The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan™ Mode, Multi-Image mode(Dual, Quad), Combined modes, 3D/4D mode

Device Description

The RS85 / RS80 EVO are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode, MV-Flow Mode or as a combination of these modes.

The RS85 / RS80 EVO also give the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals.

The RS85 / RS80 EVO have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

AI/ML Overview

The provided document, a 510(k) summary for the Samsung Medison RS85 / RS80 EVO Diagnostic Ultrasound System, does not contain the detailed acceptance criteria and performance study information typically required for an AI/ML-based medical device.

The document explicitly states in section 12: "The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device (RS85 Diagnostic Ultrasound System K192903) through non-clinical testing, rather than a performance study involving AI/ML components with specific acceptance criteria.

The information provided pertains to general ultrasound system functions, safety standards, and technological equivalence to a previous model, not to the performance of an AI-driven feature.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details for an AI component from this document.

To answer your request, if this were a document for an AI/ML-driven device, the following would typically be observed:

A table of acceptance criteria and the reported device performance: This would be found in a dedicated section detailing the clinical or technical validation of the AI feature. It would list performance metrics (e.g., sensitivity, specificity, AUC, accuracy) with pre-defined thresholds and the actual values achieved by the device.
Sample sized used for the test set and the data provenance: This information would be crucial for evaluating the robustness and generalizability of the AI model. It would include the number of cases/patients in the test set, their demographic breakdown, and where the data was collected (e.g., single-center, multi-center, specific countries), and whether it was collected retrospectively or prospectively.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For expert consensus ground truth, the number of readers, their specialty (e.g., board-certified radiologists), and years of experience would be detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: If multiple experts were used to establish ground truth, the method for resolving discrepancies (e.g., majority vote, senior expert arbitration) would be described.
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: This would be a specific section demonstrating the human-AI team performance, often comparing reader performance with and without AI assistance using metrics like AUC, sensitivity, or specificity, and reporting the statistically significant improvement (effect size).
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Often, an AI model's standalone performance is evaluated first, before assessing its impact in a human-in-the-loop setting.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This would specify the "gold standard" against which the AI's performance was measured.
The sample size for the training set: The number of cases/patients used to train the AI model would be an important detail to understand the model's learning capacity.
How the ground truth for the training set was established: The method for labeling or annotating the data used for training the AI model would be described.

In summary, the provided document focuses on the substantial equivalence of a general diagnostic ultrasound system and its transducers, rather than the performance evaluation of an AI/ML-driven component within such a system.

Summary

{0}------------------------------------------------

June 24, 3021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Samsung Medison Co., LTD. % Scully Kim Regulatory Affairs Specialist 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA

Re: K210959

Trade/Device Name: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 25, 2021 Received: May 27, 2021

Dear Scully Kim:

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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210959

Device Name RS85 Diagnostic Ultrasound System RS80 EVO Diagnostic Ultrasound System

Indications for Use (Describe)

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SAMSUNG MEDISON CO., LTD.

K210959

RS85 / RS80 EVO Diagnostic Ultrasound System

510(K) Summary:

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

Date Prepared March 29, 2021 1.
1. Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do 25108, REPUBLIC OF KOREA
1. Primary Contact Person Scully Kim Regulatory Affairs Specialist Phone: +82.2.2.2194.1312 Fax: +82. 2.2194.0273 Email: scully.kim@samsungmedison.com
1. Secondary Contact Person Ninad Gujar Vice President of Regulatory & Quality Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
1. Proposed Device

Common Name:	Diagnostic Ultrasound System and Accessories
Trade/Device Name:	RS85 Diagnostic Ultrasound SystemRS80 EVO Diagnostic Ultrasound System
Additional Marketing Name :	RS85 Prestige Diagnostic Ultrasound System
Regulation Name:	Ultrasound pulsed Doppler imaging system
Panel/ Regulatory Class:	Radiology / II
Product Code:	IYN, IYO, ITX
Regulation No.	892.1550, 892.1560, 892.1570

1. Predicate Device
- RS85 Diagnostic Ultrasound System (K192903)
1. Device Description

The RS85 / RS80 EVO have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

{4}------------------------------------------------

8. Indications for Use

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and Peripheral vessel.

9. Technologv

The RS85 / RS80 EVO employ the same fundamental scientific technology as its predicate device.

1. Determination of Substantial Equivalence
  Comparison to Predicate: The RS85 / RS80 EVO are substantially equivalent to the predicate device with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. ●
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have the same clinical intended use.
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have the same imaging modes and modes of operation.
. The proposed RS85 / RS80 EVO added two new transducers (LA4-18A, LA3-22AI).
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
. The proposed RS85 / RS80 EVO and predicate RS85(K192903) have been designed in compliance with approved electrical and physical safety standards
. The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
. The systems have acoustic power levels which are below the applicable FDA limits.

RS85 and RS80 EVO are the same systems that provide only different option configurations. There is an addition of new transducers (LA4-18A, LA3-22AI) compare to previously cleared RS85 (K192903) system.

The material and design changes of MMPT3-7 transducer will be applied to all SAMSUNG

{5}------------------------------------------------

MEDISON products after 510(k) clearance.

The material change of Endocavity transducers (EV2-10A, EA2-11AR/EA2-11AV) will be applied to all SAMSUNG MEDISON products after 510(k) clearance.

11. Summary of Non-Clinical Test

The proposed devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The RS85 / RS80 EVO and its applications comply with voluntary standards.

Test	Standards and FDA Guidance
Risk Management	ISO 14971 Second edition 2007 Medical devices - Application of riskmanagement to medical devices
Electrical Safety	ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012Medical Electrical Equipment - Part 1: General Requirements for basic safetyand essential performance.
ElectromagneticCompatibility	IEC60601-1-2: 2014(4th Edition) Medical Electrical Equipment -- Part 1-2:General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
Biocompatibility	AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a risk management process
Reprocessing MedicalDevices	FDA Guidance: Reprocessing Medical Devices in Health Care Settings:Validation Methods and Labeling issued on March 17, 2015, revised June 9,2017.
Software/Firmware-driven Functionality	All migrated software functionality was evaluated using the same test criteria asthe predicate for all applicable imaging modes to ensure that migration into anew system design did not compromise image quality with respect to theintended use of each feature.Guidance for the Content of Premarket Submissions for Software Contained inMedical Devices issued on May 11, 2005
Ultrasound Safety	Marketing Clearance of Diagnostic Ultrasound Systems and Transducers issuedJune 27, 2019IEC60601-2-37:2007 + A1:2015, Particular requirements for the safety ofultrasonic medical diagnostic and monitoring equipmentNEMA UD 2-2004 (R2009)Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentRevision 3

12. Summary of Clinical Tests

The subject of this premarket submission, RS85 / RS80 EVO, did not require clinical studies to support substantial equivalence.

13. Conclusion

SAMSUNG MEDISON considers the RS85 and RS80 EVO to be as safe, as effective, and performance is substantially equivalent to the predicate device.

{6}------------------------------------------------

END of 510(K) Summary

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.