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Detection and analysis of vascular disease in peripheral vessels. Evaluation of degree and site of a stenosis. Detection of occlusions and flow disturbances. Determination of vessel type and location. Measurement of relative flow velocity. Not intended for fetal use.

Stenodoc is a mains independent portable continuous wave Doppler ultrasound device with two pen-shaped split-D transducers operating at 4 MHz and 8 MHz. A 512 point fast Fourier transform (FFT) is performed on the returned signal. The spectral distribution of blood flow is represented as a frequency over time diagram with intensities represented by different shades of gray. The diagram is displayed on a liquid crystal display (LCD). Measurements can be annotated with the patient's name, vessel name and a diagnosis and can be stored on a built-in harddisk for later evaluation. Size: 3" x 13.5" x 10" (Height/Width/Depth) Weight: 9 lbs.

Please note: The provided text is a 510(k) summary for a medical device (Stenodoc Bidirectional Vascular Doppler with Spectral Analysis) from 1995. Medical device regulation and the types of studies required for market clearance have evolved significantly since then. The information available in this summary is consistent with the regulatory landscape of its time, which did not typically include the detailed statistical performance metrics, extensive clinical trial data, or specific ground truth methodologies that are common in modern AI/ML device submissions.

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state "acceptance criteria" in the modern sense of quantifiable performance targets for a clinical study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device. The performance is assessed by comparing technical characteristics to the predicate.

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