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.

Device Description

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).

AI/ML Overview

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.

Summary

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Telemed % Yury Sokolov QA/RA Manager Highway Business Centre Savanoriu pr. 178A Vilnius, LT-03154 LITHUANIA

February 11, 2022

Re: K211248 Trade/Device Name: ArtUs Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 30, 2021 Received: January 10, 2022

Dear Yury Sokolov:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211248

Device Name ArtUs

Indications for Use (Describe)

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-ofcare for diagnosis of patients.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.92 the following summary of information is provided:

K211248 -510k Summary

1. Identifying information

Manufacturer TELEMED Device Trade Name ArtUs Highway Business Centre Savanoriu pr. 178A Address Vilnius, LT-03154, Lithuania Telephone +370-5 2106272 +370-5 2106273 +370-5 2306733 Fax Web http://www.pcultrasound.com/ www.telemed.lt info@telemed.lt E-mail Yury Sokolov / QA Manager PRRC yury@pcultrasound.com Contact Person Date 510(k) Summary Prepared December 30, 2021

2. Class and Predicate Information

Classification Name	Regulation Number	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	IYO
Diagnostic Ultrasonic Transducer	892.1570	ITX
Common Name	Diagnostic Ultrasound System
Propietary Name	ArtUs
Classification	Regulatory Class II
Predicate Device	TELEMEDSAMSUNG MEDISON	SmartUsSONOACE R7	K163121 K112646

3. LIST OF CONSENSUS STANDARDS

The proposed device ArtUs is in conformity with the requirements of the following consensus standards:

[Rec. # 19-4] ANSI/AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for safety and essential performance,

[Rec. # 19-8] IEC 60601-1-2 Medical electrical equipment --Part 1-2 General requirements for safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests

[Rec. # 12-293] IEC 60601-2-37 Medical electrical equipment -Part 2-37; Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

[Rec. # 13-79] IEC 62304 Medical device software - Software life cycle processes [Rec. # 5-114] IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices

[Rec. # 5-125] ISO 14971 Medical devices - Application of risk management to medical devices [Rec. # 5-117] ISO 15223-1 Medical devices - Symbols to be used with medical device labels labelling and information to be supplied - Part 1: General requirements

[Rec. # 2-220] ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

[Rec. # 2-245] ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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[Rec. # 12-293] ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

4. Indication for Use

Modes of operation include B. M. Pulse Wave Doppler (PWD). Color 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.

5. Device Description

ArtUs system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning.

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).

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. Transducer L15-7H40-A5, linear array, at a central frequency of approx. 12 MHz
. Transducer C5-2H60-A5, convex array at a central frequency of approx. 3.5 MHz;
Transducer P5-1S15-A6, phased array at a central ultrasonic frequency of approx. 4 MHz .

6. General Safety and Effectiveness.

The ArtUs ultrasound system and its accessories are designed for compliance to all applicable medical devices safety standards, as referenced in Declaration of Conformity. Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness.

. No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices.
. Maximum acoustic output level is under by the FDA recommended limit and power level is displayed all the time.
. The system's acoustic output is in accordance with ALARA principle (As Low As Reasonably Achievable)

7. Patient Contact Materials

The parts / materials of the transducer, coming in contact with patient are:

. Acoustic Lens, Transducer Housing / Silicone Elastomer, Plastic
Standards for the biological evaluation:
. ISO-10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process
ISO-10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro ● cytotoxicity
ISO-10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for irritation ● and skin sensitization

8. Software

The ArtUs system contains the hardware and software which collect and pro-processes 'rough" data and send it via USB 3.0 connection to a Windows® based PC.

The main application software is Echo Wave II software running on the PC, it is receiving data, processing and showing image/data on the screen. The main user interface shows an ultrasound image, controls and drop-out menus. The ultrasound images and calculated/measured data can be stored in memory.

9. Determination of Substantial Equivalence

The ArtUs color Doppler ultrasound system is similar to currently distributed ultrasonic pulsed echo imaging systems SmartUs (TELEMED) and SONOACE R7 (SAMSUNG MEDISON) in terms of both the intended use and technological characteristics. The ArtUs (subject device) uses the same

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fundamental scientific technology as the predicate devices. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body.

This device ArtUS is a successor of an existing licensed device SmartUs (cleared via K163121) using technologies that exist on the market as of the date of this submission.

In cosmetic design, the subject device (ArtUs) has a smaller and lighter structure and appearance than SmartUs due to modern electronic components.

The PCBs in the system are minimized in their size and layout, while the overall circuit operation principle is not changed.

The connection of new ultrasound transducers is easier and more reliable using the new generation of connectors.

The connection to the PC by USB 3.0 (comparing USB 2.0 connection for SmartUs) is increasing the dataflow performance between the device and PC.

The subject device ArtUs meets FDA requirements for Track 3 devices, have biosafety equivalence, and conform to applicable electromedical devices safety standards. All the safety and performance tests of the device meet the essential requirements.

Therefore, the system has the same classification and is substantially equivalent to predicate devices.

Any differences between the predicate and the new device have no impact on safety or efficacy of the new device and do not raise any new potential or increased safety risks, and the new device is equivalent in performance to existing legally marketed devices.

10. Conclusion

In accordance with the FDA and based on the information provided in this Premarket notification, TELEMED considers the ArtUs to be as safe as effective and performance is substantially equivalent to the predicate devices described herein.

Regulation Number and Section

§ 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.