(15 days)
This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.
The Vista AVSTM is a diagnostic ultrasound device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi-directional Doppler for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Two additional modalities, Pulse Cuff Recording (PCR) and Photoplethysmography (PPG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, and the PPG will be used primarily to obtain toe pressures. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the device or uploaded using AVS ReportTM report generating software and an external user supplied PC via a USB port. The unit can run from an internal power source or from an external power supply, and mounts to a rolling stand.
The Summit Doppler Systems, Inc. Vista AVS is a diagnostic ultrasound device intended for the detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease. It measures systolic pressure values, provides bi-directional Doppler for blood flow, and controls pressure cuff inflation/deflation. It also incorporates Pulse Cuff Recording (PCR) and Photoplethysmography (PPG) and calculates Ankle Brachial Index (ABI) or Toe Brachial Index (TBI).
Here's an analysis of the provided information regarding its acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K063600) is a 510(k) premarket notification for substantial equivalence, not a detailed clinical study report with specific acceptance criteria and performance metrics for the device itself. The submission claims substantial equivalence to a predicate device (IMEXLAB 9100 Diagnostic Ultrasound Device, K973562).
Therefore, there are no explicit "acceptance criteria" or "reported device performance" metrics directly stated for the Vista AVS in this document in the typical sense of a clinical trial. Instead, the "acceptance criteria" can be inferred as demonstration of equivalence in:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as inferred from the document) |
|---|---|
| Intended Use Equivalence: Detect blood flow and aid in peripheral vascular disease diagnosis. | The Vista AVS is intended for "detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease." This exactly matches the intended use of its predicate device, as implied by the substantial equivalence claim. |
| Technological Equivalence: Utilize similar ultrasound technology. | The "Technologies Summary" states: "Doppler ultrasound technology is the same as substantially equivalent device shown above." This indicates the core technology, specifically Doppler ultrasound, is considered equivalent to the predicate. |
| Performance Equivalence: Provide comparable diagnostic information and functionality. | The "Description" section details the Vista AVS's capabilities: "obtain systolic pressure values at the arms, legs and feet," "provide a bi-directional Doppler," "control the inflation and deflation of a pressure cuff," include "Pulse Cuff Recording (PCR) and Photoplethysmography (PPG)," and "calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values." This implies that the device performs functions comparable to established vascular ultrasound monitors. |
| Safety and Effectiveness: Demonstrate safety and effectiveness comparable to the predicate. | The "Conclusion" states: "Based on comparisons of device features, materials, intended use and performance, and user instructions, the Vista AVS is shown to be substantially equivalent to the commercially available and legally marketed device indicated above." This is the primary claim of safety and effectiveness based on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a test set or clinical study specific to the Vista AVS for demonstrating performance against defined criteria. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to a legally marketed predicate device. There is no mention of patient data, sample sizes, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific test set or clinical study is described for the Vista AVS in this submission, there is no information about experts used to establish ground truth.
4. Adjudication Method for the Test Set
As there is no described test set, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device, not on directly comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Vista AVS is described as a diagnostic ultrasound device that aids clinicians. It is not an AI algorithm. Therefore, a standalone performance study in the context of an algorithm's performance without human-in-the-loop is not applicable here, and no such study is mentioned.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not applicable to this 510(k) submission. The submission is based on demonstrating substantial equivalence to a predicate device, meaning its "ground truth" for regulatory clearance is that it functions safely and effectively like the predicate device for its intended use.
8. The Sample Size for the Training Set
The Vista AVS is a physical medical device utilizing established Doppler ultrasound technology. It is not an AI system that requires a "training set" in the machine learning sense. Therefore, there is no information about a training set size.
9. How the Ground Truth for the Training Set Was Established
Since the Vista AVS is not an AI system developed with a machine learning training set, this question is not applicable.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.