(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follice development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal (Conventional and Superficial); Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
The Voluson i is a compact, general purpose diagnostic ultrasound system which consists of a portable console, approximately 313 mm wide, 313 mm deep and 59 mm high when closed. It has an integrated acquisition, processing and display unit and a notebook-like user interface consisting of a keyboard and trackball. This configuration will provide users with enhanced convenience and portability.
The provided text describes a 510(k) premarket notification for the GE Voluson i Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing new performance criteria through clinical trials. Therefore, the information typically found in an AI/ML device's acceptance criteria and study section (like specific metrics, sample sizes for test/training sets, expert qualifications, and detailed ground truth establishment) is not present.
Based on the provided text, here’s a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are described for the Voluson i ultrasound system beyond general safety and effectiveness. The document states that "The device has been evaluated for acoustic output, biocompatibility, beaming and electrical safety, and has been found to conform with applicable medical device safety standards." No specific performance metrics or their values are reported for the Voluson i in comparison to a predicate device in the context of quantitative acceptance criteria. Instead, the "performance" is implicitly demonstrated through the claim of "substantially equivalent" to predicate devices.
The "Indications for Use" forms for each transducer (12L-RS, PA2-5-RS, E8C-RS, RAB2-5-RS, RSP6-16-RS, RIC5-9-RS, 4C-RS) describe the modes of operation and clinical applications for which the device is intended. These are not performance metrics but rather definitions of intended use. The "P" (previously cleared by FDA) and "N" (new indication) markers indicate the scope of the device's capabilities relative to prior clearances but do not provide quantitative performance data.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "2. Clinical Tests: None required." This indicates that no clinical tests were performed or deemed necessary to demonstrate the safety and effectiveness of the Voluson i system for this 510(k) submission. Therefore, there is no test set sample size or data provenance to report from this document. The assessment was based on non-clinical tests and comparison to predicate devices already on the market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since no clinical tests were performed, there was no "ground truth" to establish for a test set in the context of this submission. The determination of substantial equivalence relies on the known safety and effectiveness of predicate devices, which would have undergone their own validation processes.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical tests were performed and thus no test set with ground truth requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: None required." The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the effectiveness of human readers with and without AI assistance (as this is an ultrasound system, not an AI diagnostic tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable for this type of device. The Voluson i is a diagnostic ultrasound system, an imaging modality operated by a human, not a standalone AI algorithm. Its performance is intrinsically tied to human operation and interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical tests requiring the establishment of a novel ground truth were performed for this submission. The ground truth for the predicate devices would have been established through their own clearance processes, but this is not detailed here.
8. The Sample Size for the Training Set:
Not applicable. The Voluson i is a diagnostic ultrasound system. The document does not describe any machine learning components that would require a "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the same reason as above.
Summary of the Study and Device Assessment (based on the provided text):
The GE Voluson i Diagnostic Ultrasound System's acceptance was based on a 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices.
The study that "proves" the device meets acceptance criteria is primarily non-clinical testing and a comparison to predicate devices:
- Non-clinical Tests: The device underwent evaluations for "acoustic output, biocompatibility, beaming and electrical safety" and was found to conform with applicable medical device safety standards.
- Comparison with Predicate Devices: The Voluson i is described as being "of a comparable type and substantially equivalent... to the unmodified Voluson 730 Pro/Expert and also to the comparable type and substantially equivalent... The same technological characteristics, key safety and effectiveness features, and similar physical design, construction, and materials." (K003525, K032620, K041688 were the predicate devices).
- Clinical Tests: The document explicitly states "None required."
- Conclusion: GE Healthcare's opinion is that the Voluson i Diagnostic Ultrasound System is "substantially equivalent to devices currently cleared for market," based on its conformance to safety standards, quality systems, and the established safe and effective performance history of GE Healthcare products.
In essence, for this 510(k) clearance, the "acceptance criteria" were met by demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing and technological comparison, without requiring new clinical trials to establish novel performance metrics or ground truth.
§ 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.