(13 days)
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Conventional & Superficial; Intraoperative Vascular: Musculoskeletal (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a stand or mobile cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display. It utilizes interchangeable electronic-array transducers with digital acquisition, processing and display capability operating. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Venue 40 Compact Ultrasound:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Premarket Notification for the GE Venue 40 Compact Ultrasound, does not explicitly state specific acceptance criteria or quantitative performance metrics for the device itself.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (GE LOGIQ e Diagnostic Ultrasound K072797). This means the acceptance criteria are implicitly tied to the safety and effectiveness profile of the predicate device.
The "reported device performance" is primarily qualitative, asserting that the Venue 40 has "the same overall characteristics, key safety and effectiveness features, physical overall construction, and materials" as the predicate, with "less intended uses and operating modes."
| Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantially equivalent to GE LOGIQ e (K072797) in terms of safety and effectiveness. | "The GE Venue 40 is of a comparable type and substantially equivalent to the current GE LOGIQ e with overall performance in a small and compact package." |
| Characteristics | Same overall characteristics as the predicate. | "It has the same overall characteristics..." |
| Safety Features | Same key safety features as the predicate. | "...key safety and effectiveness features..." |
| Effectiveness Features | Same key effectiveness features as the predicate. | "...key safety and effectiveness features..." |
| Construction/Materials | Same physical overall construction and materials as the predicate. | "...physical overall construction, and materials..." |
| Intended Uses/Operating Modes | Comparable or lesser intended uses and operating modes than the predicate. | "...and has the less intended uses and operating modes as the predicate device." (Indications for Use are listed, but no direct comparison to the predicate's full list is provided beyond this general statement) |
| Non-clinical Tests | Conformity to applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection, EMC, thermal, electrical safety. | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical safety, and has been found to conform with applicable medical device safety standards." |
| Quality Systems | Compliance with 21 CFR 820, ISO 9001:2000, and ISO 13485. | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not applicable / None. The document explicitly states "Clinical Tests: None required." The demonstration of substantial equivalence did not involve a clinical test set of patients or data.
- Data Provenance: Not applicable, as no clinical test set was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable, as no clinical test set was used.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no clinical test set was used.
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
- MRMC Study: No. This device is an ultrasound imaging system, not an AI-powered diagnostic tool requiring a human-in-the-loop study in this context. The submission predates widespread AI integration into medical devices for diagnostic assistance.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: No. This device is a diagnostic ultrasound machine, which inherently requires a human operator and interpretation. There is no mention of an "algorithm only" performance evaluation in the context of AI.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for a clinical test set, as no such test was conducted. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not explicitly mentioned. Since this is not an AI/machine learning device in the contemporary sense, there isn't a "training set" for an algorithm. The development of the device would have involved engineering, design, and manufacturing processes, but not a data-driven training set for an AI model.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI algorithm. The device's "ground truth" for its design and manufacturing is adherence to engineering specifications, safety standards, and performance benchmarks that ensure its functionality and image quality are comparable to the predicate.
§ 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.