The Olympus Ultrasonic System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intrabdominal procedures in general(open) surgery. Also it has been designed to be used with them to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

Device Description

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

(1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
(2) Olympus SonoSurg Transducer SonoSurg-T2H.
(3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).
This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus Ultrasonic Surgical System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from extensive clinical studies with acceptance criteria in the manner typically seen for novel medical devices or software.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth procedures, and MRMC studies for device performance is largely not applicable in this context.

Here's why and what information can be extracted or inferred:

No explicit acceptance criteria for device performance are listed. The submission relies on demonstrating that the device meets existing safety standards and has technological characteristics "the same as the Predicate Devices."
No clinical study demonstrating the device meets acceptance criteria is presented. The document explicitly states: "When compared to the predicate devices, 'Olympus Ultrasonic Surgical System' does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety."
This is not an AI/Software as a Medical Device (SaMD) submission. Therefore, questions related to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth establishment for AI) are irrelevant.

However, I can provide a table based on the safety standards the device complies with, which function as "acceptance criteria" for the device's design and manufacture.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Safety/Design Standards)	Reported Device Performance (Compliance)
IEC 60601-1 (General Requirements for Basic Safety and Essential Performance)	Device designed, manufactured, and tested in compliance. Meets requirements.
IEC 60601-1-1 (Collateral Standard: Safety Requirements for Medical Electrical Systems)	Device designed, manufactured, and tested in compliance. Meets requirements.
IEC 60601-1-2 (Collateral Standard: Electromagnetic Compatibility)	Device designed, manufactured, and tested in compliance. Meets requirements.

2. Sample size used for the test set and the data provenance
Not applicable. This is not a study requiring a test set of data. The device's safety and efficacy are established through comparison to predicate devices and compliance with recognized consensus standards for design and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no test set requiring expert ground truth for device performance evaluation in this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was presented.

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 is not an AI/SaMD device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device and submission, "ground truth" relates to compliance with safety standards and functional equivalence to predicate devices, rather than diagnostic accuracy or patient outcomes.

8. The sample size for the training set
Not applicable. This is not an AI/SaMD device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.

Summary

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K 031710

510(k) SUMMARY Olympus Ultrasonic Surgical System

This summary of 510(k) safety and effectiveness information is being submitted in I ms bannial 9 the requirements of SMDA 1990 and 21 CFR, Section 807.92.

A. General Information

1. Applicant	Aomori Olympus Co., Ltd.2-248-1, OkkonokiKuroishi-shi, Aomori-ken,036-0357 Japan(Registration No .: 9614641)
2. Submission Correspondent	Mayumi IshiiOlympus Optical Co., Ltd.2951 Ishikawa-cho, Hachioji-shi,Tokyo 192-8507, JapanTEL: 81-426-42-2891FAX: 81-426-42-2291(Registration No .: 8010047)
3. Official Correspondent	Tina Steffanie-OakSenior R.A. AnalystOlympus America Inc.Two Corporate Center Drive, Melville,NY 11747-3157TEL: 631-844-5477FAX: 631-844-5416E-mail: Tina.Steffanie-Oak@olympus.com( Registration No .: 2429304)
B. Device Name, Common Name
1. Device Name :	Olympus Ultrasonic Surgical System
2. Common/Usual Name :	Ultrasonic Surgical System

Classification Name :

Class II Instrument, Ultrasonic Surgical LFL

C. Predicate Devices :

#K990362 Harmonic Scalpel #K972114 Olympus SonoSurg Scissors Set T3000 #K990430 Hand piece #K972114 Olympus Transducer MAJ-336 #K000095 SonoSurg Generator Set SonoSurg-G2 Set

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D. Summary Description of the Device

1. Summary

The Olympus Ultrasonic Surgical System is composed of three sections, (1), (2), and (3).

(1) Olympus SonoSurg Scissors 5mm O.D. T3050" or "Olympus SonoSurg Long Hook 5mm O.D. T3060" or "Olympus SonoSurg Long Scissors 5mm O.D. T3070", or "Olympus SonoSurg Scissors 5mm O.D., HF Series.
(2) Olympus SonoSurg Transducer SonoSurg-T2H.
(3) Olympus SonoSurg Generator Set SonoSurg-G2 Set (SonoSurg-G2, MAJ-51).

This device is intended to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

2. Design

"Olympus Ultrasonic Surgical System" has been designed, manufactured and tested in compliance with Voluntary Safety Standards. It meets the requirements of IEC 60601-1, IEC60601-1-1,IEC60601-1-2.

3. Materials

There are no new patient-contacting materials.

E. Intended Use of the device

Olympus Ultrasonic Surgical System has been designed to be used with the Olympus SonoSurg Generator Set (SonoSurg-G2 Set) and an electrosurgical unit to cut and coagulate soft tissue for laparoscopic and intraabdominal procedures in general(open) surgery. It is also designed to cut and coagulate soft tissue for open and endoscopic procedures in thoracic surgery.

F. Technological Characteristics

Theory of the operation of "Olympus Ultrasonic Surgical System" is that the electrical energy employed in the "Olympus SonoSurg-G2" is changed to mechanical energy by ultrasonic vibration in the "Olympus SonoSurg Transducer SonoSurg-T2H" Therefore, this system can cut and coagulate body tissue by ultrasonic vibration. This system is the same as the Predicate Devices which include, "Olympus SonoSurg Scissors Set T3000(#K972114)", "Olympus Transducer MAJ-336 (#K972114)" and "Olympus SonSurg-G2 (#K000095)".

G. Reason for not requiring clinical data

When compared to the predicate devices, "Olympus Ultrasonic Surgical System" does not incorporate any significant changes that would effect safety or efficacy. Therefore clinical data is not necessary for its evaluation of safety.

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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 or bird symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Aomori Olympus Co., Ltd. c/o Ms. Tina Steffanie-Oak Senior Regulatory Affairs Analyst Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747-3157

Re: K031710

Trade/Device Name: Olympus Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: May 27, 2003 Received: June 2, 2003

Dear Ms. Steffanie-Oak:

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.

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 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.

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Page 2 - Ms. Tina Steffanie-Oak

This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

lo. Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K 031710 510(k) Number(if known): __Not assigned yet. Device Name: Olympus Ultrasonic Surgical System

Indications for Use :

Mark N. Melleum

l, Restorative and Neurological Devices

KO31710 510(k) Number ________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Prescription 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

N/A