(511 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device Value) | Reported Device Performance (STENODOC™ Value) |
|---|---|---|
| Device Type | Bidirectional Doppler | Bidirectional Doppler |
| Ultrasound mode | continuous wave | continuous wave |
| Transducers | 4 and 8MHz split D | 4 and 8MHz split D |
| ISPTA 8 MHz Probe | 90 mW/cm2 |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.