The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

Device Description

The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device, the "Oral Osteodistraction Distraction Rod Appliance (Rod 4)." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, many of the requested elements (acceptance criteria, specific study details like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this type of device and submission. The FDA 510(k) process for traditional devices like this focuses on material, design, and functional equivalence to a legally marketed predicate.

Here's what can be extracted and what cannot:

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

Not applicable in the typical sense for a 510(k) of a mechanical device. This submission focuses on demonstrating substantial equivalence to a predicate device based on its materials, intended use, and design principles, rather than performance against pre-defined acceptance criteria from a clinical trial. The "performance" is implicitly deemed equivalent to the predicate.

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. There is no "test set" in the context of clinical data for this type of 510(k) submission.

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. There is no "ground truth" establishment in the context of clinical data for this type of 510(k) submission.

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 a mechanical distraction device, not an AI or software 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 consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of Device and Equivalence Information (as provided in the document):

The submission for the Oral Osteodistraction Distraction Rod Appliance (Rod 4) is a 510(k) premarket notification. The purpose of this submission is to demonstrate that the Rod 4 device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as those devices.

Predicate Devices:

KLS Martin Rigid External Distractor K972047
Oral Osteodistraction Rod Appliances (Rod 1, 2, 3) K014001

Intended Use of Rod 4:
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.

Basis for Substantial Equivalence (derived from the "Comparison Chart"):
The document compares Rod 4 to its predicates based on several key characteristics. The "performance" is implicitly demonstrated through the similarities to the predicate devices, which are already legally marketed.

Characteristic	Oral Osteodistraction Rod 1, 2, 3 (Predicate)	Oral Osteodistraction Rod 4 (Device under review)	KLS Martin (Predicate)	Basis for Equivalence (Rod 4 vs. Predicates)
Material	Stainless Steel 304	Stainless Steel 304	T1-6AL-4V Titanium Alloy	Same as Rods 1, 2, 3. Different from KLS Martin, but material suitability for medical devices is generally established.
Facial Skeleton/Pins	Stainless Steel 301	Stainless Steel 301	T1-6AL-4V Titanium Alloy	Same as Rods 1, 2, 3.
Distraction Rate	0.5mm/day first 2 days, then 1mm/day	Same	1 mm/day	Same as Rods 1, 2, 3. Comparable/within clinical norms for distraction osteogenesis as KLS Martin.
Fixed to Patient Bone	Screws	Screws	Screws	Same as both predicates.
Completed Distraction	Geared Rod	Geared Rod	Geared Rod	Same as both predicates.
Distraction Activation	Hex Key	Same	Same	Same as both predicates.
Facial Bone Distractor	Intraoral	Intraoral	Intraoral and External	Same as Rods 1, 2, 3. Similar to the intraoral component of KLS Martin.
Intended Use	Mandible Distraction	Maxillary	Maxillary	Matches KLS Martin for maxillary use, but extends the use of Oral Osteodistraction rods to maxillary (Rods 1-3 were for mandible).
Device Placement	Subcutaneous	Same	Same	Same as both predicates (referring to the internal components/fixation).
User	Craniofacial Surgeon	Same	Same	Same as both predicates.
Site of Distraction	Tooth-borne	Tooth-borne	Tooth-borne and External	Same as Rods 1, 2, 3. Similar to the tooth-borne aspect of KLS Martin.
Latency Period	5-7 Days	Same	Same	Same as both predicates.
Distraction Period	7-14 Days	Same	Same	Same as both predicates.
Consolidation Period	8-12 Weeks	Same	Same	Same as both predicates.
Surgical Technique	Osteotomy	Same	Same	Same as both predicates.
Placement (Internal/Ext)	Internal	Internal	External	Same as Rods 1, 2, 3 (internal). Different from KLS Martin (which is external), highlighting the Rod 4's intraoral/internal nature as a differentiator.

Key Finding from the 510(k) process:
The FDA determined that the device is substantially equivalent to the predicate devices for its stated indications for use. This means the FDA believes it is as safe and effective as the existing devices on the market. The primary difference noted (and justified for equivalence) is the shift in intended use for the "Rod" type device from mandibular to maxillary distraction, aligning its intended use with the KLS Martin predicate. The physical and operational characteristics are largely similar to or variations of the Rod 1, 2, 3 series.

Summary

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MAR 2 3 2004

510(K) SUMMARY (as required by 807.92(c)) K034045

Submitter of 510(k):	Oral Osteodistraction, L.P.600 W. Lake Cook Rd., Suite 150Buffalo Grove, IL 60089
	Phone:	847-215-7554
	Fax:	847-215-7563
Contact Person:	Yan Razdolsky
Date of Summary:	March 14, 2004
Trade Name:	Oral Osteodistraction Distraction Rod Appliances (Rod 4)
Classification Name:	External Maxillary Fixator and/or Distractor - MQN
Predicate Device:	KLS Martin Rigid External Distractor K972047Oral Osteodistraction Rod Appliances (Rod 1,2,3) K01400

Intended Use:

Device Description:

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Comparison Chart

	Oral OsteodistractionROD 1, 2, 3 -K014001	Oral OsteodistractionRod 4	KLS Martin -K972047
Material	Stainless Steel 304	Stainless Steel 304	T1-6AL-4V TitaniumAlloy
FacialSkeleton/Pins	Stainless Steel 301	Stainless Steel 301	T1-6AL-4V TitaniumAlloy
Distraction Rate	.5mm/day first 2 daysthen 1mm/day after that	Same	1 mm/day
Fixed to PatientBone	Screws	Screws	Screws
CompletedDistraction	Geared Rod	Geared Rod	Geared Rod
DistractionActivation	Hex Key	Same	Same
Facial BoneDistractor	Intraoral	Intraoral	Intraoral and External
Intended Use	Mandible Distraction	Maxillary	Maxillary
DevicePlacement	Subcutaneous	Same	Same
User	Craniofacial Surgeon	Same	Same

Rod 4 is essentially the same as Rods 1-3 except for the location of axis change.

Additional Comparison

	Oral OsteodistractionROD 1, 2, 3 – K014001	OralOsteodistractionRod 4	KLS Martin -K972047
Site of Distraction	Tooth-borne	Tooth-borne	Tooth-borne andExternal
Latency Period	5-7 Days	Same	Same
Distraction Period	7-14 Days	Same	Same
Consolidation Period	8-12 Weeks	Same	Same
Surgical Technique	Osteotomy	Same	Same
Placement	Internal	Internal	External

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird with three curved lines representing its wings or feathers.

Public Health Service

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oral Osteodistraction, L.P. C/O Mr. Arthur Ward RMS, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K034045

Trade/Device Name: Oral Osteodistraction Distraction Rod Appliance (Rod 4) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 1, 2003 Received: December 29, 2003

Dear Mr. Ward:

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.

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Page 2 - Ms. Rivkowich

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 (OS) 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). please contact the Office of Compliance at (301) 594-5613. 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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034045 510(k) Number (if known):

Oral Osteodistraction Distraction Rod Appliance (Rod 4) Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Swen

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

510(k) Number: J

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.