(20 days)
The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D Imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.
The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: (followed by tables listing specific applications and modes of operation for different transducers)
The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.
This document is a 510(k) summary for the Addition of 3D Imaging to the SONOLINE Elegra Diagnostic Ultrasound system. It outlines the device's description, intended uses, and technological comparison to a predicate device, but it does not contain details about a clinical study with acceptance criteria and device performance.
The tables provided in the document list various clinical applications for different transducers (e.g., SONOLINE Elegra, 2.0 CW probe, 2.5PL20 Phased Array Transducer, etc.) and indicate whether each application is a "new indication" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E) for certain imaging modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other). This information relates to the intended uses and regulatory clearance rather than a performance study.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's a breakdown of the specific points you requested and why they cannot be extracted from this document:
- A table of acceptance criteria and the reported device performance: This document does not contain any such table or details of a performance study with acceptance criteria. It primarily focuses on regulatory clearance and intended uses.
- Sample size used for the test set and the data provenance: Not available. The document does not describe a test set or its provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. Ground truth establishment for a test set is not discussed.
- Adjudication method for the test set: Not available. There is no mention of a test set or adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This document predates common AI applications in medical imaging and does not discuss such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. No details on algorithm performance are provided.
- The type of ground truth used: Not available. The document does not discuss ground truth for performance evaluation.
- The sample size for the training set: Not available. Training sets are not mentioned.
- How the ground truth for the training set was established: Not available. Ground truth for a training set is not discussed.
This 510(k) summary is a regulatory filing focused on demonstrating substantial equivalence to previously cleared devices for new features (3D imaging) and expanded use of existing transducers, rather than a clinical performance study report.
§ 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.