The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular

Device Description

The ZONCARE-M5 Ultrasound system consists of a main system along with associated transducers.

The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The ZONCARE-M5 system then analyzes the returned signal to generate an image or conduct Doppler processing.

The ZONCARE-M5 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

The system provides hardware buttons for the User Interface.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from Wuhan Zoncare Bio-medical Electronics Co., Ltd. for their "Full Digital Colour Doppler Ultrasonic Diagnostic System" (Model: ZONCARE-M5).

Based on the information provided in this document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

Crucially, this document does not describe a clinical study for proving the device meets acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, or human reader improvement with AI assistance).

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, the "Acclarix Diagnostic Ultrasound System" (K150999). The performance claims are primarily related to safety, electrical compatibility, acoustic output, and similar functional specifications, rather than a diagnostic accuracy study.

Here's a breakdown based on the categories requested, with explanations where information is not present:

A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence submission for an ultrasound system, the acceptance criteria are implicitly defined by compliance with recognized standards and similarity to the predicate device's cleared capabilities. There is no table of diagnostic performance metrics like accuracy, sensitivity, or specificity.

Implicit Acceptance Criteria & General Performance (based on comparison to predicate):

Acceptance Criteria Category	Description (Implicit)	Reported Device Performance
Intended Use	Diagnostic ultrasound imaging or fluid flow analysis of the human body for specified clinical applications.	Matches predicate: "Diagnostic ultrasound imaging or fluid flow analysis of the human body."
Clinical Applications	Ability to perform ultrasound evaluations for Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular.	Matches predicate's listed applications.
Imaging Modes	Ability to operate in B-Mode, M-Mode, PWD, CWD, Color Doppler, and Combined (B+M).	Matches predicate's listed modes (with "PDI/DPDI" instead of PDI for predicate).
Measurements	Perform standard measurements: B-Mode (Distance, Circ/Area, Angle, Volume, Stenosis), M-Mode (Distance, Time, Slope, Heart Rate), D-Mode (Velocity, RI, Time, PI, Heart Rate, Auto Trace PG, S/D, ΔV, Acceleration, PHT, VTI).	Matches predicate's listed measurements.
Safety Standards	Compliance with electrical safety, EMC, acoustic output, and biocompatibility standards.	Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, Acoustic output guidelines, ISO 10993-1, -5, -10.
Acoustic Output	Acoustic output within safe limits.	Matches predicate: Derated ISPTA: 720W/cm² maximum, Mechanical Index ≤1.9 maximum or Derated ISPPA 190 W/cm² max.
Device Configuration	Portable (laptop) Mobile Equipment.	Matches predicate.

Sample size used for the test set and the data provenance:

Not applicable in this document. The submission does not describe a clinical performance study using a test set of patient data to evaluate AI or diagnostic accuracy. The testing described is primarily non-clinical: electrical safety, EMC, acoustic output, and biocompatibility testing, which do not involve sample sizes of patient data.

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. As no clinical performance study involving a test set of patient data is described, there's no mention of experts establishing ground truth for diagnostic accuracy.

Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical performance study requiring adjudication of diagnostic findings is 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. This product is a "Full Digital Colour Doppler Ultrasonic Diagnostic System," which is a standalone imaging device, not an AI-assisted diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and was not performed.

If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an ultrasound imaging device, not an "algorithm only" software. Its performance is inherent in its hardware capabilities and image processing, not a separate AI algorithm that provides diagnostic findings independently.

The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for diagnostic accuracy. For the non-clinical tests (safety, EMC, acoustic output, biocompatibility), the "ground truth" is defined by the respective international standards and regulatory guidelines. For example, for biocompatibility, the ground truth is whether the materials meet ISO 10993 standards.

The sample size for the training set:

Not applicable. This document describes a traditional medical device (ultrasound system), not an AI/Machine Learning device that relies on a "training set" of data for learning or performance.

How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary:

The provided document, a 510(k) Premarket Notification, is for a conventional ultrasound imaging system. The "study" proving the device meets acceptance criteria is a series of non-clinical tests and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. It does not involve AI or diagnostic accuracy studies on patient data, which is common for standalone imaging hardware. The acceptance criteria are primarily related to safety, electromagnetic compatibility, acoustic output, biocompatibility, and functional equivalence to the predicate device.

Summary

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Wuhan Zoncare Bio-medical Electronics Co., Ltd. % Long Yang, COO Shenzhen Hlongmed Biotech Co., Ltd. 1002, 10th Floor, Zhongxing Administrative Building Zhongxing Industrial Zone, Chuangye Road, Nanshan Shenzhen, Guangdong 518054 CHINA

July 10, 2019

Re: K183041

Trade/Device Name: Full Digital Colour Doppler Ultrasonic Diagnostic 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 31, 2019 Received: June 5, 2019

Dear Long Yang:

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); 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 medical devices and radiation-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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Section 10

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K183041

Device Name

Full Digital Colour Doppler Ultrasound Diagnostic System

Indications for Use (Describe)

The ZONCARE-M5 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:

Abdominal Gynecology(including endovaginal) Obstetric Cardiac Small parts(Breast,Testes,Thyroid,etc.) Urology Musculoskeletal Peripheral vascular

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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