TE7/TE5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

Device Description

TE7/TE5 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO, Color M, Smart 3D, TDI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).. This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 3.0 MHz to 13.5 MHz.

AI/ML Overview

This document describes a 510(k) premarket notification for the TE7 and TE5 Diagnostic Ultrasound Systems. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving a new level of performance through extensive clinical studies. Therefore, many of the typical elements of an AI/ML device study (like MRMC studies, specific ground truth methods for image interpretation, and detailed performance metrics beyond equivalence) are not present in this type of submission.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The device performance is generally presented by stating its comparability to the predicate in key features and functions.

The document lists various modes of operation and clinical applications for which the TE7/TE5 Diagnostic Ultrasound System is intended. The "P" in the tables indicates that an indication/mode was previously cleared by FDA K143472 (a predicate device). "N" indicates a new indication/mode for the current submission that is being demonstrated as substantially equivalent to other predicates (M9 K152543, Resona 7 K152763, M7 K131690).

Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for an ultrasound system, the acceptance criteria are not typically phrased as specific performance metrics like sensitivity/specificity for an AI algorithm. Instead, they relate to meeting safety and performance standards comparable to predicate devices. The "performance" is implicitly deemed equivalent if the device meets these standards and functions as intended for the specified applications.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the document)
Same Intended Uses as predicate devices	TE7/TE5 Diagnostic Ultrasound System has the "same intended uses and basic operating modes" as predicate TE7 (K160381).
Similar Technological Characteristics as predicate devices	TE7/TE5 has "the same technological characteristics" as predicate TE7 (K160381).
Comparable Key Safety & Effectiveness Features	TE7/TE5 is "comparable in key safety and effectiveness features" to predicate TE7 (K160381).
Below FDA Acoustic Output Limits	"It has the system acoustic power level which is below FDA limits."
Compliance with FDA Recognized Standards	"It is designed in compliance with same FDA recognized standards." (Numerous standards listed including IEC 60601 series, ISO 14971, ISO 10993-1, IEC 62304).
Comparable Measurement & Calculation Functions	TE7/TE5 has the "same capability in terms of measurements and calculation functions except adding calculation IVC. New added calculation is substantial equivalent with the its predicates TE7 (K160381)."
Similar Performance Specification	TE7/TE5 has the "same performance specification as the predicate device except adding TDI, Smart 3D, Color M and IMT which is substantial equivalent with predicate M7(K131690)."
Biocompatibility for modified probes	"The modification on the probe L12-4s, L14-6Ns and C5-2s has been tested under ISO 10993-1."
Cleaning and Disinfection Effectiveness	"has been evaluated for cleaning and disinfection effectiveness."
Thermal, Electrical, and Mechanical Safety	"has been evaluated for thermal, electrical and mechanical safety."

Study Details (based on the provided text):

Sample sizes used for the test set and the data provenance:
- The document explicitly states "Clinical Studies: Not applicable." and "The subject of this submission, TE7/TE5 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."
- This implies that no specific "test set" of clinical cases (e.g., patient images interpreted by the device) was used for performance evaluation in the way an AI/ML device would be. Instead, the testing relies on non-clinical tests (acoustic output, biocompatibility, safety standards, etc.) and comparisons to previously cleared predicate devices.
- Therefore, there is no sample size for an clinical test set and no provenance information for such data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- As no clinical studies were performed, there was no test set with ground truth established by experts for device performance evaluation in the context of diagnostic accuracy.
- The "ground truth" for demonstrating substantial equivalence here would be the validated performance and safety of the predicate devices, and the established industry standards the new device conforms to.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set was used for diagnostic performance evaluation or expert review.
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 MRMC study was done. The device is an ultrasound system, not an AI-assisted diagnostic tool that aids human readers in image interpretation for specific findings. The submission is for the imaging system itself.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not distinctly applicable in the context of an ultrasound system. The "algorithm" here refers to the core image acquisition and processing capabilities of the ultrasound machine and its transducers. The performance of these functionalities is assessed through engineering tests and compliance with recognized standards, not as a standalone AI algorithm interpreting images.
The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is primarily based on engineering and performance standards conformity (e.g., acoustic output limits, electrical safety, biocompatibility, etc.) and the established performance and safety profiles of the predicate devices that the new device claims substantial equivalence to. There is no mention of clinical ground truth (like pathology or outcomes) being used to evaluate the diagnostic accuracy of the device itself in this submission.
The sample size for the training set:
- Not applicable as this is not an AI/ML device that requires a "training set" in the context of machine learning model development. The development of an ultrasound system involves design, engineering, and testing processes, not a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable for the same reasons as #7.

Summary

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July 13, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Ms. Wu Zicui Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 P. R. CHINA

Re: K161525

Trade/Device Name: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 10, 2016 Received: June 2, 2016

Dear Ms. Zicui:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161525 Device Name

TE7 Diagnostic Ultrasound System, TE5 Diagnostic Ultrasound System

Indications for Use (Describe)

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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