(20 days)
The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. including mechanical and electronic scanning transducers, which highly accurate real-time three-dimensional provide imaging supporting all standard acquisition modes. Voluson E10 is identical in hardware and software compared to the Voluson E8 and Voluson E6 with the exception of scan channels. Voluson E10 has more than Voluson E8 and E6. Voluson E10 also has additional hardware for the 4D electronic probes: eM6C and eM6C G2. The basic software is the same as the predicate and no additional software functions were added in this submission.
The provided document is a 510(k) Premarket Notification Submission for GE Healthcare's Voluson E Series ultrasound systems. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics for a new clinical application.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not available in this document. This submission details an update to existing devices with improved hardware and minor software improvements, asserting that the intended use and performance remain substantially equivalent to the previously cleared predicate.
Here's what can be extracted and what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new clinical performance study. The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics, safety standards, and intended use as described in the "Determination of Substantial Equivalence" section. Implicitly, the acceptance criteria are that the updated device must meet the same safety, effectiveness, and performance levels as its predicate, especially concerning acoustic output, electrical/thermal/mechanical safety, biocompatibility, and software functionality.
- Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this document as it's not a clinical performance study. The document states:
- "The proposed Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness."
- "The proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use."
- "The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes."
- "The proposed Voluson E Series and predicate Voluson E Series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
- "The systems have acoustic power levels which are below the applicable FDA limits."
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/Not provided. This submission did not involve a clinical study with a test set of patient data to evaluate performance for a new clinical claim. It's a technical and regulatory review for substantial equivalence.
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/Not provided. No clinical ground truth was established as no clinical study was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical study was performed.
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. This document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted. Also, the device is a general-purpose ultrasound system with improved hardware and existing software features, not an AI-assisted diagnostic tool discussed in the context of improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This submission is for an ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No new clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence primarily relies on technical specifications, adherence to safety standards, and documented equivalence to a legally marketed predicate device's performance, which was presumably established in its original clearance.
8. The sample size for the training set
- Not applicable/Not provided. As no new clinical algorithm with a training set is discussed or developed in this submission, this information is not relevant. The software improvements mentioned are to existing features, implying an iterative development process rather than a new AI model requiring a separate training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No new training set or associated ground truth establishment is described in 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.