(84 days)
TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.
The device is indicated to generate, visualize and record 2D and 3D ultrasound images.
In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.
Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).
Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.
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 these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
- Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe.
- 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform 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 for body fluid flow analysis.
- B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image.
- . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement).
The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.
The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.
This document is a 510(k) Premarket Notification from the FDA regarding the TRINITY Ultrasound and Medical Imaging Processing System. While it provides detailed information about the device's intended use, technological characteristics, and compliance with safety standards, it explicitly states that "The subject of this premarket submission did not require clinical studies to support substantial equivalence."
Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because a clinical study was not performed as part of this submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study.
Here's what can be inferred from the document regarding the information requested, based on the absence of a clinical study:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided because no clinical study was conducted. The document focuses on demonstrating equivalence to predicate devices based on technical specifications and non-clinical tests.
2. Sample size used for the test set and the data provenance:
- Not applicable, as no clinical test set was used for a study proving device performance.
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 requiring ground truth was used for a study proving device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication was used for a study proving device performance.
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. No MRMC study was performed. The device is an ultrasound system and processing software, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study comparing human readers with and without AI assistance for a specific clinical task.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The TRINITY system is an ultrasound and medical imaging processing system intended to be used by clinicians. It is not an algorithm-only standalone diagnostic tool. Its performance is inherent to the generation, visualization, and recording of ultrasound images, and processing of 3D digital ultrasound images for tasks like organ mapping (with the 3D PROSTATE SUITE SOFTWARE).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical study required establishing ground truth for performance evaluation of "new" clinical results.
8. The sample size for the training set:
- Not applicable, as no clinical study with a training set was performed for this submission. The device leverages existing technology and previously cleared software (UROSTATION - 3D PROSTATE SUITE, K131448).
9. How the ground truth for the training set was established:
- Not applicable, as no clinical study with a training set was performed for this submission.
Summary from the document:
- Basis for Approval: Substantial equivalence to predicate devices (LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K141261, and UROSTATION - 3D PROSTATE SUITE (KOELIS) K131448).
- Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety were evaluated and found compliant with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
- Clinical Studies: None were required or performed for this premarket submission to support substantial equivalence.
§ 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.