The Apache Ultrasound System (Model: C62) is intended for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric. The system provides diagnostic ultrasound imaging in B, Color Doppler, and M 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 healthcare 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 and Color Doppler or a combination of these modes. The Apache 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 user interface for mode/setting control and image display, acquisition and storage functions. The Apache App is compatible with Android based mobile devices. Verified devices include Samsung Galaxy S10, Google Pixel 4, HTC U11, and LG G85 ThinQ.

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

The provided text describes a 510(k) premarket notification for the "Apache Ultrasound System (Model C62)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through the kind of studies typically performed for AI/ML-based diagnostic devices (e.g., studies evaluating sensitivity, specificity, or reader performance).

Therefore, many of the requested details regarding acceptance criteria for diagnostic performance and specific study methodologies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not present in this type of FDA submission.

Instead, this submission primarily relies on:

Comparison to a Predicate Device: Demonstrating that the new device has the same intended use, indications for use, and similar technological characteristics as a legally marketed device.
Compliance with Non-Clinical Standards: Showing that the device meets established safety and performance standards for ultrasound equipment (e.g., electrical safety, electromagnetic compatibility, acoustic output, usability, biocompatibility, software lifecycle, risk management).

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent or not applicable to this type of submission:

Acceptance Criteria and Device Performance (as per 510(k) for substantial equivalence)

Since this is a substantial equivalence submission for an ultrasound imaging system, the "acceptance criteria" are primarily related to safety, fundamental performance characteristics, and similarity to the predicate device, rather than diagnostic accuracy metrics of an AI/ML algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k))	Reported Device Performance (as per text)
Intended Use Equivalence: Same as predicate device.	Stated Equivalence: "All indications for use introduced by the Apache Ultrasound System are same to at least one model of the predicate devices."Subject Device Stated Intended Use: "Diagnostic ultrasound imaging and fluid flow analysis."Predicate Device Stated Intended Use: "diagnostic ultrasound imaging and fluid flow analysis."
Indications for Use Equivalence: Same or subset of predicate device.	Subject Device Indications: Abdominal, Fetal/Obstetric, Gynecological, Fetal Echo, Musculo-skeletal (conventional), Urology, and Pediatric.Predicate Device Indications: Abdominal, Fetal, Gynecological, Urology, Pediatric, Fetal Echo, Intraoperative (non-neurological), Cephalic (adult), Musculo-skeletal (conventional), Peripheral vessel, Carotid, Procedural guidance of needles into the body. Performance: The subject device's indications are a subset of or match the predicate.
Technological Characteristics Equivalence: Similar fundamental technology, modes, and display/control mechanisms.	Fundamental Technology: "Track 3 system that adopt the same fundamental scientific technology as the predicate device 'Clarius Scanner (K192107)'."Portability: Both portable.Power Source: Both Li-Ion Battery.Wireless Communication: Subject: IEEE 802.11g/n; Predicate: IEEE 802.11g/n Bluetooth.Display/Control: Subject: Android mobile device; Predicate: Android or iOS mobile device.Modes of Operation: Subject: B-Mode, M-Mode, Color Doppler, Combined (B+M; B+CD). Predicate: B-Mode, M-Mode, Color Doppler, Power Doppler, PW Doppler, Combined (B+M; B+CD; B+PD, B+PWD). Performance: Similar, with the subject device offering a subset of the predicate's modes (e.g., no Power Doppler or PW Doppler listed for Apache).
Safety and Performance Standards Compliance: Meets relevant IEC, ISO, NEMA standards.	Non-Clinical Tests: "Nonclinical performance tests show compliance to the following standards:" - AAMI/ANSI ES60601-1 (Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance) - IEC 60601-1-2 (Electromagnetic Compatibility) - IEC 60601-1-6 (Usability) - IEC 60601-2-37 (Particular requirements for ultrasonic medical diagnostic and monitoring equipment) - IEC 62133 (Secondary Cells and Batteries Safety) - IEC 62366 (Application of Usability Engineering) - ISO 10993-1, -5, -10 (Biological Evaluation - Cytotoxicity, Irritation, Skin Sensitization) - IEC 62304 (Medical Device Software Life Cycle Processes) - ISO 14971 (Risk Management) - NEMA UD 2 (Acoustic Output Measurement Standard)Performance: The device has undergone non-clinical testing demonstrating compliance with these safety and performance standards.

Regarding Specific Diagnostic Performance Studies (AI/ML context):

The provided 510(k) summary is for a general-purpose diagnostic ultrasound system, not an AI/ML diagnostic algorithm. Therefore, many of your questions about diagnostic performance studies (sample size, experts, ground truth, MRMC, standalone performance, training sets) are not applicable to this document because such studies are not typically required for a 510(k) submission for a conventional ultrasound device, especially when claiming substantial equivalence and introducing "no new indications for use, modes, features, or technologies relative to the predicate devices (Clarius Scanner) that require clinical testing."

Here's an explicit breakdown of why these questions cannot be answered from the text:

Sample size used for the test set and the data provenance: Not applicable. No diagnostic performance test set described.
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 diagnostic performance test set described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No diagnostic performance test set 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: Not applicable. This is a conventional ultrasound system, not an AI-assisted diagnostic device described in this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a conventional ultrasound system, not an AI-enabled algorithm with standalone performance metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No diagnostic performance study for which ground truth would be established is mentioned.
The sample size for the training set: Not applicable. There is no mention of an AI/ML model that would require a training set.
How the ground truth for the training set was established: Not applicable. There is no mention of an AI/ML model that would require a training set.

Conclusion from the text:

The submission concludes: "The 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."

Summary

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November 12, 2020

Compal Electronics, Inc. % DK Lee Director of Product and Marketing No. 581, 581-1, Ruiguang Rd., Neihu Dist. Taipei City, 11492 TAIWAN

Re: K202074

Trade/Device Name: Apache Ultrasound System (Model C62) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 5, 2020 Received: October 7, 2020

Dear DK Lee:

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

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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 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 (OS) 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,

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) K202074

Device Name

Appache Ultrasound System (Model: C62)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K202074

510(k) Summary

Submitter:	Compal Electronics, Inc.
	Address: No. 581, 581-1, Ruiguang Rd., Neihu Dist.
	Taipei City, 11492, Taiwan(R.O.C.)
	Phone: +886-2- 87978599
Official Contact:	DK Lee
	Address: Rm. 140, Bldg. 52, No. 195, Sec. 4, Chunghsing Rd., Chutung, Hsinchu, 31057, Taiwan(R.O.C.)
Email	dk.lee@acosmartcare.com
Date Prepared:	October 5th, 2020
Device Name:	Apache Ultrasound System (Model: C62)
Regulation Number:	21 CFR 892.1550, 892.1560, 892.1570
Regulation Name	Ultrasonic Pulsed Doppler Imaging SystemUltrasonic Pulsed Echo Imaging SystemDiagnostic Ultrasonic Transducer
Regulatory Class	Class II
Product Code:	IYN, IYO, ITX
Intended Use	Diagnostic ultrasound imaging and fluid flow analysis
Indications for Use:	The Apache Ultrasound System (Model: C62) is intendedfor diagnostic ultrasound imaging and fluid flow analysisin the following applications: Abdominal, Fetal/Obstetric,Gynecological, Fetal Echo, Musculo-skeletal(conventional), Urology, and Pediatric. The systemprovides diagnostic ultrasound imaging in B, ColorDoppler, and M modes. The clinical environments wherethe system can be used include physician offices, clinics,hospitals, and clinical point-of-care for diagnosis ofpatients except environments where intensity ofelectromagnetic disturbances is high.The Apache Ultrasound System is a portable ultrasound

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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.

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).

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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 SystemModel: C62	Clarius Ultrasound System(K192107)Model: C3 HD
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	- Abdominal- Fetal- Gynecological- Urology- Pediatric- Fetal Echo	- Abdominal- Fetal- Gynecological- Urology- Pediatric- Fetal Echo- Intraoperative (non-neurological)- Cephalic (adult)- Musculo-skeletal(conventional)
		- Peripheral vessel
		- Carotid
		- Procedural guidance of needles into the body.
Portability	Portable Ultrasound System	Portable Ultrasound System
Power Source	Li-Ion Battery	Li-Ion Battery
Wireless Communication	Wireless communication via IEEE 802.11g/n	Wireless communication via IEEE 802.11g/n Bluetooth
Display and Control	Android mobile device	Android or iOS mobile device
Mode of operation	- B-Mode	- B-Mode
	- M-Mode	- M-Mode
	- Color Doppler	- Color Doppler
		- Power Doppler
		- PW Doppler
	- Combined (B+M; B+CD)	- Combined (B+M; B+CD; B+PD, B+PWD)

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Non-clinical test

Nonclinical performance tests show compliance to the following standards:

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

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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
NEMA UD 2	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment - Revision 3

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

The 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.