(182 days)
Intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adjacent Alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.
The OsteoMed Alveolar Distraction System is a distraction osteogenesis system consisting of two bone plates, a threaded rod and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument. The distractor is capable of distraction lengths of up to 20mm.
The provided text is a 510(k) summary for the OsteoMed Alveolar Distraction System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles.
Therefore, the study described does not involve a statistical evaluation of device performance against specific acceptance criteria in the way medical imaging or diagnostic AI devices do. It relies on the assertion that "Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Intraoral Distraction System does not raise any new safety or effectiveness issues."
As a result, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document because such a performance study was not conducted or reported in this 510(k) submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not describe specific numerical acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the device. The substantial equivalence argument is based on design and material similarities to predicate devices, not on a performance study with defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Cannot be provided. There is no mention of a "test set" or a performance study involving patient data. The equivalence is based on device design and material comparison.
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 / Cannot be provided. There was no test set requiring ground truth establishment related to clinical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. No test set or related adjudication method is described.
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 / Cannot be provided. This is not an AI device, and no MRMC study or human reader improvement analysis is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided. This is a mechanical device, not an algorithm, so "standalone performance" in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Cannot be provided. No ground truth for clinical performance was established or used in this submission.
8. The sample size for the training set
- Not applicable / Cannot be provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. No training set or ground truth for it exists for this type of submission.
Summary of the Study provided in the 510(k):
The "study" presented in this 510(k) is a substantial equivalence determination based on a comparison to predicate devices, rather than a performance study with clinical data.
Description of the Study:
The OsteoMed Alveolar Distraction System's 510(k) submission (K030790) establishes its substantial equivalence to legally marketed predicate devices. The basis for this determination is described as similarities in:
- Intended Use: All devices are used for gradual bone distraction to increase bone height and mass in the mandible or maxilla.
- Material: The devices are made of similar materials.
- Design: The fundamental design principles involving bone plates, a threaded rod, and an activation instrument for gradual expansion عبر an osteotomy are common.
- Operational Principle: The mechanism of distraction osteogenesis through controlled expansion is consistent across the devices.
The predicate devices cited for comparison are:
- KLS-Martin TRACK 1.0mm and 1.5mm System (K002152)
- Leibinger Chin Distractor (K973484)
- Lorenz Distraction System (K992952)
The core argument is that, due to these similarities, the OsteoMed Alveolar Distraction System "does not raise any new safety or effectiveness issues" compared to already cleared devices. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, without necessarily performing new clinical trials if the engineering and material equivalence is strong.
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510(k) Summary
Device Proprietary Name:
Device Common Name:
Classification Name:
Name of Submitter:
OsteoMed Alveolar Distraction System
Intraoral Distractor
MQN. External Mandibular Fixator and/or Distractor
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-6401
Contact Person:
Date Prepared:
Dawn T. Holdeman
March 10, 2003
Summary:
This submission describes the OsteoMed Alveolar Distraction System intended for use in patients who have totally or partially edentulous mandible or maxilla or small craniofacial bone deficiencies and need an increase in bone height and mass by means of distraction osteogenesis. These patients include those who have traumatic defects, periodontal disease or birth abnormality. The alveolar distractor is designed to provide temporary stabilization and gradual expansion across an osteotomy in the mandibular bone or maxillary bone and thereby increasing the height of the adiacent alveolar ridge. This device is intended to be removed after consolidation of the callus and prior to final prosthetic reconstruction. The OsteoMed Alveolar Distraction System is intended for single patient use only.
The OsteoMed Alveolar Distraction System is a distraction osteogenesis system consisting of two bone plates, a threaded rod and an activation instrument. The plates attach to bone using bone screws and then gradually distract the osteotomized segment via activation of the threaded rod with the activation instrument. The distractor is capable of distraction lengths of up to 20mm.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin TRACK 1.0mm and 1.5mm System (K002152), the Leibinger Chin Distractor (K973484), and the Lorenz Distraction System (K992952).
Due to the similarity of materials and design to predicate 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 the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.
Public Health Service
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K030790
Trade/Device Name: Osteomed Alveolar Distraction System Intraoral Distractor Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: June 16, 2003 Received: June 17, 2003
Dear Ms. Holdeman:
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 vour 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. Holdeman
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 vour 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 vours.
Suzafunz
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
Enclosure
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OsteoMed "Indications for Use" Submission
510(k) Number:
03079
| Device Name: | Osteomed Alveolar Distraction System |
|---|---|
| Indication for Use: | Intended for use in patients who have totally orpartially edentulous mandible or maxilla or smallcraniofacial bone deficiencies and need anincrease in bone height and mass by means ofdistraction osteogenesis. These patients includethose who have traumatic defects, periodontaldisease or birth abnormality. The distractor isdesigned to provide temporary stabilization andgradual expansion across an osteotomy in themandibular bone or maxillary bone and therebyincreasing the height of the adjacent Alveolar ridge.This device is intended to be removed afterconsolidation of the callus and prior to finalprosthetic reconstruction.The OsteoMed Alveolar Distraction System isintended for single patient use only. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)
Kein Muly for MSR
(Divis Division of Anesthesiolo Infection Control, Denta
510(k) Number: K030746
§ 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.