Search Results

Diagnostic ultrasound imaging or fluid flow measurement of the human body as follows: Fetal, Abdominal, Intra-operative (Abdominal organs and vascular), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
Additional Comments: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging for guidance of biopsy previously cleared through 510(k) K014116. Included with this 510k are imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

The SonoSite Hand-Carried Ultrasound System (PowerSeries) is a highly portable, software controlled ultrasound system used to acquire and display high-resolution, real-time ultrasound data in 2D and other modes as Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and PowerMap™ Directional Color Power Doppler, or a combination of these modes with 2D. These modes of operation are dependent on the type of transducer that is attached to the system, with the exception of 2D. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System may include PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, non-diagnostic ECG capability for the collection of data for M-mode measurements, measurements and calculations, image storage and review, printing, and recording capabilities. Additionally, the system provides ultrasound guidance to assist in the placement of needles and catheters in vascular or other anatomical structures. The SonoSite Hand-Carried Ultrasound System (PowerSeries) may have curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel. The transducer is not detachable from the System.

The provided text is a 510(k) Summary of Safety and Effectiveness for the SonoSite Hand-Carried Ultrasound System (PowerSeries). It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

Instead, the document focuses on:

• Device Description: What the ultrasound system does, its modes of operation (2D, PW Doppler, CW Doppler, Color Power Doppler, PowerMap™ Directional Color Power Doppler), and its measurement capabilities.
• Intended Use: A list of clinical applications for which the device is intended (e.g., Fetal - OB/GYN, Abdominal, Cardiac, Peripheral Vessel), and which transducers support those applications.
• Technological Characteristics: How the device operates and its compliance with various standards related to safety and acoustic output (e.g., EN 60601-1, AIUM standards).
• Substantial Equivalence: A comparison to previously cleared predicate devices (K014116, K010374, K961459, K993624).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document. The document confirms that the device complies with safety standards and states its acoustic output limits, but these are not presented as "acceptance criteria" for performance that a study then demonstrates.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not present. The document lists acoustic output limits that the device "conforms to" but doesn't provide specific performance metrics it needs to meet or a study showing it does.
2. Sample size used for the test set and the data provenance: No performance study is detailed, so no test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
4. Adjudication method for the test set: Not applicable as no performance study is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. The document describes a diagnostic ultrasound system, not an AI or AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic ultrasound system, not an algorithm being submitted.
7. The type of ground truth used: Not applicable as no performance study is described.
8. The sample size for the training set: Not applicable as no algorithm training is discussed.
9. How the ground truth for the training set was established: Not applicable as no algorithm training is discussed.

Ask a specific question about this device