(60 days)
The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.
The Vantage ABI performs the ankle-brachial index examination to assist in the diagnosis of peripheral arterial disease. The system will be used to assess peripheral arterial disease using pneumatic volume plethysmography recording (PVR), estimate the systolic blood pressure for each limb and calculate the Ankle Brachial Index. The unit will record a PVR waveform at each ankle and measure pressures in each limb. Four cuffs will be connected. This unit can be powered from its internal battery or from an external line-powered supply.
This document is a 510(k) premarket notification for the Summit Doppler Systems, Inc. Vantage ABI device. It seeks to establish substantial equivalence to previously cleared predicate devices rather than conducting a new clinical study to prove novel efficacy or safety. Therefore, the information typically requested about acceptance criteria, study design, and performance metrics for a de novo device or a device requiring clinical trials is not present in this document.
Here's an analysis based on the provided text, highlighting what is not applicable in this context and what can be inferred:
1. Table of acceptance criteria and reported device performance:
- Not Applicable. This document focuses on establishing substantial equivalence to predicate devices, not on proving new performance against specific clinical acceptance criteria through a dedicated study. The "performance" mentioned is more about equivalence in function and intended use.
2. Sample size used for the test set and data provenance:
- Not Applicable. No specific test set data is provided in this 510(k) summary for a clinical study. The submission likely relied on engineering tests and comparisons to the predicate devices.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not Applicable. No clinical study involving a "test set" and "ground truth" established by experts for performance evaluation is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As no clinical "test set" for performance evaluation is detailed, no adjudication method is relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- Not Applicable. This device is a non-invasive instrument for measuring physiological parameters (PVR and ABI), not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC study and AI-assisted performance improvement are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The Vantage ABI is a hardware device that directly measures and calculates physiological parameters. It is not an algorithm-only software device. Its performance is inherent to its sensors and processing, designed to be used by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a 510(k) demonstrating substantial equivalence for a device like this, the "ground truth" effectively comes from the performance and established clinical utility of the predicate devices. The new device aims to perform in a similar manner to these already cleared devices.
8. The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
Summary of what can be inferred from the document regarding the device's "performance" and "acceptance":
The acceptance of the Vantage ABI device by the FDA is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the BioMedix, PADnet (K042616) and Summit Doppler Systems, Vista AVS (K063600).
The "study" in this context is the 510(k) premarket notification process itself, which involved:
- Comparison of device features, materials, intended use, and performance: The document explicitly states: "Based on comparisons of device features, materials, intended use and Conclusion: performance, and user instructions, the Vantage ABI is shown to be substantially equivalent to the commercially available and legally marketed device indicated above."
- Intended Use Equivalence: The Vantage ABI "is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease," which is the "same manner as the predicate devices."
- Technological Equivalence: The device "uses pneumatic volume plethysmography recording (PVR) and Ankle Brachial Index (ABI) to assist in the diagnosis of vascular disease in the same manner as the predicate devices."
Therefore, the "acceptance criteria" for this 510(k) were to demonstrate that the Vantage ABI is as safe and effective as its predicate devices, based on a direct comparison of its technical specifications and intended use, rather than conducting a de novo clinical trial with novel performance metrics. The FDA's issuance of the 510(k) clearance signifies that this criterion was met.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).