The Apache Ultrasound System is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional and superficial), Small Organ (including breast, scrotum, thyroid), Peripheral Vessel, Carotid, Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, M, PW and Combined (B+M; B+CD) modes. The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where is provided by trained healthcare professionals.

Device Description

The Apache Ultrasound System is a portable color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications through wireless communication with an off-the-shelf (OTS) mobile device. This system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode, M-Mode, PW mode and Color Doppler or a combination of these modes.

The Apache Probe processes the ultrasound signal and transfers real-time scan image data to the Apache App through the wireless connection with the mobile device. The 64-channel beamforming architecture of the probe maximizes the utility of all imaging transducer elements to enhance the diagnostic utility and confidence provided by the system. The Apache App provides the interface for mode/setting control and image display, acquisition, and storage functions. The Apache App is compatible with Android and iOS based mobile devices. Verified devices include Samsung Galaxy Tab S6, Samsung Galaxy Tab S7, Samsung Galaxy S10, Samsung Galaxy S21, Google Pixel 4, HTC U11, LG G85 ThinQ, iPhone 11, iPhone 12, iPad Pro 11-inch (Gen2), and iPad Air (Gen4).

The clinical environments where the system can be used include physician offices, clinics, hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high.

The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

AI/ML Overview

This FDA 510(k) summary for the Apache Ultrasound System does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The document states that the Apache Ultrasound System is a "Track 3 system" and that its substantial equivalence is primarily determined by comparison to a predicate device (Clarius Ultrasound Scanner K192107), specifically focusing on non-clinical performance tests rather than clinical efficacy studies in the way you've outlined.

Here's a breakdown of what the document does provide, and what it lacks in relation to your specific questions:

Key Takeaways from the Document:

Substantial Equivalence: The primary method for proving the device is acceptable is by demonstrating "substantial equivalence" to a legally marketed predicate device (Clarius Ultrasound Scanner K192107). This is a common pathway for medical devices where new clinical efficacy studies are not deemed necessary because the fundamental technology and intended use are similar to existing, cleared devices.
Focus on Non-Clinical Tests: The document explicitly states: "Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output. The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance."
No New Indications/Technologies Requiring Clinical Testing: "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices."

Addressing Your Specific Questions Based on the Provided Text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The document lists standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, IEC 62304, ISO 14971) that the device must comply with for non-clinical performance (electrical safety, EMC, usability, biological evaluation, software lifecycle, risk management). These standards implicitly define acceptance criteria in terms of meeting their requirements.
- Reported Device Performance: The document states, "The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance." However, it does not provide a detailed table with specific numerical performance metrics (e.g., measurement accuracy values, sensitivity values) or thresholds for these non-clinical tests. It merely states compliance.
Sample sized used for the test set and the data provenance:
- Not Applicable/Not Provided: Since the substantial equivalence is primarily based on non-clinical performance and a comparison to a predicate device without new clinical indications, there is no mention of a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The testing described is laboratory-based non-clinical testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided: This information pertains to studies involving human interpretation or ground truth establishment for diagnostic accuracy, which was explicitly not performed as a clinical study for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided: Same as above, not relevant for the type of submission 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:
- No: The document states, "Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing." This device is an ultrasound system itself, not an AI assisting human readers, and no MRMC study was performed as part of this 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This device is a diagnostic ultrasound system, not an AI algorithm intended for standalone performance evaluation in the usual sense of algorithm-only accuracy. Its "performance" is in generating images and fluid flow analysis, and its safety and effectiveness are established through engineering and non-clinical tests to meet standards.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Provided: For the non-clinical tests, "ground truth" would be defined by calibrated instruments, reference materials, and engineering specifications. It's not clinical "ground truth" (e.g., pathology, expert diagnosis).
The sample size for the training set:
- Not Applicable/Not Provided: This refers to the training of an AI model. While the device (like any modern medical device) contains software, the 510(k) summary does not describe it as an AI/ML-driven device that underwent a training phase on a specific dataset for diagnostic interpretation. Its software lifecycle processes are governed by IEC 62304, which is about software engineering, not AI model training.
How the ground truth for the training set was established:
- Not Applicable/Not Provided: Same as above.

In summary: The provided document is a 510(k) summary from the FDA, which outlines the basis for demonstrating "substantial equivalence" for a medical device. For the Apache Ultrasound System, this was primarily achieved through comparison to a predicate device and rigorous non-clinical testing against established safety and performance standards. It explicitly states that no new clinical efficacy testing was required because the device did not introduce new indications, modes, features, or technologies. Therefore, the detailed information about clinical studies, expert-derived ground truth, sample sizes for test/training sets, and AI-related performance metrics (like MRMC studies) you requested are not present in this type of submission for this particular device.

Summary

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June 25, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Aco Healthcare Co,. Ltd. % Henry Huang Manager of Product and Marketing Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung Hsinchu, 31057 TAIWAN (R.O.C.)

Re: K211232

Trade/Device Name: Apache 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: April 19, 2021 Received: April 23, 2021

Dear Henry Huang:

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K211232

Device Name Apache Ultrasound System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) __ Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D) 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." FORM FDA 3881 (6/20) Page 1 of 1 EF PSC Publishing Services (301) 443-6740

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510(K) Summary

K211232

Submitter:	Aco Healthcare Co,. Ltd.Address: Rm. 520, Bldg. 53, No. 195, Sec. 4, ChunghsingRd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.)+886-3-5820446
Official Contact:	Henry HuangAddress: Rm. 520, Bldg. 53, No. 195, Sec. 4, ChunghsingRd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.)
Email	Henry.huang@acohealthcare.com
Date Prepared:	April 19th, 2021
Device Name:	Apache Ultrasound System
Common Name:	Diagnostic Ultrasound System and Accessories
Regulation Number:	21 CFR 892.1550, 892.1560, 892.1570
Classification Name:	Ultrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic Transducer
Regulation Class	Class II
Product Code:	IYN
Subsequent Product Code:	IYO, ITX
Intended Use	Diagnostic ultrasound imaging and fluid flow analysis
Indications for Use:	The Apache Ultrasound System is intended for diagnosticultrasound imaging and fluid flow analysis in the followingapplications: Abdominal, Fetal/Obstetric, Gynecological,Fetal Echo, Musculo-skeletal (conventional andsuperficial), Small Organ (including breast, scrotum,thyroid), Peripheral Vessel, Carotid, Urology, andPediatric. The system provides diagnostic ultrasoundimaging in B, Color Doppler, M, PW and Combined (B+M;B+CD) modes. The clinical environments where thesystem can be used include physician offices, clinics,

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hospitals, and clinical point-of-care for diagnosis of patients except environments where intensity of electromagnetic disturbances is high. The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

Device Description

The Apache Ultrasound System is a portable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.

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Predicate Device

Equivalent devices are referred to as predicate devices in alignment with the FDA's standard terminology for comparable devices. The predicate device selected to demonstrate equivalence is the Clarius Ultrasound Scanner (K192107).

Determination of Substantial Equivalence

The subject device "Apache Ultrasound System" is a Track 3 system that adopt the same fundamental scientific technology as the predicate device "Clarius Scanner (K192107)". All indications for use introduced by the Apache Ultrasound System are same to at least one model of the predicate devices. Comparison between the predicate device and subject device is provided below:

Description	Subject Device	Predicate Device
	Apache Ultrasound System	Clarius Ultrasound System(K192107)
Product Name	Apache Ultrasound System	Clarius Ultrasound Scanner
Prescription/OTCuse	Prescription Use	Prescription Use
RegulationNumber	21 CFR 892.1550	21 CFR 892.1550
Product Code	IYN, IYO, ITX	IYN, IYO, ITX
510(k) Track	Track 3	Track 3
Intended Use	Diagnostic ultrasound imaging andfluid flow analysis	diagnostic ultrasound imaging andfluid flow analysis
Indications foruse		Ophthalmic
	Fetal	Fetal
	Abdominal	Abdominal
	Intraoperative (Abdominal organs &Vascular)
Small Organ (Thyroid, Scrotum,Breast)	Small Organ (Thyroid, Prostate,Scrotum, Breast)
	Cephalic (adult)
	Trans-rectal
	Trans-vaginal
Musculo-skeletal (conventional)	Musculo-skeletal (conventional)
Musculo-skeletal (superficial)	Musculo-skeletal (superficial)
Urology	Urology
Gynecology	Gynecology
	Cardiac (adult)
	Cardiac(pediatric)
Peripheral vessel	Peripheral vessel
	Needle guidance
Pediatric	Pediatric
Carotid	Carotid
Portability	Portable Ultrasound System	Portable Ultrasound System
Power Source	Li-Ion Battery	Li-Ion Battery
WirelessCommunication	Wireless communication via IEEE802.11g/n	Wireless communication via IEEE802.11g/n Bluetooth
Display andControl	Android or iOS mobile device	Android or iOS mobile device
Mode ofoperation	- B-Mode- M-Mode- Color Doppler- PW Doppler- Combined(B+M; B+CD)	- B-Mode- M-Mode- Color Doppler- Power Doppler- PW Doppler- Combined(B+M; B+CD; B+PD, B+PWD)

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Non-Clinical Test

Non-clinical performance tests include measurement accuracy, system sensitivity, thermal, mechanical, electrical safety, patient-contact materials, cleaning and disinfection, software and acoustic output.

The non-clinical test results show the device is compliant with the following standards, and it is safe and effective for its intended use and performance.

Reference No.	Title of Standard
AAMI/ANSIES60601-1	Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and EssentialPerformance AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 AndA2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: GeneralRequirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod). (General II(ES/EMC))
IEC 60601-1-2	Medical electrical equipment - Part 1-2: General requirements for basic safety andessential performance - Collateral Standard: Electromagnetic Capability - Requirementsand tests. (4th Edition)
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirements for basic safety andessential performance -Collateral standard: Usability
IEC 60601-2-37	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety andessential performance of ultrasonic medical diagnostic and monitoring equipment.
IEC 62133	Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - SafetyRequirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, ForUse in Portable Applications [Including: Corrigendum 1 (2013)]
IEC 62366	Consolidated Version Medical Devices - Application of Usability Engineering to MedicalDevices
ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within a riskmanagement process
ISO 10993-5	Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10	Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
IEC 62304	Medical Device Software - Software Life Cycle Processes
ISO 14971	Medical Devices - Applications of Risk Management to Medical Devices

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Quality assurance measures applied to the system design and development include, but were not limited to risk analysis, product specifications, design reviews and verification and validation.

Clinical Testing

Apache Ultrasound System introduces no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing. The clinical safety and effectiveness of ultrasound systems with these characteristics are well accepted for both predicate and subject devices.

Conclusion

Apache Ultrasound System is substantially equivalent to the predicate device. The Apache Ultrasound System function in a manner similar to and are intended for the same use as the predicate device. Based on the predicate device comparison of indications for use, labeling, acoustic output and general safety and effectiveness information, as well as the non-clinical performance test results, it is concluded that this device is as safe and effective as the predicate device for its intended use and performance, and is substantially equivalent to the predicate device.

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.