The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Clinical Indications are as follows:

· Tumor Resections
Severe trauma which make continuous bone segments no longer possible
· Bone grafting defects
· Severe open mandibular fractures
· Facial deformity corrections

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "Normed Bone Transport" (also referred to as the ACE/Normed Transport Distraction Device). This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific, pre-defined acceptance criteria in the way a clinical trial for a new drug or a novel high-risk device might.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not present. The clearance is based on substantial equivalence, not a performance study as described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
Adjudication method for the test set: Not applicable/not present.
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: This device is a mechanical distraction device, not an AI-powered diagnostic or assistive technology. Therefore, this type of study is not relevant and not present.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present for the clearance determination.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

Device Name: Normed Bone Transport / ACE/Normed Transport Distraction Device
Regulatory Class: II
Product Code: JEY
Indications for Use: Designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. Specifically, it's indicated for maxillofacial alveolar and small craniofacial skeletal bones, with clinical indications including tumor resections, severe trauma, bone grafting defects, severe open mandibular fractures, and facial deformity corrections.
Contraindications: Insufficient available bone, poor bone quality, generalized diseases, allergies, or habits that may contribute to poor healing or osteogenesis (e.g., uncontrolled diabetes, blood dyscrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene). Requires good medical health status and history, plus a radiographic evaluation of anatomical conditions.

To find the kind of detailed study information you're asking for, you would typically need to consult a 510(k) summary (if available publicly in more detail than this letter), a premarket approval (PMA) application, clinical study reports, or peer-reviewed publications associated with the device if such studies were conducted and published. The provided letter is merely the FDA's decision regarding substantial equivalence.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

J. Edward Carchidi, D.D.S. President Ace Surgical Supply Company, Incorporated 1034 Pearl Street P.O. Box 1710 Brockton, Massachusetts 02403

Re : K990140 Normed Bone Transport Trade Name: Regulatory Class: II Product Code: JEY January 15, 1999 Dated: Received: January 19, 1999

Dear Dr. Carchidi:

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 aqainst 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 regulations 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) regulation (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 - Dr. Carchidi

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 general 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,

Patriaux Cusenite ffe

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): K990140

ACE/NORMED TRANSPORT DISTRACTION DEVICE DEVICE NAME:

INDICATIONS FOR USE:

Indications:

Clinical Indications are as follows:

· Tumor Resections
Severe trauma which make continuous bone segments no longer possible
· Bone grafting defects
· Severe open mandibular fractures
· Facial deformity corrections

Contraindications:

The ACE/Normed Transport Distraction Device is contraindicated in patients with insufficient available bone, poor bone quality, and generalized diseases, allergies or habits (uncontrolled diabetes, blood dvcrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene, etc.) that may contribute to poor healing or osteogenesis formation of bone. The patient's good medical health status and history is mandatory. In addition, a radiographic evaluation to examine the anatomical condition of the patient for proper use of the defined surgical protocol is required.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) Susan
(Division Sign-Off)
Over-The-Counter-Use
(Optional Format 1-2-1
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 9901411

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.