(97 days)
Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants. qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: · Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular. o abdominal, o small organs. o soft tissues and o musculoskeletal exams TRINITY is not indicated for ophthalmic and cranial ultrasonography. Medical Imaging Processing System 3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module, is indicated to: · Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI) · Fuse images of various modalities · Display organ and perform measurements · Display cartographies of prostate interventions (instrument positions) · Manage patient data · Import and export of data and images
TRINITY is an electro medical system considered as a system composed of: - A mobile workstation composed by a central unit with ultrasound beamformer, a tactile ● screen, a mouse, a touch pen and a footswitch, all assembled on a mobile cart. Options, as keyboard and trackball mouse, can be delivered. - 0 Ultrasonic probe: 2D/3D end-fire endocavity probe and/or 2D/3D side-fire endocavity probe. 2D probes can be optionally delivered. - 3D PROSTATE SUITE software composed of the base software and PROMAP –Ty that drives the 0 ultrasound module and performs additional measuring functions. The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz. Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging (including color flow sub-mode and power sub-mode) for body fluid flow analysis. - B-mode imaging measures the time and waveform differences between wave emission and o wave reception to reconstruct an image. - 0 Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement) (color flow sub-mode) or to show flow strength (power sub-mode). The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.
This document is a 510(k) Summary for the KOELIS TRINITY / 3D PROSTATE SUITE device. It establishes substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria for new features or AI-driven improvements. As such, it does not contain the detailed study information typically associated with proving a device meets acceptance criteria for novel algorithms, especially those involving AI.
Therefore, many of the requested fields cannot be directly populated from the provided text. The device is primarily an ultrasound system with associated software for processing and visualizing images, and the application focuses on expanding its indications for use and adding a new probe. The "Summary of Clinical Tests" explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."
Based on the provided text, here's an attempt to answer the questions:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported quantitative performance metrics for the TRINITY / 3D PROSTATE SUITE in the context of novel algorithmic performance or AI. The acceptance is based on demonstrating substantial equivalence to existing predicate devices for similar clinical applications and modalities, and compliance with various safety and performance standards.
The criteria for acceptance appear to be:
- Substantial Equivalence: Demonstrated through comparison of intended use, imaging capabilities, technological characteristics, scientific backgrounds, safety, and effectiveness to predicate devices (K160357 TRINITY and K160182 Logiq S7 expert).
- Safety Standards Compliance: Meeting voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
- Quality Assurance Measures: Application of risk analysis, requirements reviews, design reviews, varying levels of testing (unit, integration, final acceptance, performance, safety).
Since no new algorithmic performance (e.g., AI accuracy) is being claimed or evaluated, there are no reported quantitative performance metrics against these criteria beyond the statement that the device is "as safe, as effective, and performance is substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance
As stated, "The subject of this premarket submission did not require clinical studies to support substantial equivalence." Therefore, there is no clinical "test set" with patient data in the typical sense for evaluating a novel algorithm's performance. The "testing" referred to is against engineering and safety standards, not clinical performance on a dataset of images with ground truth.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts for algorithmic performance evaluation was described as part of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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 such study was conducted or reported in this 510(k) summary. The device's substantial equivalence is based on its core functionality as an ultrasound system and imaging processing system, not on AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI-driven diagnostic algorithm. It's an imaging system and processing software. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable here. The system's performance is intrinsically tied to its ability to generate, process, and display images for human interpretation and procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study involving ground truth for an algorithm was conducted.
8. The sample size for the training set
Not applicable, as this is not an AI/ML submission describing a model trained on a dataset.
9. How the ground truth for the training set was established
Not applicable.
§ 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.