(16 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral (Fransredi, Myrold Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
The Voluson 730 Pro/Expert are full featured, general purpose diagnostic ultrasound systems. They consists of a mobile console approximately 68 cm wide, 100 cm deep and 145 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color LCD display (Expert) and color CRT. This modification will provide users with additional probe options, improved user interface and image enhancement.
Here's an analysis of the provided text regarding the GE Voluson 730 Pro/Expert Diagnostic Ultrasound System (K041688) and its associated transducers, focusing on acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation is a 510(k) premarket notification for substantial equivalence, not a clinical trial report with specific quantitative performance metrics and acceptance criteria for a new AI/software component. Therefore, there are no explicit numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) or reported device performance for an AI/software feature in this document.
Instead, the "acceptance criteria" here are based on:
- Substantial Equivalence: The device being comparable in type, technological characteristics, safety, effectiveness, physical design, construction, materials, and intended uses to existing cleared predicate devices (Voluson 730 Pro/Expert K003525, K032620, and GE LOGIQ 9).
- Compliance with Standards: Conformance with applicable medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety).
- Quality System Compliance: The design and development process conforming to 21 CFR 820, ISO 9001, and ISO 13485 quality systems.
- Intended Use Consistency: Intended uses and key features being consistent with traditional clinical practice and FDA guidelines.
Since no specific AI performance metrics are stated as "acceptance criteria," the table for "reported device performance" would also be empty in this context.
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Voluson 730 Pro/Expert BT04 is of a comparable type and substantially equivalent to the current GE Voluson 730 Pro/Expert and GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device." |
| Compliance with Applicable Medical Device Safety Standards | "The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." "The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance." |
| Conformance with Quality Systems (21 CFR 820, ISO 9001, ISO 13485) | "The design and development process of the garantischurer conforms with 21 CFR 820, ISO 9001and ISO 13485 quality systems." |
| Consistency with Traditional Clinical Practice & FDA Guidelines | "Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." |
| Safe and Effective Performance | "Diagnostic ultrasound has accumulated a long history of safe and effective performance." (This refers to general diagnostic ultrasound technology, not specifically new features in this submission). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: None required." This indicates that no new clinical study was conducted with a test set of patient data for this 510(k) submission. The substantial equivalence relies on the established safety and effectiveness of the predicate devices and the general understanding of diagnostic ultrasound technology.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical tests or test sets were used for this specific submission, there were no experts used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no test set was used 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
Not applicable. The submission does not describe an AI component or a comparative effectiveness study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The submission does not describe a standalone algorithm or AI performance. The modifications primarily involve "additional probe options, improved user interface and image enhancement" for an existing ultrasound system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical data analysis requiring ground truth was performed for this specific submission. The approval is based on substantial equivalence to existing, already cleared devices whose safety and effectiveness were established through other means, including potentially clinical experience and regulatory review of their original submissions.
8. The Sample Size for the Training Set
Not applicable, as no new clinical data or AI development requiring a training set is described in this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used or required for this submission.
§ 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.