The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.

The device is not indicated for Ophthalmic applications.

Device Description

Linear Array transducer

AI/ML Overview

The provided text describes a 510(k) premarket notification for diagnostic ultrasound transducers (Hitachi Aloka Medical, Ltd. UST-5310 and UST-5311). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to prove novel performance benefits.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as would be common for AI/ML-based diagnostic devices. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to existing predicate devices.

The "performance" of the device is assessed by its technical comparability and safety.

Acceptance Criteria Category	Reported Device Performance (Summary from 510(k))
Substantial Equivalence to Predicate Device	The UST-5310 and UST-5311 are technically comparable and substantially equivalent to the currently marketed UST-534 & UST-536 Intraoperative transducers. Both are track 3 systems with the same fundamental and scientific technologies.
Safety	- Evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical, and mechanical safety. - Found to conform to applicable medical device safety standards. - Biocompatibility testing conducted in accordance with ISO 10993-1. - Acoustic level below Track 3 FDA limits.
Manufacturing	Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
Technology	Same essential technology for imaging, Doppler functions, and signal processing as predicate devices.
Modes of Operation	Same modes of operation (B, M, PWD, CD, PowerFlow, and combinations).
Intended Use/Indications	Indicated for diagnostic ultrasound imaging during Intra-operative and Intra-operative (neurosurgery) procedures, similar to predicate but with a difference in sterilization methodology (single-use sterile vs. reusable).
Sterilization	Designed to be sterilized via EtO. The subject device is supplied sterile, while the predicate is supplied non-sterile with instructions for cleaning, disinfection, and sterilization.
Materials	New material: Ethylene Vinyl Acetate, but all other materials previously cleared by FDA.

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

No clinical test set or data provenance is mentioned. The submission explicitly states "Clinical testing: None required." This indicates that the regulatory pathway for these transducers did not require a clinical study with a test set of patient data, as the device is deemed substantially equivalent based on technical specifications and non-clinical testing.

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

Not applicable, as no clinical testing with a test set was required or performed for this submission.

4. Adjudication method for the test set

Not applicable, as no clinical testing with a test set was required or performed.

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

Not applicable. This device is a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware component (ultrasound transducer), not a standalone algorithm.

7. The type of ground truth used

Not applicable in the context of clinical performance. The "ground truth" for this submission revolves around technical and safety standards compliance and substantial equivalence to a legally marketed predicate device. This is demonstrated through non-clinical testing (acoustic output, biocompatibility, electrical safety, etc.) as opposed to clinical outcomes or expert consensus on image interpretation.

8. The sample size for the training set

Not applicable. This is a hardware device (ultrasound transducer), not an AI/ML system requiring a training set.

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

Not applicable. No training set or associated ground truth establishment is mentioned or relevant for this type of device.

Summary

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Hitachi Aloka Medical, Ltd.

K140854
Page 1 of 2

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

JUN 1 1 2014

21 CFR 807.92, Subscction a

Submitter's Information

Hitachi Aloka Medical. Ltd. 10 Fairfield Boulevard Wallingford. CT 06492-5903

Contact: Angela Van Arsdale RA/QA Manager

Telephone: (203) 269-5088 Ext: 346 Fax Number: (203) 269-6075

Date Prepared: April 1, 2014

Device / Common / Classification Name / Classification / Product Code:

Device Proprietary Name - UST-5310 and UST-5311 Common name - Diagnostic Ultrasound Transducer Classification name - Diagnostic Ultrasonic Transducer Classification: Class II Product Code: 90-1TX 892.1570 Diagnostic Ultrasonic Transducer

Legally Marketed Predicate Device(s):

UST-533 Intraoperative Ultrasound Transducer [K122537] UST-534 Intraoperative Ultrasound Transducer [K122537] UST-536 Intraoperative Ultrasound Transducer [K122537]

1. Device Description:
  Linear Array transducer

Indication for Use:

Sterile single-use Intra-Operative Linear transducer for use in conjunction with ProSound Alpha 6 [K093488]

Comparison to predicate device:

The Hitachi Aloka Medical, I.td. UST-5310 and UST-5311 Intraoperative transducers are technically comparable and substantially equivalent to the currently marketed UST-534 & UST-536 Intraoperative transducers. The subject and predicate systems are track 3 systems that incorporate the same fundamental and scientific technologies. The follows compares the subject and predicate devices:

Subject devices:	Predicate devices:
Single-use sterile device - sterilized via EtO	Reusable device - Sterilized via EtO
New material: Ethylene Vinyl Acetate	All materials previously cleared by FDA
Intraoperative linear array	Intraoperative linear array
Modes of operation: B, M, PWD, CD, PowerFlow and	Modes of operation: B, M, PWD, CD, PowerFlow and
Combination of each operating mode	Combination of each operating mode

510(K) Premarket Notification - Sterile Transducers

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Page 2 of 2

21 CFR Part 807.92, Section b

1. Non-clinical Testing
  No new hazards were identified with the addition of the added indications and software features. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.

2. Clinical testing:

None required

3. Conclusions:

The Hitachi Aloka Medical. Ltd. Sterile Transducer is substantially equivalent in salety and effectiveness to the predicate device:

. The subject and predicate device(s) are both indicated for diagnostic ultrasound imaging.
The subject and predicate device(s) have the same grav scale and Doppler capabilities. .
The subject and predicate device(s) have the same essential technology for imaging, Doppler functions, and signal processing.
. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits.
. The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations.
. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards.
. The subiect and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1: all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile.
l The subject and predicate device(s) are designed to be sterilized via EtO, the only difference is that the subject device is supplied sterile and the predicate is supplied non-sterile with instructions for cleaning. disinfection, and sterilization in the transducer manuals.

END OF SUMMARY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. The logo is black and white and appears to be of low resolution.

Public Health Service

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

June 11, 2014

Hitachi Aloka Medical, Ltd. % Ms. Angela Van Arsdale Regulatory Affairs/Quality Assurance Manager 10 Fairfield Blvd. WALLINGFORD CT 06492

Re: K140854

Trade/Device Name: UST-5310 and UST-5311 Intra-operative Ultrasound Transducers Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: May 30, 2014 Received: June 2, 2014

Dear Ms. Van Arsdale:

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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Page 2-Ms. Van Arsdale

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,

for

Janine M. Morris 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) K140854

Device Name UST-5310 / UST-531 !

Indications for Use (Describe)

The device is not indicated for Ophthalmic applications.

Type of Use (Select one or both. as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send commonts regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@lda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DIAGNOSTICULTRASOUNDINDICATIONS FOR USE FORM

Device Name: Hitachi ProSound Alpha 6 K093488 Transducer: UST-5310 Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Specify)	Other**(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify)*	E	E	E		E	1:	1:
	Intra-operative (Neurosurgery)	E	E	1.		E	F	E
	Laparoscopic**
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify) *
	Other: Gynecological
	Cardiac Adult
Cardiac	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral	Peripheral Vascular
Vessel	Other (spec.)

N * new indication. P = previously cleared by FDA: E = added under Appendix 1 - Specifications

Combination of each operating mode includes:

Combination of each operating mode- BRA, BIPWD, MICD, BICD/PWD, B/CD/CWD * 2 Includes: M10w, B/Bfow, Power Row.

Intra-operative (Specify)® - (liver, pancreas, gall bladder..)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Oil) Division of Radiological Health Office of In Viro Diagnostics and Radiological I tealth 510(k)

.

. . ..

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Page 2 of 3

510(K) Premarket Notification - Sterile Transducers

Page 3

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DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

Device Name: Hitachi ProSound Alpha 6 K093488 Transducer: UST-5311 Intended use: Diagnostic ultrasound imaging or fluid Now analysis of the human body as follows:

Clinical Application		Mode of Operation
General(Track I only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppler	Combined*(Specify)	Other**(Specify)
Ophthalmic	Ophthalmic
	Fetal
Fetal Imaging& Other	Abdominal
	Intra-operative (Specify)*		E	E		E	E	E
	Intra-operative (Neurosurgery)	E	E	E		E	E	E
	Laparoscopic**
	Pediatric
	Small Organ (Specify)*
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify)*
	Other: Gynecological
Cardiac	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac - Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
PeripheralVessel	Peripheral Vascular
	Other (spec.)

N = new indication. P = previously cleared by FDA: E = added under Appendix I - Specifications

Combination of each operating mode includes:

I Combination of each operating mode- BM, BIPWD, BICD/PWD, BICD/CWD * 2 Includes: Mflow, B/B/B/V, Power Tlow.

Intra-operative (Specify)® - (liver, pancreas, gall bladder.)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription Use Only (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k)

Page 3 of 3

510(K) Premarket Notification - Sterile Transducers

, t+ .

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.