(280 days)
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer.
The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage.
The provided text describes the ULTIMUS Series Ultrasound Diagnostic System (K240676) and its substantial equivalence to a predicate device (GE LOGIQ E10 Ultrasound Diagnostic System, K231966). However, the document does not contain information about specific acceptance criteria related to device performance in terms of diagnostic accuracy or effect size with AI assistance. Instead, the acceptance criteria are focused on the device's adherence to regulatory standards, safety, and functional equivalence to the predicate device.
Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:
Acceptance Criteria and Reported Device Performance
The document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific clinical task) and reported device performance. The "acceptance criteria" discussed are largely regulatory and safety compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant medical device safety standards | The ULTIMUS Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. (A list of 16 standards is provided). |
| Substantial equivalence in intended use, indications for use, image capabilities, technological characteristics, image mode, and safety effectiveness to predicate device (GE LOGIQ E10) | The Proposed ULTIMUS Series system are substantially equivalent to the predicate GE LOGIQ E10 Ultrasound Diagnostic System (K231966) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness. (Detailed comparison tables are provided, highlighting similarities). |
| Patient contact materials meet ISO 10993-1 and FDA guidance | Material meet ISO 10993-1 and FDA guidance. |
| Acoustic output within specified limits (Track 3) | Ispta.3 ≤ 720 mW/cm2, MI ≤ 1.9, TI ≤ 6.0 (same as predicate). |
| Labeling conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 (same as predicate). |
Missing Information Based on Your Request:
The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."
Therefore, the following information, which would typically come from clinical studies or performance validation studies, is not available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable as no clinical studies were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 document does not mention AI assistance as a feature of the device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not an AI algorithm for standalone diagnostic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering, safety, and functional comparisons, rather than clinical performance studies.
§ 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.