(70 days)
Vscan Extend is a general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage.
With the phased array transducer on the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics.
With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g., pleural motion/ sliding, line artifacts); and Pediatrics.
Vscan Extend is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a 5 inch touch screen display and a permanently attached probe. The probe is available in one of two configurations: a sector probe with phased array transducer or both phased and linear array transducers in the single probe (dual probe). It has digital acquisition, processing and display capabilities. The device specific battery can be charged either in the system or independently. The system also may include an AC/DC adapter with cable, case, Micro SD card, USB cable, or other accessories. The system is capable of transferring images wirelessly to a DICOM server or Windows share. Data can also be exported to the user's computer by using the USB export option and a standard USB/micro USB cable. Capabilities also include access to GE Marketplace, which shall allow the user to download software applications to the device.
The provided document is a 510(k) Premarket Notification Submission for the GE Vscan Extend Ultrasound System. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states:
"The subject of this premarket submission, Vscan Extend, did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because the document indicates that clinical studies were not required or performed for this submission to demonstrate substantial equivalence.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This would typically come from clinical study results, which are explicitly stated as not being required.
- Sample size used for the test set and the data provenance: No clinical test set details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- Sample size for the training set: No information on machine learning model training is provided, as the submission focuses on the ultrasound system itself, not necessarily an AI component requiring a training set in the context of clinical performance evaluation.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical safety and performance testing.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.