The NEMIO systems are intended to be used for the following type of studies; fetal, abdominal, intraoperative, pediatric, small organs, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, transesophageal, peripheral vascular, musculo-skeletal (both conventional and superficial), and laparoscopic.

Device Description

The NEMIO will be offered in three variations all of which are mobile systems. These systems are all Track 3 devices that employ a wide array of probes that include flat linear array, convex linear array, and sector array with a frequency range of approximately 2 MHz to 12 MHz. The differences in systems will be the availability of various options such as size of monitor, ultrasonic, modes, and post processing display capabilities.

AI/ML Overview

The provided text is a 510(k) Summary for a diagnostic ultrasound imaging system (NEMIO, SSA-550A) and a related transducer. It outlines regulatory information, intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the context of proving the device meets specific performance criteria.

The "Acceptance Criteria" mentioned in the document relate to general regulatory compliance and manufacturing standards, not specific performance metrics of the ultrasound's diagnostic capabilities. The safety considerations listed (IEC standards, AIUM-NEMA standards) are about the design and manufacturing of the device, and acoustic output measurements are a post-clearance requirement, not pre-market performance validation in the sense of a clinical study.

Therefore, for almost all the requested information, the answer is that the document does not provide it.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
No specific performance acceptance criteria are mentioned in the document. The "Safety Considerations" section refers to compliance with design and manufacturing standards: - Quality System Regulation - IEC 60601-1 - IEC 60601-1-2(2001) - IEC 60601-2-37(2001) - IEC 60601-2-37 Amd. 1(2004) - AIUM-NEMA UD2 Output Measurement Standard - AIUM-NEMA UD3 Output Display Standard	No specific device performance metrics are reported in the document. The document focuses on regulatory compliance and substantial equivalence to predicate devices (Toshiba NEMIO SSA-550A Diagnostic Ultrasound System, K010631; Siemens G60 Diagnostic Ultrasound System, K040060). It also indicates that acoustic output measurements based on production line devices are a post-clearance requirement.

Acceptance Criteria

Reported Device Performance

No specific performance acceptance criteria are mentioned in the document. The "Safety Considerations" section refers to compliance with design and manufacturing standards: - Quality System Regulation - IEC 60601-1 - IEC 60601-1-2(2001) - IEC 60601-2-37(2001) - IEC 60601-2-37 Amd. 1(2004) - AIUM-NEMA UD2 Output Measurement Standard - AIUM-NEMA UD3 Output Display Standard

No specific device performance metrics are reported in the document. The document focuses on regulatory compliance and substantial equivalence to predicate devices (Toshiba NEMIO SSA-550A Diagnostic Ultrasound System, K010631; Siemens G60 Diagnostic Ultrasound System, K040060). It also indicates that acoustic output measurements based on production line devices are a post-clearance requirement.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not provided. This document is a regulatory submission for substantial equivalence based on technical specifications and comparison to predicate devices, not a clinical performance study.
Data Provenance: Not provided.

3. 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)

Number of Experts: Not provided.
Qualifications of Experts: Not provided.

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

Adjudication Method: Not applicable/Not provided. The document does not describe a test set or a process requiring adjudication for performance evaluation.

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

MRMC Comparative Effectiveness Study: No. This document is for an ultrasound system, not an AI-assisted diagnostic tool. No such study is mentioned.
Effect size of AI assistance: Not applicable/Not provided.

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

Standalone Performance Study: Not applicable/Not provided. This document describes an ultrasound system, which inherently involves human operation and interpretation. It is not an algorithm for standalone diagnosis.

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

Type of Ground Truth: Not applicable/Not provided. The document does not detail any studies requiring the establishment of ground truth for diagnostic performance assessment.

8. The sample size for the training set

Sample Size (Training Set): Not applicable/Not provided. The document does not describe any machine learning or algorithm training.

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

Ground Truth Establishment (Training Set): Not applicable/Not provided. The document does not describe any machine learning or algorithm training.

Summary

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NOV 1 7 2004

KON3078

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

Submitter's Name:	Toshiba America Medical Systems, Inc.
Address:	P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068
Contact:	Paul Biggins, Senior Manager Regulatory Affairs
Telephone No.:	(714) 730-5000
Device Proprietary Name:	NEMIO, SSA-550A
Common Name:	Ultrasound Imaging 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 the Following devices:

1. Toshiba NEMIO SSA-550A Diagnostic Ultrasound System, 510(k) control number K010631
1. Siemens G60 Diagnostic Ultrasound System, 510(k) control number K040060

Device Description:

Intended Use:

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Safety Considerations:

These devices are designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1, IEC 60601-1-2(2001), IEC 60601-2-37(2001), IEC 60601-2-37 Amd. 1(2004) and the AIUM-NEMA UD2 Output Measurement Standard as applied to the Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. 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

NOV 17 2004

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 2441 Michelle Drive TUSTIN CA 92780

Re: K043078

Trade Name: NEMIO Diagnostic Ultrasound System, Model SSA-550A Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: November 3, 2004 Received: November 8, 2004

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 NEMIO Diagnostic Ultrasound System, Model SSA-550A, as described in your premarket notification:

Transducer Model Number

PVM-375MV

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If your 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 ican 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 r hat 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" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 - Mr. Job

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

Sincerely yours,

David H. Lyman

for

September 19. 1.

. . . . . .

Production of the

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

・

: .

. ,

. . .

. :

. .

Enclosure(s)

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Diagnostic Ultrasound Indications For Use Form

Transducer___ System X_ Model____NEMIO; SSA-550A 510(k) Number(s) _____________________________________________________________________________________________________________________________________________________________

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	HarmonicImaging
Ophthalmic							P	P	P	P
Fetal		P	P	P	P	P		P	P	P
Abdominal		P	P	P	P	P	P	P	P
Intraoperative (small organs)		P	P	P		P	P
Intraoperative Neurological									P	P
Pediatric		P	P	P	P	P	P	P	P	P
Small Organ (Specify)		P	P	P		P	P	P		P
Neonatal Cephalic		P	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	P
Transesophageal		P	P	P	P	P	P	P	P	P
Transrectal		P	P	P		P	P	P	P
Transvaginal		P	P	P		P	P	P	P	P
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P	P	P	P
Laparoscopic		P	P	P		P	P	P	P	P
Musculo-skeletal Superficial		P	P	P		P	P	P	P	P
Musculo-skeletal		P	P	P		P	P	P	P	P
Conventional
Endoscopic
Other (specify)

Other (specif) / P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments: ________________________________________________________________________________________________________________________________________________________ TDI; M-TDI

Previous 510(k) control Number: K010361

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

દિવસ્તિ ભારત છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા

and Radiological Devices

510(k) Number _

Prescription Use (Per 2) Diffigion Division of Reproductive, Abdom

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NEW TRANSDUCER TABLE

Trunsducer Model Number: PVM-375MV SI(X) Control Number:

			Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (Specify)	Harmonic Imaging
Ophthalmic
Fetal		N	N	N		N	N	N	N	N
Abdominal		N	N	N		N	N	N	N	N
Intraoperative
Intraoperative
Neurological		N	N	N		N	N	N	N	N
Pediatric		N	N	N		N	N	N	N	N
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
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)

-- Combined Modes: B/M: B/PWD: BDF/PWD; BDF/MDF; B= Additional Comments: _ TDI M-TDI

This is x new mansducer but all indications have been previously cleared on existing

transducers.

(CCASE DO NOT WELTE BELOW THIS LINE - CONTINUE OR OTHER FACES IS H22020) urrence of CDRH. Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801 109)

David A. Legmann

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

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.