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The GE Vscan is indicated for ultrasound imaging, measurement and analysis of the human body in clinical applications of Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection; Its compact size, high degree of portability and simplified user interface enable it for adjunctive use for patient examination in primary care and in special care areas.

Device Description

The GE Vscan is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and fixed wired electronic-array transducer. It has an overall size approximately 73 mm wide, 135 mm deep and 28 mm high in transport configuration, and provides digital acquisition, processing and display capability. The user interface includes an intuitive layout of specialized controls and a color LCD display.

AI/ML Overview

The GE Vscan - Compact Diagnostic Ultrasound System (K092756) is a diagnostic ultrasound system.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated based on its substantial equivalence to predicate devices, rather than a quantifiable performance metric against a specific threshold. The "acceptance criteria" here are essentially meeting established safety standards and having comparable performance to existing, legally marketed ultrasound systems.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Non-clinical Tests	Conformance with applicable medical device safety standards for:	The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, and mechanical safety. It was found to conform with applicable medical device safety standards. The manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, and ISO 13485 quality systems. Compliance is verified through independent evaluation with ongoing factory surveillance.
Clinical Tests	Demonstration of safety and effectiveness through clinical trials.	"None required." The submission states that diagnostic ultrasound has a long history of safe and effective performance, and its intended uses and key features are consistent with traditional clinical practice and FDA guidelines.
Substantial Equivalence	Comparison to predicate devices (GE Vivid-e, GE Venue 40, Acuson P10) in type, safety, and effectiveness.	The GE Vscan is stated to be of a comparable type and substantially equivalent to the predicate devices. It is a compact and portable unit comparable in key safety and effectiveness features and utilizes the same patient contact materials as currently marketed transducers. It also has the same intended uses as the predicate devices.
Intended Use Alignment	Consistency of intended uses with predicate devices and traditional clinical practice.	The device has the same intended uses as the predicate devices, covering Fetal/OB; Abdominal; Pediatric; Urology; Cardiac (adult and pediatric), Peripheral Vessel and Thoracic/Pleural motion and fluid detection. Its compact size, portability, and simplified user interface enable adjunctive use in primary and special care.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: No specific test set sample size is mentioned for a performance study.
Data Provenance: Not applicable. The submission asserts substantial equivalence based on technical characteristics, established standards, and the known safety and effectiveness history of diagnostic ultrasound, rather than specific performance data from a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No ground truth establishment by experts for a specific test set is described. The basis for approval is substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Not applicable. There was no specific test set requiring adjudication.

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

No MRMC comparative effectiveness study was done. This is a compact diagnostic ultrasound system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a standalone diagnostic imaging device, but its "performance" is assessed through substantial equivalence and compliance with safety standards, not a standalone algorithm performance measurement.

7. The Type of Ground Truth Used

Not explicitly defined as "ground truth" in the context of a clinical study. The "ground truth" implicitly references:
- Established safety standards: Applicable medical device safety standards.
- Predicate device characteristics: The known performance and safety profiles of the GE Vivid-e, GE Venue 40, and Acuson P10 ultrasound systems.
- Historical evidence: The "long history of safe and effective performance" of diagnostic ultrasound in general.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device undergoing model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

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