This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.

AI/ML Overview

This device is a Diagnostic Ultrasound System called APLIO ARTIDA MODEL SSH-880CV. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study that proves each criterion.

Therefore, the information regarding specific acceptance criteria and a study proving device performance in the format requested cannot be fully extracted from this document. This type of document typically references compliance with general industry standards and regulations, and lists intended uses and transducers, but does not usually include a dedicated performance study with acceptance criteria in the manner requested for AI/algorithm-based devices.

However, based on the information provided, here's what can be gathered, with limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or device performance metrics like sensitivity, specificity, or AUC as one would find for an AI-enabled diagnostic device. Instead, it demonstrates compliance through substantial equivalence to predicate devices and adherence to relevant industry standards.

Acceptance Criteria	Reported Device Performance (as implied by predicate equivalence & standards)
Safety: Device compliance with safety standards	Designed and manufactured in conjunction with Quality System Regulation, IEC 60601-1, IEC 60601-1-2, IEC60601-2-37, and AIUM-NEMA UD2/UD3 Output Measurement & Display Standards.
Effectiveness/Performance: Substantial equivalence to legally marketed predicate devices for intended uses.	Determined substantially equivalent to: 1) Toshiba Ultrasound Diagnostic System APLIO ARTIDA MODEL SSH-880A (K072826) 2) Toshiba Ultrasound Diagnostic System APLIO XG MODEL SSA-790A (K072000) for cardiac, transesophageal, and peripheral vascular studies.
Acoustic Output: Within approved levels	A post-clearance special report containing complete information, including acoustic output measurements based on production line devices, is required. (This implies an ongoing acceptance criterion, not a pre-market performance metric for AI).

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

This information is not provided in a 510(k) summary for a diagnostic ultrasound system. Clinical test sets, data provenance, and sample sizes are typically associated with performance studies for devices with novel clinical claims, especially AI/ML devices, which is not the primary focus of this submission. The determination of substantial equivalence relies on comparison to predicate devices, not on a new clinical study with a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. As explained above, this 510(k) relies on substantial equivalence to predicate devices and not on a de novo clinical study with a ground truth established by experts.

4. Adjudication method for the test set:

This information is not provided.

5. 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:

This is explicitly not an AI-enabled device. This document describes a traditional diagnostic ultrasound system. Therefore, no MRMC comparative effectiveness study involving AI or assessing improvement of human readers with AI assistance was performed or would be relevant for this submission.

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

This is not an AI/algorithm-only device. It is a diagnostic ultrasound system. Therefore, a standalone algorithm performance study was not done.

7. The type of ground truth used:

Not applicable in the context of this 510(k) summary, as it relies on substantial equivalence rather than a new clinical performance study requiring ground truth.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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Toshiba America Medical Systems, Inc

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

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

Device Proprietary Name:	APLIO ARTIDA MODEL SSH-880CV
Common Name:	Diagnostic Ultrasound System

Classification:

Regulatory Class: II Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed.Reg.No .: 892.1550] Ultrasonic Pulsed Echo Imaging System -- Product Code: 90-IYO [Fed.Reg.No .: 892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed. Reg. No.: 892.1570]

Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

1. Toshiba Ultrasound Diagnostic System APLIO ARTIDA MODEL SSH-880A ; 510(k) control number K072826.
1. Toshiba Ultrasound Diagnostic System APLIO XG MODEL SSA-790A ; 510(k) control number K072000.

Device Description:

This device is a mobile system is a Track 3 device that employs a wide range of probes that include flat linear array and sector array with a frequency range of approximately 2.5 MHz to 7.5 MHz.

Intended Use:

This device is intended to be used for the following type of studies; cardiac, transesophageal and peripheral vascular.

Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 8 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K080160

Trade/Device Name: APLIO ARTIDA Model: SSH-880CV Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 22, 2008 Received: January 23, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket 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 APLIO ARTIDA Model: SSH-880CV Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PST-25SX
PST-30SBT
PLT-704SBT
PET-511BTM
PC-20M

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If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Vou M. Whay

Nancy C. Brogdon दि Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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System _X Transducer Model SSH-880CV 510(k) Number(s) 000000

ClinicalApplication	B	THI	M	ColorDoppler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)*	4D(Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative(Specify)
IntraoperativeNeurological
Pediatric									N
Small Organ(Specify)	N	N	N	N	N	N		N				N
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N			N	N	N	N	N	N	N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	N	N	N	N	N	N		N	N			N
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF;

BDF/MDF/PWD; 2D/CWD; BDF/CWD

Small organ = heart Cardiac = adult and pediatric

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

V Prescription Use (Per 21 CFR 801.109)11

lori McWhay

(Divišion Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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Toshiba America Medical Systems, Inc

Diagnostic Ultrasound Indications For Use Form

System	Transducer X
Model	PST-25SX
510(k) Number(s)	K080160

	Mode of Operation
Clinical Application	B	THI	M	ColorDopp-ler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)	4D(Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P											P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Additional Comments: Combined Modes: None

Predicate 510(k) K072826

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

Prescription Use (Per 21 CFR 801.109)

Larry M. Why
(Division Sign Off)

Division of Reproductive, Abdominal and Radiologica 510(k) Number

A-6

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Transducer X System PST-30SBT Model 510(k) Number(s) X0100

・)

	Mode of Operation
Clinical Application	B	THI	M	ColorDopp-ler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)	4D(Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P			P	P	P	P	P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/C

Previous 510k of this transducer : K072826

(please do not write below this line - continue on other pages fr ni Concurrence of CDRH, Office of Device Evaluation (9

/ Prescription Use (Per 21 CFR 801.109)

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

Division of Reproductive, Abdomi
Radiological Devices
510(k) Number K08

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System Transducer X Model PLT-704SBT 510(k) Number(s)

KOSOKOO

	Mode of Operation
Clinical Application	B	THI	M	Color Doppler	Power	Dynamic Flow	TDI	PW	CW	CHI 2D	CHI Dynamic Flow	Combined (Specify)*	4D (Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative Neurological
Pediatric
Small Organ (Specify)	P	P	P	P	P	P		P				P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P		P				P
Laparoscopic
Musculo-skeletal Superficial
Musculo-skeletal Conventional

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

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

Additional Comments: Combined Modes: B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD;

Previous 510(k) of this transducer: K072000

(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)11

Lori M. Whay
Division Sign-Off

Division of Reproductive. Abdominal a 510(k) Numbe

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Toshiba America Medical Systems, Inc

510(k) Premarket Notification Aplio Artida SSH-880CV Ultrasound System

Diagnostic Ultrasound Indications For Use Form

System Transducer X PET-511BTM Model 510(k) Number(s) 080160

	Mode of Operation
Clinical Application	B	THI	M	ColorDopp-ler	Power	DynamicFlow	TDI	PW	CW	CHI2D	CHIDynamicFlow	Combined(Specify)	4D(Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
IntraoperativeNeurological
Pediatric
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal	P	P	P	P				P	P	P		P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalSuperficial
Musculo-skeletalConventional

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

Combined Modes: B/M; B/PWD; Additional Comments: BDF/PWD; BDF/MDF; BDF/MDF/PWD;B-TDI; M-TDI; 2D/CWD; BDF/CWD;

Previous 510k of this transducer : K072000

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

Evaluation (GDE)

(Division Sign-Off)

Division Sign-Off) (Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

A-9

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Transducer X System PC-20M Model 510(k) Number(s)

	Mode of Operation
Clinical Application	B	THI	M	ColorDopp-ler	Power	DynamicFlow	TDI	PW	CW	CHI2D	ેનાDynamicFlow	Combined(Specify)	4D(Realtime 3D)
Ophthalmic
Fetal
Abdominal
Intraoperative (Specify)
Intraoperative
Neurological
Pediatric									P
Small Organ (Specify)*
Neonatal Cephalic
Adult Cephalic
Cardiac									P
Transesophageal
Transrectal
Transvaginal
Transurethrai
Intravascular
Peripheral Vascular									P
Laparoscopic
Musculo-skeletal
Superficial
Musculo-skeletal
Conventional

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

Additional Comments:

Previous 510k of this transducer : K072000

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

v Prescription Use (Per 21 CFR 801.109)

Lori M. Whay

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

A-10

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.