OSTEOMED INTRAORAL DISTRACTION SYSTEM by OSTEOMED CORP.

Indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Device Description

The OsteoMed Intraoral Distraction System is a subcutaneous bone distractor. It features various curved and straight bars activated with a threaded wire that has screw holes that are fixed to bone via 1.6mm bone screws. The distractor is available in right and left versions: The threaded wire is activated by a hex driver and is capable of distraction lengths of up to 25mm.

AI/ML Overview

This document is a 510(k) Summary for the OsteoMed Intraoral Distraction System, and as such, it focuses on demonstrating substantial equivalence to previously approved devices rather than presenting a performance study with detailed acceptance criteria and reported device performance.

Therefore, the information you've requested about acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth for a study proving the device meets acceptance criteria is not present in this 510(k) submission.

Here's why and what information is available:

510(k) Submissions and Substantial Equivalence: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is primarily done through showing similarities in intended use, technological characteristics, and often by comparing performance to the predicate device if there are differences that raise new questions of safety or effectiveness. For devices like this one, based on mature technology, the primary evidence often revolves around material and design similarity, and existing clinical history of predicate devices.
Absence of a Performance Study: The submission explicitly states: "Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues." This statement indicates that a new, extensive performance study with pre-defined acceptance criteria, as one might see for a novel diagnostic algorithm or a drug, was not deemed necessary for this submission. The demonstration of equivalence relies on the established safety and effectiveness of the predicate devices.

Based on the provided text, I can answer your questions as follows:

A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not provide a table of acceptance criteria or specific reported device performance data from a new study designed to prove the device meets such criteria. The submission relies on substantial equivalence to predicate devices (Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and Howmedica Guerrero-Bell Distractor (K972166)).
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. No new test set or data provenance is mentioned as part of a performance study for this submission.
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. No experts were used for a new ground truth establishment related to a performance study for this device's submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method is mentioned.
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 mechanical surgical distractor, not an AI or imaging diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant to its approval.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a mechanical surgical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No new ground truth data was generated for a performance study. The "ground truth" for the submission's approval is essentially the FDA's acceptance of the safety and effectiveness of the predicate devices based on their prior approvals and established clinical use.
The sample size for the training set:
- Not Applicable. This is a mechanical device, not an algorithm requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set was used.

Summary

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K9909444

Image: OSTEOMED CORPORATION logo
	510(k) Summary
	Device Proprietary Name:	OsteoMed Intraoral DistractionSystem
	Device Common Name:	Intraoral Distractor
specializedorthopaedicproducts	Classification Name:	MQN, External MandibularFixator and/or Distractor
craniofacialreconstructionproducts	Name of Submitter:	OsteoMed Corporation3750 Realty RoadAddison, Texas 75001Phone: (972) 241-3401Fax: (972) 241-3507
new productdevelopment	Contact Person:	Dawn T. Holdeman
	Date Prepared:	March 19, 1999
	Summary:

This submission describes the OsteoMed Intraoral Distraction System indicated for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions mav include diagnoses such as mandibular micrognathia or hemifacial microsomia.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Leibinger Vazquez-Diner Intraoral Distraction Device (K964649) and the Howmedica Guerrero-Bell Distractor (K972166).

Due to the similarity of materials and design to both pre-enactment and postenactment devices. OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1999

Ms. Dawn T. Holdeman Document Control and Regulatory Affairs OsteoMed Corporation 3750 Realty Road Addison, Texas 75001

Re : K990944 OsteoMed Intraoral Distraction System Trade Name: Regulatory Class: II Product Code: MON Dated: March 19, 1999 Received: March 22, 1999

Dear Ms. Holdeman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Holdeman

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Osteomed Intraoral

Indications For Use:

Indicated for use as a mandibular bone Indicated for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rosiner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use (Pcr 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.