(167 days)
The Venue Fit is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices, for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. Venue Fit is intended to be used in a hospital or medical clinic. Venue Fit clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD. B/Color/CWD.
The Venue Fit is a general purpose diagnostic ultrasound system. It is a portable system with a touch screen interface. It can be powered through an electrical wall outlet or an internal battery. It utilizes linear, convex, and phased array transducers and supports standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures. The system can display the patient's ECG trace synchronized to the scanned image. A barcode reader and RFID scanner are available as additional input devices. A roller bag is available for transport. It is capable of wired or wireless internet connection and meets DICOM requirements for image storage and archiving.
The provided text describes specific features and functionalities of the GE Venue Fit ultrasound system but does not contain information about acceptance criteria, reported device performance, or a specific study proving it meets acceptance criteria as typically outlined for AI/CADe devices.
The document is a 510(k) Premarket Notification Submission for the Venue Fit ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (K220848 Venue Fit) regarding general imaging capabilities, technological characteristics, safety, and effectiveness.
Here's what can be extracted and what is explicitly stated as not applicable:
1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document focuses on performance testing in the context of safety and effectiveness, rather than specific diagnostic accuracy metrics.
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, Venue Fit, did not require clinical studies to support substantial equivalence." Therefore, there is no test set in the context of a clinical study for diagnostic performance.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were required.
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 document does not describe an AI/CADe device that assists human readers, nor does it present results from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Venue Fit is a diagnostic ultrasound system, not a standalone algorithm. Its capabilities, like "Auto Volume Flow (AVF)" or "Bladder Volume Tool", are functionalities of the ultrasound system itself, not standalone AI algorithms with reported diagnostic performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies requiring ground truth establishment were mentioned.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning algorithm that would have a training set. The "Venue Fit" is a general-purpose diagnostic ultrasound system. While it has "semi-automated tools," the document does not detail their development or any AI-specific training sets.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI algorithm.
Summary of what is present:
The document establishes substantial equivalence through a comparison to a predicate device (K220848 Venue Fit) and a list of reference devices (K231301 Vscan Air, K161047 LOGIQ P9 and LOGIQ P7, K231989 LOGIQ E10s/LOGIQ Fortis, K180374 Voluson S8/ S10/ S10 Expert, K202035 Vscan Air).
It outlines several non-clinical tests performed to ensure safety and compliance with standards:
- Acoustic output evaluation
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
The system states compliance with various voluntary standards including:
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance for Industry and Food and Drug Administration Staff (February 21, 2023)
- AAMI/ANSI ES60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility Requirements and Tests)
- IEC 60601-2-37 (Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment)
- IEC 62359 (Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields)
- ISO 10993-1 (Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process)
- ISO 14971 (Application of risk management to medical devices)
- NEMA PS 3.1 3.20e (Digital Imaging and Communications in Medicine (DICOM) Set)
- AAMI TIR69 (Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems)
Quality assurance measures applied during development include:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification & Validation)
- Safety testing (Verification)
The conclusion states that based on equipment design similarities, conformance to recognized performance standards, and performance testing, the proposed Venue Fit is considered substantially equivalent in safety, effectiveness, and performance to the predicate device.
Crucially, the document explicitly states: "The subject of this premarket submission, Venue Fit, did not require clinical studies to support substantial equivalence." This means that the information requested regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, and MRMC/standalone studies in a diagnostic performance context is not available within this document.
§ 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.