The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.

Device Description

The SMARTO is a sterile battery powered screwdriver. The device includes a DC motor, battery, switch and holder for the rotation attachment. It is disposable.

AI/ML Overview

The provided document describes a 510(k) submission for the SMARTO surgical motor unit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on a defined performance standard.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, an AI algorithm, or detailed statistical analysis, is not applicable to this type of regulatory submission. This document describes a traditional medical device (a surgical motor unit), not an AI-powered device or one that requires extensive clinical performance studies to achieve marketing clearance via the 510(k) pathway.

Here's a breakdown of the available information and why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Substantial Equivalence to Predicate	Performed "Bench testing on mechanical properties; motor speed, torque." Results show "safety and effectiveness of the SMARTO."
Mechanical properties (motor speed)	Bench test results indicate safety and effectiveness.
Mechanical properties (torque)	Bench test results indicate safety and effectiveness.
Safety and Effectiveness	Bench test results indicate safety and effectiveness.
Intended Use	Matches predicate: drive screws, drilling for craniofacial, craniotomies, hand, foot, wrist, extremity reconstruction.
Technology	Substantially equivalent to predicate.
Energy Source	DC motor, battery; substantially equivalent to predicate.
Claims	Substantially equivalent to predicate.
Material Composition	Substantially equivalent to predicate.
Sterile, Single Use	Yes, designed to be sterile and for single use.

Explanation: For a 510(k) submission like this, "acceptance criteria" are primarily established by demonstrating substantial equivalence to a legally marketed predicate device. The performance criteria are therefore implied to be met if the new device performs comparably to the predicate for its intended use. Bench testing of mechanical properties (motor speed, torque) is mentioned as evidence of safety and effectiveness, which are the fundamental requirements.

Information NOT available or NOT applicable based on the provided document:

2. Sample size used for the test set and data provenance: Not applicable. The document refers to "bench testing" on mechanical properties, but details such as sample size, specific test configurations, or data provenance (country, retrospective/prospective) are not provided. This is not a clinical study with a "test set" in the sense of patient data.
3. Number of experts used to establish ground truth and qualifications: Not applicable. There is no mention of "ground truth" established by experts in this context as this is a mechanical device, not an AI or diagnostic tool.
4. Adjudication method: Not applicable. No expert review or adjudication process is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not applicable. This type of study is for diagnostic devices where human readers interpret data, often with AI assistance. The SMARTO is a surgical motor.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. The SMARTO is a physical surgical tool, not an algorithm.
7. Type of ground truth used: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome for a diagnostic or AI study. For a surgical motor, the "truth" is its mechanical performance and functional safety.
8. Sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
9. How the ground truth for the training set was established: Not applicable. No AI model or training set.

In summary, the provided document is a 510(k) summary for a surgical motor. Its primary goal is to establish substantial equivalence through bench testing of mechanical properties and comparison of intended use, technology, energy source, claims, and material composition with a predicate device. It does not contain the detailed study information typically associated with AI/ML devices or complex clinical performance studies.

Summary

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ATTACHMENT 1

Image /page/0/Picture/1 description: The image shows the logo for Jell Medical Corporation. The logo consists of a black square with a white line running through it on the left side. To the right of the square is the text "Jell Medical Corporation" in a bold, sans-serif font. Above the corporation name are the words "we make smile" in a smaller font.

DEC 1 7 2018

702, Kolon Science Valley 2nd, 811

Guro-Dong, Guro-Gu, Seoul, 152-050 Korea
Tel: +82 2 850 3500 / Fax: +82 2 850 3535

510(k) Summary

K101563

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

October 19, 2010 Date: Date:

Company and Correspondent making the submission:

	Company
Name	Jeil Medical Corporation
Address	#702, kolon science valley 2nd811, Guro-Dong, Guro-GuSeoul, Republic of Korea 152-050
Phone	+82 2 850-3500
Fax	+82 2 850-3535
Contact	Jieun Kim

2. Device:

Proprietary Name - SMARTO Common Name - Surgical motor unit for surgery Classification Name -- Instrument, Surgical orthopedic, DC-powered motor and accessory/attachment

3. Predicate Device:

The OSTEOMED "B" power system and accessories, K933101

1. Classifications Names & Citations: KIJ, Unclassified

5. Description:

The device includes a DC The SMARTO is a sterile battery powered screwdriver. motor, battery, switch and holder for the rotation attachment. It is disposable.

6. Indication for use:

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Guro-Dona, Guro-Gu, Seoul, 152-05 Tel : +82 2 850 3500 / Fax : +82 2 850 3

Review:

The SMARTO is substantially equivalent to the commercially available predicate products based on the intended use, technology, energy source, claims, and the material composition employed. Accordingly we can claim the substantially equivalence of the SMARTO to predicate devices.

1. Summary of performance testing:
  Bench testing has been performed on mechanical properties; motor speed, torque. The results of Bench test show the safety and effectiveness of the SMARTO.
1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that the SMARTO are safe and effective and substantially equivalent to predicate devices as described herein.

END

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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 eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

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

DEC 1 7 2010

Jeil Medical Corporation % GS Standard Co., Ltd. Kim Seong Nam 1006 Digital 2 Cha Valley Byucksan, Gasan-Seoul Republic of Korea

Re: K101563

Trade/Device Name: SMARTO Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachment Regulatory Class: Class I Product Code: KIJ Dated: December 05, 2010 Received: December 08, 2010

Dear Kim Seong Nam:

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.

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Page 2 - Kim Seong Nam

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers; International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 3

510(k) Submission - SMARTO

510(k) Number K101563

Device Name: SMARTO

Indication for use:

The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

OR Over-The-Counter Use Prescription Use (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden for mxm

ical, Orthopedic, tive Devices

510(k) Number K101563

Regulation Number and Section

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.