography.

This is done through an automated process.

The operator places the three devices with different color-coded electronic boxes on the right or left arm, and on each leg as described in the instructions for use, and the devices connect to the computer via Bluetooth.

Once the devices are connected, the operator clicks start on the software to start the measurement. The devices will then automatically control the inflation of the cuffs and monitor the 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.

TBL-ABI uses pneumo-plethysmography in order to obtain physiologic measurements from the patient's limbs.

Measurements are conducted as a single occurrence on the three limbs, thus eliminating any requirement to rest the patient between measurements.

The test period takes approximately 3 minutes.

ABI values, as well as the Pulse Volume recording (PVR), are displayed on the software installed in a computer. The results are saved in a backup file and can also be printed.

The TBL-ABI System, a device for measuring Ankle-Brachial Index (ABI) and Pulse Volume Recording (PVR), was reviewed for substantial equivalence to a legally marketed predicate device (TM-ABI, K143152). The provided document is a 510(k) summary, which typically presents a summary of verification and validation testing, rather than detailed study protocols and results for clinical performance. Therefore, information regarding human reader studies, ground truth establishment for clinical data, and specific sample sizes for clinical accuracy testing (if any were performed on human subjects) is not extensively detailed.

However, based on the provided text, the device primarily relies on non-clinical performance and engineering validation to demonstrate substantial equivalence, particularly concerning the accuracy of its physiological measurements and the safety of its technological changes (e.g., Bluetooth communication).

Here's an analysis of the acceptance criteria and the non-clinical study that proves the device meets these criteria, as described in the document:

1. Table of Acceptance Criteria (Performance Specifications) and Reported Device Performance (as claimed by the manufacturer and deemed sufficient by FDA):

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

• Sample Size: The document does not specify a "test set" in terms of human subjects or patient data for clinical performance evaluation. The study primarily relies on non-clinical testing (bench testing, engineering validation, software verification). The performance claims related to pressure accuracy and ABI accuracy (± 3mmHg and ± 0.1 respectively) are presented as specifications that are met, likely through calibration and validation against established standards or measurement principles rather than a patient-based test set.
• Data Provenance: Not applicable as the "study" described is verification and validation, predominantly on the device itself and its components. The document implies comparison to the predicate device's established performance, rather than new clinical data generation.

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

• Not applicable. As the evaluation focused on non-clinical performance and substantial equivalence to a predicate device with established performance specifications, "ground truth" was likely established through engineering standards, calibration references, and predicate device specifications. No mention of expert radiologists or similar clinical experts is found for establishing ground truth from patient data.

4. Adjudication Method for the Test Set:

• Not applicable, as the evaluation focused on non-clinical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study was not done. The device is a diagnostic tool that provides objective measurements (ABI, PVR) and does not involve human interpretation of images or signals that would typically necessitate an MRMC study to show human reader improvement with AI assistance.

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

• The device inherently operates as a "standalone" algorithm in that it performs automated measurements and calculations (Ankle-Brachial Index and Pulse Volume Recordings). The performance specifications for pressure and ABI accuracy (± 3mmHg, ± 0.1 ABI respectively) represent the algorithm's performance. The "study" (non-clinical testing) demonstrated that the device (including its algorithm for measurement calculation) meets these specified accuracy limits.

7. The Type of Ground Truth Used:

• For the core physiological measurements (pressure, ABI), the ground truth is implicitly based on metrological standards and established physiological measurement accuracy limits (e.g., ± 3mmHg for blood pressure, which is a widely accepted standard for non-invasive blood pressure devices). The device's performance is claimed to meet these standard accuracy limits, similar to its predicate device.
• For software and hardware functionality, the ground truth is derived from engineering specifications, test protocols (SRS/SDS/STD/STR), and standard compliance (e.g., IEC 60601 series).
• For biocompatibility, the ground truth is established by ISO 10993 standards.

8. The Sample Size for the Training Set:

• Not applicable. The document describes a 510(k) submission for substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a combination of non-clinical testing and comparison of technological characteristics. It does not typically involve training a machine learning model, which would require a training set. The device performs calculations based on established physical principles (pneumo-plethysmography), not learned patterns from data.

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

• Not applicable, as there was no training set for a machine learning model.

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