Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.

Scientific Concept: Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes.

Description of Modification: The modification includes the addition of several new/modified circuit boards and modifications to the software to allow two existing transducers to operate in this manner.

Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography. The modification is to provide and existing device with the capability of receiving echoes at a frequency different than the transmitted frequency.

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba PowerVision 7000 Ultrasound Imaging System with a modification for Harmonic Imaging and Flash Echo Imaging Function. This document does not describe a study to prove the device meets acceptance criteria in the manner typically expected for AI/ML-driven medical devices.

Instead, this submission is for a modification to an existing ultrasound system, and the acceptance criteria and supporting information are framed within the context of demonstrating substantial equivalence to predicate devices and ensuring the safety and effectiveness of the modified functionality.

Therefore, many of the requested categories (e.g., sample size for test/training set, ground truth experts, MRMC study, standalone performance) are not applicable or explicitly mentioned in this type of submission for a hardware/software modification to an ultrasound system. The focus is on the technical description of the modification and its impact on performance parameters such as acoustic output and image quality.

However, I can extract the relevant information based on the document's content:

Acceptance Criteria and Reported Device Performance

The provided document does not contain an explicit table of acceptance criteria with numerical targets and corresponding reported performance metrics in the way one might typically expect for an AI/ML device. Instead, the "acceptance criteria" can be inferred as demonstrating that the modified device remains safe and effective for its intended use and is substantially equivalent to predicate devices. The performance is reported in terms of functionality and anticipated image quality improvement.

Acceptance Criteria Category	Description from Document	Reported Device Performance/Claims
Functional Equivalence/Improvements	The modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency. This modification equips the SSA-380A to detect and process those harmonic echoes. This enables "Tissue Harmonics" (n - new indication) and "Harmonics w/Contrast" (n - new indication) functionality for various clinical applications, and "FEI" (Flash Echo Imaging) for Cardiac applications.	The device, as modified, is capable of Harmonic Imaging and Flash Echo Imaging. The FDA granted substantial equivalence on the condition of a post-clearance special report on acoustic output measurements based on production units. This implies the device is expected to perform as described in terms of its new imaging modes.
Safety - Acoustic Output	"Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography."	The modification does not change the amount of acoustic output required in conventional ultrasonography. A post-clearance special report is required to provide "complete information, including acoustic output measurements based on production line devices" and that values must not be "greater than approved levels."
Intended Use	"Intended use remains unchanged from the SSA-380A." However, the "Indications For Use Form" introduces "new" (n) indications for "Tissue Harmonics," "Harmonics w/Contrast," and "FEI" for specific transducers and applications.	The device is deemed substantially equivalent for the indications for use stated in the enclosure which now includes the new harmonic imaging functionalities for the specified transducers and clinical applications.
Substantial Equivalence to Predicate Devices	The device is substantially equivalent to four predicate devices: HP Sonos 2500, ATL Level 10 HDI, Diasonics/Vingmed System 5, and Toshiba SSA-380A PowerVision. (This is the overarching "acceptance criteria" for a 510(k) submission, proving that the device is as safe and effective as a legally marketed device). The scientific concept for the modification is "Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes."	The FDA determined "the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "reported performance" against the primary acceptance criterion, based on the provided technical description and the manufacturer's claims.

Study Information

For this type of 510(k) submission (a modification to an ultrasound system adding new imaging modes), a clinical study with a "test set" in the context of AI/ML performance evaluation (e.g., sensitivity, specificity for a diagnostic task) is not described. The "study" here refers to the technical evaluation and demonstration of substantial equivalence.

Sample size used for the test set and the data provenance: Not applicable in the context of a conventional "test set" for an AI/ML algorithm's diagnostic performance. The evaluation is based on technical specifications and demonstration of system capabilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would generally refer to established scientific principles of ultrasound physics and engineering standards for device performance, rather than expert clinical annotation of images for a specific diagnostic task.
Adjudication method for the test set: Not applicable.
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: An MRMC comparative effectiveness study was not done or described. This submission predates the widespread regulatory focus on AI/ML in medical devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm in the modern sense but a hardware/software modification to an imaging system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly relies on established physics of ultrasound, engineering principles, and the safety and effectiveness track record of the predicate devices. For acoustic output, it would be based on validated measurement techniques and established safety limits.
The sample size for the training set: Not applicable. This is not an AI/ML system that undergoes a "training" phase with data.
How the ground truth for the training set was established: Not applicable.

Summary

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JUL 31 1000

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

KQ81397

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068
Contact:	Paul Biggins, Regulatory Affairs Specialist
Telephone No .:	(714) 730-5000

Device Proprietary Name: PowerVision 7000 Ultrasound Imaging System Common Name:

Classification:

Regulatory Class: П Tier II Review Category: Ultrasonic Pulsed Doppler Imaging System Accessory [Fed.Reg.No .: 892.1550.Pro.Code:90-IYN]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that the SSA-380A PowerVision 7000 is substantially equivalent to:

1. HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997
1. ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997
1. Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997
1. Toshiba SSA-380A PowerVision 510(k)s K933473 & K943303

Device Description:

Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.

Statement of Intended Use:

Intended use remains unchanged from the SSA-380A.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

JUL 31

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul Bigggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. P.O. Box 2068 2441 Michelle Drive Tustin, CA 92781-2068

Re: K981397 Trade Name: Harmonic Imaging and Flash Echo Imaging Function for the SSA-380A Diagnostic Ultrasound System (PowerVision 7000) Regulatory Class: II/21 CFR 892.1550/21 CFR 892.1570 90 IYN/90 ITX Product Code: Dated: July 1, 1998 Received: July 2, 1998

Dear Mr. Biggins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the SSA-380A Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PSK - 25AT PVT - 357AT

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Paul Biggins

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers (Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Diagnostic Ultrasound Indications For Use Form

System X Transducer____________________________________________________________________________________________________________________________________________________________________ Model SSA-380A 510(k) Number(s) _K933743, K943303, K964865, K970047

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	TissueHarmonics	Harmonicsw/Contrast	FEI
Ophthalmic
Fetal	p	p	p	p	p	p	p	p	*	n
Abdominal	p	p	p	p	p	p	p	p	*	n
Intraoperative (Abdominal)	e	e	e	e	e	e	e	e	*
Intraoperative Neurological
Pediatric	p	p	p	p	p	p	p	p	*	n
Small Organ	p	p	p	p	p	p	p	p	*
-Breast
-Testicle
-Thyroid
Neonatal Cephalic	p	p	p	p	p	p	p	p	*
Adult Cephalic	p	p	p	p	p	p	p	p	*
Cardiac	p	p	p	p	p	p	p	p	*	n	n	n
Transesophageal	p	p	p	p	p	p	p	p	*
Transrectal	p	p	p	p	p	p	p	p	*
Transvaginal	p	p	p	p	p	p	p	p	*
Transurethral	p	p	p	p	p	p	p	p	*
Intravascular
Peripheral Vascular	p	p	p	p	p	p	p	p	*	n
Laparoscopic
Musculo-skeletal Superficial	p	p	p	p	p	p	p	p	*
Musculo-skeletal Conventional	p	p	p	p	p	p	p	p	*
Other (specify)

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDJ,M-TDI

The SSA-380A is ready for use with Contrast Agents for their approved uses.

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Wilkan you

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

Radiological Devices
510(k) Number K981397

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

Diagnostic Ultrasound Indications For Use Form

System _____ Transducer 区 Model PSK-25AT 510(k) Number(s) K933743

	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	TissueHarmonics	Harmonicsw/Contrast	FEI
Clinical Application
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organ
-Breast
-Testicle
-Thyroid
Neonatal Cephalic
Adult Cephalic
Cardiac	p	p	p	p	p	p	p	p	*	n	n	n
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal Conventional
Other (specify)

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combinations BM, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI

The PSK-25AT is ready for use with Contrast Agents for their approved uses.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

W.Carlyn

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number K981397

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

Diagnostic Ultrasound Indications For Use Form

System Transducer_X Model PVK-357AT 510(k) Number(s) K943303

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	TissueHarmonics
Ophthalmic
Fetal	p	p	p	p	p	p	p	*	n
Abdominal	p	p	p	p	p	p	p	*	n
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	p	p	p	p	p	p	p	*	n
Small Organ	p	p	p	p	p	p	p	*
-Breast
-Testicle
-Thyroid
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	p	p	p	p	p	p	p	*	n
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal Conventional
Other (specify)

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI

The PVK-357AT is ready for use with Contrast Agents for their approved uses.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON OTHER PAGES IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)

and Radiological Dev

510(k) Number

Division of Reproductive, Abdominal, ENT,

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.