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

Device Description

The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.

AI/ML Overview

The provided text describes the SMARTO device, a surgical motor unit, and outlines its technical specifications and comparison with a predicate device for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of AI-driven performance metrics (e.g., sensitivity, specificity, AUC).

The document is a 510(k) summary for a surgical motor unit. The "acceptance criteria" discussed are related to electrical safety, electromagnetic compatibility, and performance tests for torque and speed, using existing standards (IEC 60601-1, IEC 60601-1-2) and internal standards. These are typical for hardware medical devices.

Therefore, I cannot fulfill parts of your request that pertain to performance metrics like sensitivity, specificity, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these types of studies and criteria are generally associated with AI/software medical devices that interpret images or data for diagnostic or prognostic purposes.

Here is what can be extracted from the document regarding the acceptance criteria and study, based on the provided text's focus on a physical medical device:

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

Acceptance Criteria Category	Standard/Test	Acceptance Criteria	Reported Device Performance
Electrical Safety	IEC 60601-1	Compliance with IEC 60601-1	"The test results demonstrated that the proposed device complies with the following standards"
Electromagnetic Compatibility	IEC 60601-1-2	Compliance with IEC 60601-1-2	"The test results demonstrated that the proposed device complies with the following standards"
Performance Test (Torque)	Internal standard	Met internal standard for torque based on changed specifications of DC motor and unit of battery.	For DC Motor: 45 Ncm (increased from 24 Ncm)For 111-ED-031: 30 Ncm (increased from 24 Ncm)For 111-ED-050: 45 Ncm (increased from 24 Ncm)For 111-ED-051: 40 Ncm (increased from 24 Ncm)For 111-ED-052: 35 Ncm (increased from 24 Ncm)
Performance Test (Speed - RPM)	Internal standard	Met internal standard for RPM based on changed specifications of DC motor and unit of battery.	For DC Motor: 210 RPM (increased from 160 RPM)For 111-ED-031: 250 RPM (increased from 160 RPM)For 111-ED-050: 210 RPM (increased from 160 RPM)For 111-ED-051: 165 RPM (increased from 160 RPM)For 111-ED-052: 110 RPM (decreased from 160 RPM)

Notes:

The document states, "The test was conducted to verify that the proposed device met all design specifications." and "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." This implies that the device did meet these criteria.
The specific magnitude of the acceptance criteria for the internal standards is not explicitly stated as a pass/fail threshold, but the reported performance values are given. The inference is that the reported performance meets the internal standard.

Regarding the other requested information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device (physical surgical motor). The "tests" are engineering performance tests, not clinical studies with patient data.
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): Not applicable. "Ground truth" in this context refers to the measured physical properties of the device against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For physical characteristics like torque and speed, the "ground truth" would be the measured physical properties against designed specifications. For electrical safety and EMC, it's compliance with established international standards.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

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

December 27, 2016

Jeil Medical Corporation Mr. Jaehan Park RA Manager #702 Kolon Science Valley 2nd, 55, Digital-ro34, Guro-gu, Seoul, 152-728 South Korea

Re: K163308

Trade/Device Name: SMARTO Regulatory Class: Unclassified Product Code: KIJ Dated: November 17, 2016 Received: November 23, 2016

Dear Jaehan Park:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation 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) K163308

Device Name SMARTO

Indications for Use (Describe)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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K163308

Image /page/3/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3535.

510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared [21 CRF 807.92(a)]

November 2016

2. Submitter's Information

• Name of Sponsor:	Jeil Medical Corporation
- Address:	#702 Kolon Science Valley 2nd, 55, Digital-ro34, Guro-gu,Seoul, 152-728, Korea
• Contact Name :	Seungyong Lee / RA Specialist
- Telephone No. :	+82 2 850 3533
- Fax No. :	+82 2 850 3525
- Email Address :	leesy@jeilmed.co.kr
• Registration Number :	3004049923
• Name of Manufacturer:	Same as Sponsor
- Address:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

• Trade Name:	SMARTO
• Common Name:	Surgical motor unit for surgery
• Product Code:	KIJ
• Device Class:	Unclassified

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follow;

510(k) Number: K101563
Applicant: Jeil Medical Corporation
Common Name: Surgical motor unit for surgery
Device Name: SMARTO

Surgical motor unit for surgery

There are no significant differences between the Additional models and the predicate devices(K101563)that would adversely affect the use of the product.

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K163308

Image /page/4/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION, along with their address and contact information. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533, and the fax number is +82 2 850 3535.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

510(k) Number: K101563
Applicant: Jeil Medical Corporation
· Common Name: Surgical motor unit for surgery
SMARTO • Device Name:

5. Description of the Device [21 CFR 807.92(a)(4)]

The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.

6. Intended Use [21 CFR 807.92(a)(5)]

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

7. Technological Characteristics [21 CFR 807.92(a)(6)]

SMARTO: With same indication and operational principle. But, dimension and specification changed some specifications of DC motor have increased for the effective use to indication under the predicate (unmodified) devices (K101563)

Non-Clinical Test Summary:

The test was conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and worst case criteria report:

Electrical Safety: IEC 60601-1
Electromagnetic Compatibility: IEC 60601-1-2
Performance Test Torque: Internal standard Speed (RPM): Internal standard

The subject device has the same device characteristics as the predicate( unmodified) device.

Summary of the changed specification:

Part or spec.	Description of changes	Remark
Body of Product	ShapePart of assemble with switchPart of assemble with holder assy
Switch Rubber	ShapeRound → Square
	Dimension$Ø$ 8.0 mm → width 12.5 mm

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Image /page/5/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is +82 2 850 3533 and the fax number is +82 2 850 3535.

Holder Assy	Shape	Part of assemble with mechanical lock
DC Motor	Torque	24Ncm → 45Ncm
DC Motor	Speed (RPM)	160 RPM → 210 RPM
PCB	PCB PatternAdd Switch
Mechanical Lock	Add new part & function
Unit of Battery(1.5V AAA Alkaline)	111-ED-050	2.0ea → 4ea
	111-ED-031, 051	2.0ea → 3ea
Performance(Torque)	111-ED-031	24Ncm → 30 Ncm
	111-ED-050	24Ncm → 45 Ncm
	111-ED-051	24Ncm → 40 Ncm
	111-ED-052	24Ncm → 35 Ncm
Performance(RPM)	111-ED-031	160 RPM → 250 RPM
	111-ED-050	160 RPM → 210 RPM
	111-ED-051	160 RPM → 165 RPM
	111-ED-052	160 RPM → 110 RPM

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, materials, energy source, design & use concept and sterilization. The differences are technical specification (Torque, Motor speed) and supply power.

However the performance and safety test data provided in this submission prove that this differences do not raise new issues in safety and performance.

9. Conclusion [21 CFR 807.92(b)(3)]

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 SMARTO is safe and effective and substantially equivalent to the predicate (unmodified) device as described herein.

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.