(84 days)
Vscan Extend is a general purpose diagnostic ultrasound 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, thoracentesis, 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.
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
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 for the GE Vscan Extend ultrasound system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance efficacy studies with acceptance criteria for an AI/algorithm-driven device in the manner requested.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies, are not available in this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, or specificity. Instead, it demonstrates "substantial equivalence" based on technological characteristics and safety. The reported performance relates to the device's functional capabilities and compliance with safety standards, rather than clinical efficacy metrics against specific acceptance thresholds.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states: "The subject of this premarket submission, Vscan Extend, did not require clinical studies to support substantial equivalence." Therefore, there is no test set in the context of clinical performance evaluation described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies were required or performed for this premarket submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were required or performed for this premarket submission.
5. 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 applicable. This is a submission for an ultrasound imaging system, not an AI-assisted diagnostic device. The document explicitly states "did not require clinical studies."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/algorithm-only device. It is a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were required or performed for this premarket submission.
8. The sample size for the training set
Not applicable, as no AI model training is described for this device in the context of this submission.
9. How the ground truth for the training set was established
Not applicable, as no AI model training is described.
Summary of Non-Clinical Tests and Standards Met (from the document):
The device underwent non-clinical tests to ensure safety and functionality. These include:
- Acoustic Output: Evaluated for compliance.
- Biocompatibility: Evaluated, transducer materials are biocompatible.
- Cleaning and Disinfection: Evaluated.
- Thermal, Electrical, Electromagnetic, and Mechanical Safety: Evaluated.
The device conforms to the following voluntary standards:
- AAMI/ANSI ES60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance, 2005
- IEC60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
- IEC60601-2-37: Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- NEMA UD 3: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
- ISO10993-1: Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009
- NEMA UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, 2004
- ISO14971: Application of risk management to medical devices: Second edition, 2007
- NEMA PS 3.1-3.20 (2011): Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
Quality assurance measures applied during development:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Verification of Privacy & Security Design
Conclusion of the device's substantial equivalence:
GE Healthcare considers the Vscan Extend to be as safe, as effective, and performance is substantially equivalent to the predicate device(s) based on intended use, imaging capabilities, technological characteristics, and safety and effectiveness. The document highlights that the Vscan Extend employs the same fundamental scientific technology as its predicate devices, shares the same clinical intended use (with the addition of adult cephalic cleared on a predicate), imaging modes, materials, acoustic power levels (below FDA limits), and capabilities for measurements, digital image capture, and review. It also specifies similar connectivity features (WiFi, DICOM) and data privacy features (internal storage encryption) to reference predicate devices.
§ 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.