(291 days)
ArtUs is a general purpose diagnostic ultrasound imaging system intended for use by qualified and appropriately trained healthcare professionals to conduct ultrasound scan process or fluid flow analysis of the human body.
It is intended to be used for applications in Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicles), Musculo-Skeletal Conventional and Superficial, Cardiac (adult and pediatric), Adult Cephalic, and Peripheral Vascular.
Modes of operation include B, M, Pulse Wave Doppler (CFM), Power Doppler (CFM), Power Doppler (PDI), Directional Power Doppler (DPDI), Combined modes (B+B, B+M, 4B, B+PWD (Duplex), B+CFM/PDI/DPDI+PWD (Triplex)), Tissue Harmonic Imaging (THI) and Inverted Tissue Harmonic Imaging (ITHI).
The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients.
ArtUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.
ArtUs system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 MHz.
The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode, M-Mode or combined modes, inclusive of the predicate devices so claimed.
The ArtUs only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the ArtUs via USB 3.0. Minimum requirements are given for the PC.
The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC.
The device variant is:
- ArtUs EXT-1H ultrasound system utilizing as hardware an ultrasound engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply;
The ArtUs can be used together with the appropriate transducers for the entire ultrasound diagnostic (2MHz to 15MHz probes).
This document is a 510(k) Pre-market Notification for the ArtUs ultrasound system. It claims substantial equivalence to predicate devices and focuses on technical specifications, safety, and regulatory compliance.
Crucially, this document does not contain information about studies proving the device meets specific acceptance criteria related to its diagnostic performance. It focuses on engineering acceptance criteria (e.g., meeting safety standards, biocompatibility, acoustic output, software functionality) and demonstrating substantial equivalence to previously cleared devices rather than novel diagnostic efficacy.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain the required information for diagnostic performance studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for substantial equivalence based on safety and technical performance rather than diagnostic accuracy, the acceptance criteria are generally related to compliance with standards and equivalence to predicate devices. No diagnostic performance metrics (e.g., sensitivity, specificity) are provided.
| Acceptance Criteria Category | Reported Device Performance (Summary from document) |
|---|---|
| General Safety and Effectiveness | Designed for compliance to all applicable medical device safety standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, ISO 10993-1, ISO 10993-5, ISO 10993-10). |
| Tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning, and disinfection effectiveness. | |
| Maximum acoustic output level under FDA recommended limit and power level displayed all the time (ALARA principle adherence). | |
| Biocompatibility | Patient contact materials (Acoustic Lens, Transducer Housing / Silicone Elastomer, Plastic) conform to ISO-10993-1, ISO-10993-5, ISO-10993-10. |
| Software | Hardware and firmware collect and pre-process "rough" data. Main application software (Echo Wave II) on PC receives, processes, and displays medical images/data. |
| Substantial Equivalence to Predicate Devices (SmartUs, SONOACE R7) | Uses the same fundamental scientific technology (transmits ultrasonic energy, performs post-processing of received echoes to generate on-screen display of anatomic structures and fluid flow). |
| Successor to existing licensed device SmartUs. | |
| Meets FDA requirements for Track 3 devices, has biosafety equivalence. | |
| Differences (smaller, lighter, USB 3.0, new connectors) have no impact on safety or efficacy, do not raise new risks, and device is equivalent in performance to legally marketed devices. |
For points 2 through 9, the document explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices." This means there was no diagnostic performance study with a test set of patients to establish accuracy metrics such as sensitivity, specificity, or reader performance.
Therefore, the following points cannot be addressed from the provided text:
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, no diagnostic performance test set described.
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, no ground truth for a diagnostic test set described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* Not applicable, no diagnostic test set described.
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. This document describes an ultrasound device, not an AI-powered diagnostic algorithm for clinical interpretation. It does not mention AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is not an AI algorithm submission seeking standalone diagnostic performance clearance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Not applicable for diagnostic performance. Ground truth for safety and technical performance would be based on standard engineering and biocompatibility testing procedures.
8. The sample size for the training set
* Not applicable. This document is not for an AI algorithm that would typically have a training set.
9. How the ground truth for the training set was established
* Not applicable. This document is not for an AI algorithm.
§ 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.