The ASU-1000 and Volume mode software, like other marketed diagnostic ultrasound systems and 3-D rendering packages, is indicated for imaging body structures in two and three dimensions to aid in the diagnosis of disease or abnormality.

Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal. Combined Modes: B/M, B/PWD. Other Indications or Modes: 3-D rendering of fetal and maternal structures in Obstetrics.

Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Fetal, Abdominal. Combined Modes: B/M, B/PWD, M/CD, B/PWD/CD. Other Indications or Modes: 3-D rendering of fetal and maternal structures in Obstetrics.

Device Description

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka ASU-1000 transducer and associated Volume Mode 3-D rendering software. The proprietary name for the transducer is the Aloka ASU-1000 diagnostic ultrasound transducer. The 3-D rendering software is "Volume Mode". The common name for this type of device is a diagnostic ultrasound transducer and associated accessories. The Aloka ASU-1000 and Volume mode software can be used on the Aloka SSD-1700 and SSD-1400 diagnostic ultrasound systems. These systems function in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into slice images. The slice images are processed by the Volume Mode software into a 3-D surface rendering of the target tissues.

AI/ML Overview

The provided text is a 510(k) summary for the Aloka ASU-1000 transducer and associated Volume Mode 3-D rendering software. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, much of the requested information regarding an acceptance criteria table, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document as it does not contain such a study report.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are explicitly stated in the document. The basis for clearance is "substantial equivalence" to existing devices, implying that its performance is considered comparable, not necessarily meeting a predefined quantitative threshold.
The document lists several qualitative statements about how the device performs similarly to or is acceptable in comparison to other marketed devices. These can be considered the "performance" aspects being highlighted for substantial equivalence, though they are not numerical acceptance criteria.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (as stated in the document)
Diagnostic Ultrasound Applications: Indicated for imaging body structures in two and three dimensions to aid in the diagnosis of disease or abnormality.	"The ASU-1000 and Volume mode software are indicated for the same diagnostic ultrasound applications as other products currently marketed."
Gray-scale and Doppler Abilities: Comparable to other Aloka products and market competitors.	"The ASU-1000 and Volume mode software have the same gray-scale and Doppler abilities as other products currently offered by Aloka and others."
3-D Rendering Abilities: Comparable to other available products.	"The ASU-1000 and Volume mode software have the same 3-D rendering abilities as products currently available."
Technology Used: Essentially the same as other marketed products.	"The ASU-1000 and Volume mode software uses essentially the same technologies for imaging, Doppler functions and signal processing as other products currently marketed by Aloka and others."
Methods of Use: Similar to other marketed products.	"The ASU-1000 and Volume mode have similar methods of use as other products currently marketed by Aloka and others."
Acoustic Power Output Levels: Below maximum FDA allowed levels.	"The ASU-1000 acoustic power output levels are below the maximum levels allowed by the FDA."
Quality Assurance: Subjected to the same QA systems as other Aloka products.	"The ASU-1000 and Volume mode software are subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka."
Patient Contact Material Safety: Safe for application.	"The patient contact material used in the ASU-1000 has been evaluated and found to be safe for this application."
Electrical and Physical Safety Standards: Complies with the same standards as other Aloka products.	"The ASU-1000 and Volume mode software complies with the same electrical and physical safety standards as other products currently marketed by Aloka."

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

Not explicitly stated. The document does not describe a clinical study with a "test set" in the context of AI/algorithm performance. The clearance is based on substantial equivalence to predicate devices, implying that the established safety and effectiveness of the predicate devices are extended to this new device based on its similar design and performance characteristics.

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

Not applicable. No such test set or ground truth establishment process is described in this document.

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

Not applicable. No test set requiring adjudication is described.

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:

No, an MRMC study was not done or reported. This filing precedes the widespread use of sophisticated AI in medical devices and focuses on hardware (transducer) and basic 3D rendering software, not AI-assisted interpretation.

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

No, a standalone algorithm performance study was not done or reported. The "Volume Mode 3-D rendering software" is a post-processing tool that works with the transducer to create 3D images for human interpretation, not an autonomous diagnostic algorithm.

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

Not applicable. No specific ground truth for performance evaluation of an algorithm is mentioned. The device's indications for use are "to aid in the diagnosis of disease or abnormality," implying that the final diagnosis (ground truth) would still be established by a clinician.

8. The sample size for the training set:

Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence, not a machine learning model developed with a training set.

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

Not applicable. As per point 8, no training set for a machine learning model is mentioned.

Summary

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510(k) SUMMARY 1.

MAR 1 8 1998

This summary statement complies with 21 CFR, section 807.92 as amended March 14, l ddd i

This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka ASU-1000 transducer and associated Volume Mode 3-D rendering software. The address is:

10 Fairfield Boulevard Wallingford, CT. 06492

The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.

The proprietary name for the transducer is the Aloka ASU-1000 diagnostic ultrasound transducer. The 3-D rendering software is "Volume Mode". The common name for this type of device is a diagnostic ultrasound transducer and associated accessories.

The items in this submission are covered under the following classifications:

90 ITX - Transducer, Ultrasonic, Diagnostic 90 IYN - Ultrasonic pulsed Doppler system and accessories

The above as stated in 21 CFR, part 892.1570, and 892.1550 have been classified as regulatory Class II.

The Aloka ASU-1000 and Volume mode software are substantially equivalent to several previously marketed 3-D rendering systems for ultrasound including the TomTek Echo-Scan system.

The ASU-1000 and Volume mode software can be used on the Aloka SSD-1700 and SSD-1400 diagnostic ultrasound systems. These systems function in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into slice images. The slice images are processed by the Volume Mode software into a 3-D surface rendering of the target tissues.

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The ASU-1000 and Volume mode software are indicated for the same diagnostic . ultrasound applications as other products currently marketed.
The ASU-1000 and Volume mode software have the same gray-scale and Doppler . abilities as other products currently offered by Aloka and others.
The ASU-1000 and Volume mode software have the same 3-D rendering abilities as . products currently available.
The ASU-1000 and Volume mode software uses essentially the same technologies for . imaging, Doppler functions and signal processing as other products currently marketed by Aloka and others.
The ASU-1000 and Volume mode have similar methods of use as other products . currently marketed by Aloka and others.
The ASU-1000 acoustic power output levels are below the maximum levels allowed . by the FDA.
The ASU-1000 and Volume mode software are subjected to the same Quality . Assurance systems in development and production as other products currently marketed by Aloka.
The patient contact material used in the ASU-1000 has been evaluated and found to be ● safe for this application.
The ASU-1000 and Volume mode software complies with the same electrical and . physical safety standards as other products currently marketed by Aloka.

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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 depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 8 1998

Paul D. Smolenski Manager, Ouality and Regulatory Affairs Aloka Co., Ltd. 10 Fairfield Blvd. Wallingford, CT 06492

K974544 Re: Aloka ASU-1000 Diagnostic Ultrasound Transducer Dated: March 5, 1997 Received: March 6 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX

Dear Mr. Smolenski:

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 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the Aloka ASU-1000 Diagnostic Ultrasound Transducers intended for use with the following diagnostic ultrasound systems, as described in your premarket notification:

System Model Number

Aloka SSD-1700 Aloka SSD-1400

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 regulations 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 53 t and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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Page 2 - Paul D. Smolenski

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 premaket notification" (2) CPR
807.97). Other general information on your responsibilities un Small Manufacturers 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".

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

Yurid L. Lymm
Lillian Yin, Ph.D.

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K974544

Ultrasound Device Indications Statement

Page 1 of 2

510(k) Number (if known):	unknown at submission
Device Name:	ASU-1000 with Volume Mode 3-D Software
System:	SSD-1400

Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging and Doppler analysis of the human body as Indications for Use: follows:

	MODES of OPERATION
Clinical Application	A	B	M	PW D	CWD	Color Doppler	Amplitude Doppler	CVI	Combined	Other
Opthalmic
Fetal		✓	✓	✓					See Below	See Below
Abdominal		✓	✓	✓					See Below	See Below
Intra-Operative
Intra-Operative
Neurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

Combined Modes: B/M, B/PWD

Other Indications or Modes:3-D rendering of fetal and maternal structures in Obstetrics.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluatition (ODE)

Daniel Leyson

Prescription Use (Per 21 CFR 801.109)

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

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K974544

Ultrasound Device Indications Statement

Page 2 of 2

unknown at submission 510(k) Number (if known): ASU-1000 with Volume Mode 3-D Software Device Name: SSD-1700 System:

Fill our one form for each ultrasound system and transducer

Diagnostic Ultrasound imaging and Doppler analysis of the human body as Indications for Use: follows:

	MODES of OPERATION
ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	CVI	Combined	Other
Opthalmic
Fetal		✓	✓	✓		✓	✓		See Below	See Below
Abdominal		✓	✓	✓		✓	✓		See Below	See Below
Intra-Operative
Intra-OperativeNeurological
Pediatric
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraluminal
Peripheral Vessel
Laparoscopic

Combined Modes: B/M, B/PWD, M/CD, B/PWD/CD Other Indications or Modes:3-D rendering of fetal and maternal structures in Obstetrics.

(PLEASE DQ NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED.) > ---- -- -Concurrence of CDRH, Office of Device Evaluatition (ODE)

David le Lynn
Division Sign Off

ivision Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De

510(k) Number KG974544

Prescription Use (Per 21 CFR 801.109)

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.