The Oral Osteodistraction Distraction Rod Appliances is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

Device Description

Distraction Osteogenesis Rod Appliances are used for mandibular bone distraction.

The major components include:

1. KLS Martin bone plates and screws.
Ormco Stainless steel crowns, Herbst Rods. 2.
1. Leone expansion screws.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Oral Osteodistraction Distraction Rod Appliances." It's important to note that a 510(k) submission generally does not require the robust clinical studies with acceptance criteria and performance data that you would expect for new, high-risk devices or software. Instead, it demonstrates "substantial equivalence" to a predicate device already on the market.

Therefore, the information you're asking for, such as detailed acceptance criteria, a specific study proving it meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is typically not present in a 510(k) submission for a device of this type (a physical implantable device, not an AI/software device).

The document you provided focuses on:

Device Description and Intended Use: What the device is and what it's for.
Predicate Devices: Identifying similar devices already legally marketed.
Comparison Chart: Demonstrating that the new device is substantially equivalent to the predicate devices based on materials, distraction rate, fixation methods, activation, placement, and intended use. This comparison is the "study" for substantial equivalence.

Here's how I can address your points based on the provided text, while also explaining why some information is absent:

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

Acceptance Criteria & Device Performance (Based on Substantial Equivalence):

Feature	Acceptance Criteria (Predicate Devices - KLS-Martin & Synthes)	Reported Device Performance (Oral Osteodistraction)
Material	TI - 6AL4V Titanium Alloy / Surgical Stainless Steel	Stainless Steel 304
Facial Skeleton/Pins	TI - 6AL4V Titanium Alloy / Surgical Stainless Steel	Stainless Steel 301
Distraction Rate	1mm/day	.5mm/day first 2 days, then 1mm/day after that
Fixed to Patient Bone	Screws	Screws
Completed Distraction	Geared Rod	Geared Rod
Distraction Activation	Hex Key / Screwdriver External	Hex Key
Facial Bone Distractor	Intraoral / Internal	Intraoral
Intended Use	Mandible Distraction	Mandible Distraction
Device Placement	Subcutaneous	Subcutaneous
User	Craniofacial Surgeon	Craniofacial Surgeon

Explanation: The "acceptance criteria" here are implicitly the characteristics of the legally marketed predicate devices. The "reported device performance" is the description of the Oral Osteodistraction device. The comparison aims to show that the new device is sufficiently similar to the predicates, or where it differs, the differences do not raise new questions of safety or effectiveness. For instance, the material difference (Stainless Steel 304 vs. Titanium Alloy/Surgical Stainless Steel) or the slight variation in initial distraction rate (.5mm/day first 2 days, then 1mm/day vs. 1mm/day) would have been evaluated by the FDA to determine if they affect substantial equivalence.

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

Sample Size: Not applicable. This 510(k) submission does not present a clinical study with a "test set" as one would for a diagnostic or AI device. The "test" is the comparison against predicate devices' specifications and intended use.
Data Provenance: Not applicable. No clinical data is presented for this substantial equivalence 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 was no "test set" and no ground truth established by experts in a clinical study for this 510(k). The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate devices, as understood by the FDA and the medical community.

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

Not applicable. No clinical test set or adjudication method outlined.

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 device is a physical intraoral distractor, not an AI or software device, and therefore MRMC studies are irrelevant in this context.

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

Not applicable. This device is a physical intraoral distractor, not an algorithm.

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

For demonstrating substantial equivalence: The "ground truth" is the regulatory acceptance and established safety and effectiveness of the legally marketed predicate devices (KLS-Martin Intraoral Distractor K973275 and Synthes Mandibular Distractor K962272). This relies on prior FDA clearances and generally accepted medical and engineering principles for such devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence to predicate devices, rather than a clinical trial report with specific acceptance criteria and detailed performance studies for a novel device or AI.

Summary

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K014001

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

FEB 0 4 2003

Submitter of 510(k):	Oral Osteodistraction, L.P.600 Lake Cook Rd., Suite 150Buffalo Grove, IL 60089
	Phone:	847-215-7554
	Fax:	847-215-7563
Contact Person:	Yan Razdolsky
Date of Summary:	October 10, 2001
Trade Name:	Oral Osteodistraction Distraction Rod Appliances (Rod 1, Rod 2and Rod 3)
Classification Name:	External Mandibular Fixator and/or Distractor
Predicate Device:

KLS-Martin	Intraoral Distractor	K973275
Synthes	Mandibular Distractor	K962272

Intended Use:

Device Description:

Distraction Osteogenesis Rod Appliances are used for mandibular bone distraction.

The major components include:

1. KLS Martin bone plates and screws.
Ormco Stainless steel crowns, Herbst Rods. 2.
1. Leone expansion screws.

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Comparison Chart

	Oral Osteogenesis	KLS-Martin	Synthes
Material	Stainless Steel 304	TI - 6AL4VTitanium Alloy	SurgicalStainless Steal
FacialSkeleton/Pins	Stainless Steel 301	TI - 6AL4VTitanium Alloy	SurgicalStainless Steal
Distraction Rate	.5mm/day first 2 days then1mm/day after that	1mm/day	1mm/day
Fixed to PatientBone	Screws	Screws	Screws
CompletedDistraction	Geared Rod	Geared Rod	Geared Rod
DistractionActivation	Hex Key	Same	ScrewdriverExternal
Facial BoneDistractor	Intraoral	Intraoral	Internal
Intended Use	Mandible Distraction	Same	Same
Device Placement	Subcutaneous	Same	Same
User	Craniofacial Surgeon	Same	Same

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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 an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 4 2003

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

Re: K014001

Trade/Device Name: Oral Osteodistraction Rod Appliances Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: November 26, 2002 Received: December 9, 2002

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 - Mr. Ward

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.

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) 594-4613. 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.

Susan Runres

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): 长 0 | 中 ○ ○ |

Oral Osteodistraction Distraction Rod Appliances Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-

Susan Rower

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

510(k) Number. K014001

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.