Search Results

Diagnostic ultrasound imaging of human soft tissues.

The DEI System acoustical holography imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Small organ imaging is intended for the breast.

Breast biopsy.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific acoustic output levels (track 1). Its function is to acquire ultrasound data in accustical holography mode and display it on an LCD monitor.

The DEI System is similar to the predicate device (OS-2000, K001510) in that both use an oblect transducer that is coupled to the patient by use of a water-path (immersion in water bath or use of water bladders) to transmit pulsed ultrasound through the targeted tissues. These transmitted pulses are then acoustically focused ultrasound beam is then combined with a second plane wave (reference wave) of the same frequency as the transmit wave. The interaction of the transmit wave and the reference wave creates an interference pattern on a target detector device within the enclosed system, forming an acoustic hologram of the object. The detector is illuminated with a coherent light source (laser) resulting in a visual image. The visual image is recorded with a CCD video camera and the images are displayed on a video monitor. Images may be stored to hard disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both allow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of focus (depth plane).

The provided text describes the Avera Model DEI System, an acoustical holography imaging system that includes a real-time image-guided biopsy capability. However, the text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices and outlining the intended uses and technical comparisons. It does not include details on the following:

1. A table of acceptance criteria and the reported device performance: This information is missing.
2. Sample size used for the test set and the data provenance: This information is missing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is missing.
4. Adjudication method for the test set: This information is missing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document describes an "Acoustical Holography Imaging System" and a "biopsy feature," but it does not mention any AI component or human-in-the-loop performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As there's no mention of an algorithm or AI, standalone performance is not discussed.
7. The type of ground truth used: This information is missing.
8. The sample size for the training set: This information is missing.
9. How the ground truth for the training set was established: This information is missing.

In summary, the provided text explains the regulatory clearance of the device and its technical description but does not offer any details regarding specific performance studies, acceptance criteria, or the methodology used to establish ground truth or assess performance.

Ask a specific question about this device