This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. For use in adults over the age of 12.

Device Description

This device is designed for orthodontic use. The screws are made of alloy (ASTM F 136-98). The head of the screw is dual head type. The upper head is a hex type. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, Dual head design of screw mandible and mannia in the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The tip of the screw is designed available to self-drilling and self-tapping. (Surgeon's option) This device is comprised of screws ranging in diameter of 1.4mm to 2.0mm and in length ranging from 6.0mm to 12mm. These screws are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. Therefore, and device mast Polyethylene package. The top of packaging bag is sealed with sealing strip.

AI/ML Overview

This looks like information from a 510(k) premarket notification for a medical device, specifically the "Dual Top Anchor System Screws". These documents are generally used to demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with defined acceptance criteria in the same way one might for a novel device requiring a PMA.

Therefore, the typical "study that proves the device meets the acceptance criteria" in the context of a 510(k) usually involves comparing the new device's characteristics (material, design, intended use) to those of the predicate device and showing they are substantially equivalent, rather than conducting a full-blown clinical trial with performance metrics.

Based on the provided text, here's a breakdown of the requested information, noting that much of it is not directly applicable or explicitly stated as would be in a clinical study report:

1. Table of acceptance criteria and the reported device performance

In a 510(k) submission, "acceptance criteria" for performance are not typically presented as quantitative metrics with corresponding "reported device performance" values in the same way a clinical trial might. Instead, the acceptance criterion is substantial equivalence to a predicate device. The "performance" is the demonstration that all key attributes (material, intended use, design, potential adverse effects) are either identical or do not raise new questions of safety and effectiveness compared to the predicate.

Characteristic	Acceptance Criteria (based on predicate device)	Reported Device Performance (as demonstrated by comparison)
Material	Composed of Titanium Alloy used generally in this kind of bone screw (specifically ASTM F 136-98, as seen in predicate OsteoMed).	Made of Titanium Alloy (ASTM F 136-98). Stated to be "manufactured from material of titanium alloy (ASTM 136-98) that is used generally in this kind of bone screw."
Intended Use	To provide fixed anchorage point for attachment of orthodontic appliances to facilitate orthodontic movement of teeth, used temporarily and removed post-treatment. Single use.	Identical: "This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. For use in adults over the age of 12."
Design/Function	Self-drilling/self-tapping, dual head type (hex upper, lower for appliances), available in various diameters and lengths.	Dual head type (hex upper head, hole for wire, lower for appliances). Tip designed for self-drilling and self-tapping. Ranging in diameter of 1.4mm to 2.0mm and length of 6.0mm to 12mm.
Sterility	Non-sterile, recommended steam sterilization before use (consistent with OsteoMed predicate).	Non-sterile. "Therefore, this device must be sterilized prior to use. Steam sterilization is recommended."
Adverse Effects	Potential adverse effects and complications common to all devices of this type (poor bone formation, loosening, migration, metal sensitivity, pain, necrosis, infection, etc.).	"Potential Adverse Affects and Complications: (Common to all devices of this type)" are listed and are identical to those of already marketed devices.
Overall	Substantially equivalent to OsteoMed Orthodontic Screw System (K031936) and Nobel Biocare Implant Orthodontic Anchor System (K000643).	Concluded to be "substantially equivalent in design, material, intended use and function to the certified by notified body for CE."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This 510(k) submission does not describe a "test set" in the context of a clinical study with patients. The "test set" here would refer to the technical and performance characteristics of the "Dual Top Anchor System Screws" being compared to the predicate devices. The data provenance would be internal company data (Jeil Medical Corporation, Korea) on their device's specifications and comparison to publicly available information on the predicate devices. No human subject data (prospective or retrospective) is mentioned for demonstrating equivalence in this document.

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. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the legally marketed predicate devices. No expert panel is described for evaluating a specific "test set" of performance data for the new device. The evaluation is done by the FDA, based on manufacturers' submitted data and comparisons.

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

Not applicable. There is no mention of a human-adjudicated "test set" for performance evaluation in this 510(k) summary.

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 document pertains to a mechanical medical device (bone screws) and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This is not an algorithmic device.

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

The "ground truth" implicitly used in a 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by regulatory bodies (like the FDA). The current device demonstrates equivalence to this established "ground truth" by showing similar characteristics and lack of new safety/effectiveness concerns.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.

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

Not applicable. There is no "training set" for this device.

Summary

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KO 33767

FEB 2 4 2004

EXHIBIT 2

Jeil Medical Corporation 808. ACE Techno-Tower, 3rd 197-48, Kuro 3Dong Kuro-Ku, Seoul, KOREA Telephone : 82-2-2109-6781~9 Fax: 82-2-2109-6791 Revised February 17, 2004 Contact: N.K.Kim, R&D Director 510(k) Summary of Safety and Effectiveness

Identification of the Device: 1. Proprietary-Trade Name: Dual Top Anchor System Screws (various models) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Bone Screw
Equivalent legally marketed devices: OsteoMed Orthodontic Screw System, (K031936), 2. Equivancen legary manett(K982509) the Nobel Biocare Inplant Orthodontic Anchor System (K000643) ..
Indications for Use (intended use) . This device is intended to provide a fixed anchorage point 3. for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only. For use in adults over the age of 12.
1. Description of the Device: This device is designed for orthodontic use. The screws are made Description of alloy (ASTM F 136-98). The head of the screw is dual head type. The upper head is a hex type. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, Dual head design of screw mandible and mannia in the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The tip of the screw is designed available to self-drilling and self-tapping. (Surgeon's option) This device is comprised of screws ranging in diameter of 1.4mm to 2.0mm and in length ranging from 6.0mm to 12mm. These screws are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. Therefore, and device mast Polyethylene package. The top of packaging bag is sealed with sealing strip.
Potential Adverse Affects and Complications: (Common to all devices of this type) 5.
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, . or oon can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
- Migration, bending, fracture or loosening of the implant. .
- Metal sensitivity, or allergic reaction to a foreign body. .
- Pain, discomfort, or abnormal sensation due to the presence of the device. .
- Increased fibrous tissue response around the fracture site and/or the implant. .
- Necrosis of bone. .
- . Inadequate healing.
  - madequate neaming.
    Apart from these adverse effects there are always possible complications of any surgical

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procedure such as, but not limited to, infection, nerve damage, and pain which may not be related to the implant

Device Name	Nobel BiocareImplant OrthodonticAnchor System	OsteoMedOrthodontic ScrewSystem,	Dual Top Anchor SystemScrews (various models)
Device ClassificationName	Implant, Endosseous,Product Code DZE	Implant, Endosseous,Product Code DZE	Implant, Endosseous, ProductCode DZE
Applicant	Nobel BioCare	Osteomed	Jeil Medical Corporation
510(K) Number	(K000643).	(K031936)	(This submission)
Material	Titanium	Titanium Alloy	Titanium Alloy(ASTM F 136-98)
Intended use	This device is intendedto provide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. It is usedtemporarily and isremoved afterorthodontic treatmenthas been completed.Screws are intended forsingle use only.	This device is used as ananchorage for orthodontictreatment in the mouth.	This device is intended toprovide a fixed anchoragepoint for attachment oforthodontic appliances tofacilitate the orthodonticmovement of teeth. It is usedtemporarily and is removedafter orthodontic treatment hasbeen completed. Screws areintended for single use only.For use in adults over the ageof 12.
Single Use?	YES	YES	YES
Supplied Sterile?	No comment	Non sterile, steamsterilize before use	Non sterile, steam sterilizebefore use

1. Safety and Effectiveness, comparisons to predicate devices:
Conclusion: In all respects, the Dual Top Anchor System Screws (various models) Bone 7. Conclusion: In an respects, the Butan of currently marked devices. They are materials Screws are the equivalent of earling markets as the consection adverse effects are identical to allu have similar difficits and enazacts manufactured from material of titanium alloy (ASTM 136-98) that is used generally in this kind of bone screw. Similar devices made from (ASTM 136-98) that is used generally in this never are manufactured and sold around the world.
titanium alloy (ASTM 136-98) to this device are manufactured and sold around to this device is substantially equivalent in design, material, intended use and function to the This device is substantially orquiral with the certified by notified body for CE.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that suggest wings or feathers, and the overall design is simple and modern.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Jeil Medical Corporation C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K033767

Trade/Device Name: Jeli Medical Corporation: Dual Top Anchor Systems Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 20, 2003 Received: December 3, 2003

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 approvisions 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 (1 Mr), it hay of badyoo in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kamm

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 una libing (21 CF C 1 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.

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), rt you deente the Office of Compliance at (301) 594-4613. 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,

Chiu Lin, Ph., D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO33767

Indications for Use

510(k) Number (if known): __K033767

Device Name:_Jeil Medical Corporation:__Dual Top Anchor System Screws

Indications For Use:

This device is intended to provide a fixed anchorage point for attachment of othodontic This device is intended to provide a liked anchorage point of used temoved appliances to faciliate the othroublike movement of tooth. We single use only. For use on adults over the age of 12.

Susan Russer

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.