The Telescopic Distractor is an intraoral, subcutaneous distractor which is used for mandibular distraction osteogenesis. The device is indicated for use in patients with congenital micrognathia, post-traumatic mandibular deformities, or defects resulting from tumor resection. In conjunction with osteotomy or corticotomy, the Telescopic Distractor may be used for:

mandibular body lengthening; .
mandibular ramus lengthening;
distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis; and
transport distraction osteogenesis across a mandibular segmental . defect in the ramus, body, or symphysis.

Device Description

Innova Corporation requests marketing clearance for the Telescopic Distractor, an intraoral subcutaneous device that permits either unilateral lengthening of the mandible. The device consists of forward and rear telescoping bodies that are held together by a central element. The subject device is designed with a central element that can be moved in opposing directions by turning an adjustment screw, producing the telescopic action. The telescoping bodies are attached to the inferior border of the mandibular osteotomy with bone plates and screws. The telescopic elements slide freely in the central element. The maximum amount of distraction possible between the two sections is 18 millimeters. A circular pin and a separate adjustment screw attaches the forward telescoping element to the forward bone plate. The circular pin provides a rigid, interlocking connection because of the snug fit within the opening in the forward telescoping element. The forward bone plate can be moved transversely relative to the telescopic elements by the adjustment screw. The rear telescopic element is similarly connected to the rear bone plate. The forward and rear bone plate elements are secured to the mandible with four bicortical stainless steel bone screws. Following placement of the distractor, the clinician waits for a period of 5 to 10 days to allow for intraoral healing prior to initiating distraction. The Innova Telescoping Distractor is made from wrought surgical grade stainless steel. The material conforms to ASTM F 138-97. This material is currently used in a variety of implanted devices such as bone plates and has a demonstrated biocompatibility by its long history of use for implant applications. The Telescoping Distractor is available in two models; unilateral and bilateral. The devices are operated and applied in an identical manner, except that the unilateral model is intended for distraction osteogenesis of either the right or the left side of the mandible. while the bilateral model is intended to be used for simultaneous distraction osteogenesis of both the right and left sides of the mandible.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Innova Telescopic Distractor. This type of FDA submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through a traditional clinical study with acceptance criteria.

Therefore, the document does not report acceptance criteria or a study designed to prove the device meets such criteria in the way a clinical trial would. Instead, it focuses on comparing the new device to an existing, cleared device.

However, I can extract information related to the device's technical characteristics and intended use, which inherently imply certain performance expectations, and describe the comparison methodology used.

Here's a breakdown based on your request, adapted to the nature of a 510(k) submission:

Acceptance Criteria and Reported Device Performance (Implied by Substantial Equivalence Claim)

Since this is a 510(k) submission, there aren't explicit "acceptance criteria" in the sense of predefined thresholds for a study to demonstrate safety and effectiveness. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The "device performance" reported is largely a description of its features and how they align with the predicate.

Characteristic/Performance Aspect	Innova Telescopic Distractor (Subject Device)	Predicate Device (Howmedica Mandibular Distractor II, K960297)	Implied "Acceptance" (Substantial Equivalence)
Intended Use	Mandibular distraction osteogenesis	Mandibular distraction osteogenesis	Met: Both devices are intended for the same clinical purpose (mandibular lengthening).
Principle of Operation	Intraoral subcutaneous device; forward & rear telescoping bodies with adjustment screw	Stabilizer and bone lengthener through distraction of the mandible	Met: Both operate on the principle of distraction osteogenesis to lengthen the mandible.
Maximum Distraction	Up to 18 mm	Not explicitly stated in the provided text for predicate, but implied similar mechanism	Met: The mechanism allows for bone lengthening, with the subject device offering up to 18mm.
Patient Population	Adult, adolescent, or pediatric patients	Adults and children	Met: Both are indicated for a broad age range.
Device Material	Wrought surgical grade stainless steel (ASTM F 138-97)	Not explicitly stated in the provided text for predicate	Met: Use of a biocompatible and established surgical material. The text states the material "is currently used in a variety of implanted devices" and has "demonstrated biocompatibility by its long history of use for implant applications."
Sterilization	Supplied non-sterile; sterilization instructions included; single-use only	Supplied non-sterile; single-use only	Met: Both follow the same non-sterile supply and single-use sterilization protocol.
Models Available	Unilateral and Bilateral	Not explicitly stated in the provided text for predicate	Met: The availability of options addresses different clinical needs, aligning with the functional scope of distraction devices.
Indications for Specific Procedures	Mandibular body lengthening, ramus lengthening, distraction across segmental defect, transport distraction osteogenesis	Same general indications as the subject device (mandibular lengthening, stabilization)	Met: Both cover similar specific applications within the broader mandibular distraction osteogenesis.
Overall Technological Characteristics	Intraoral subcutaneous device, telescoping bodies, adjustment screw, bone plates/screws for attachment	Intraoral device, similar principle of operation for distraction	Met: The submission explicitly states "The devices share similar technological characteristics," focusing on the intraoral, subcutaneous nature and the distraction mechanism.

Study Information (Relevant to a 510(k) Submission)

Sample size used for the test set and the data provenance:
- No "test set" in the traditional sense. A 510(k) notification primarily relies on design and performance characteristics comparison to a predicate device, rather than a prospective clinical study with a "test set" of patients. The "data" used is the description and specifications of both the subject device and the predicate device.
- Data Provenance: The 'data' for the subject device comes from the manufacturer's own design specifications, material selections, and labeling. The 'data' for the predicate device (Howmedica Mandibular Distractor II, K960297) would come from its own 510(k) clearance documentation and publicly available information. This is retrospective in the sense that it relies on existing device data and clearances.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" with ground truth established by experts in a clinical study context. The "ground truth" for a 510(k) is the regulatory finding of "substantial equivalence" by the FDA. The experts involved are the FDA reviewers (e.g., Sandra L. Shire, DMD, MP, Dental Officer), whose qualifications are implied by their roles within the FDA.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set and thus no adjudication method for ground truth. The "adjudication" is the FDA's regulatory review process itself, culminating in the "substantially equivalent" determination.
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:
- No MRMC study was done. This device is a mechanical surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, the concept of "human readers improve with AI" is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical "ground truth." As discussed, the "ground truth" in a 510(k) is the FDA's determination of substantial equivalence, based on a comparison of device characteristics, intended use, and technological principles.
The sample size for the training set:
- Not applicable. There is no "training set" for an algorithm, as this is a mechanical device.
How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm.

Summary

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2/10/99

K984117

1. Intended Use:

Innova Corporation requests clearance to market a Telescopic Distractor, an intraoral device which is intended to permit the lengthening of the mandible. The device is designed to allow either unilateral or bilateral distraction. The Innova Telescopic Distractor can allow for up to 18 mm of distraction. The device is intended for use in adult, adolescent or pediatric patients.

Device Description: 2. SUMMARY:

The subject device is designed with a central element that can be moved in opposing directions by turning an adjustment screw, producing the telescopic action. The telescoping bodies are attached to the inferior border of the mandibular osteotomy with bone plates and screws. The telescopic elements slide freely in the central element. The maximum amount of distraction possible between the two sections is 18 millimeters.

A circular pin and a separate adjustment screw attaches the forward telescoping element to the forward bone plate. The circular pin provides a rigid, interlocking connection because of the snug fit within the opening in the forward telescoping element. The forward bone plate can be moved transversely relative to the telescopic elements by the adjustment screw. The rear telescopic element is similarly connected to the rear bone plate. The forward and rear bone plate elements are secured to the mandible with four bicortical stainless steel bone screws.

Following placement of the distractor, the clinician waits for a period of 5 to 10 days to allow for intraoral healing prior to initiating distraction.

The Innova Telescoping Distractor is made from wrought surgical grade stainless steel. The material conforms to ASTM F 138-97. This material is currently used in a variety of implanted devices such as bone plates and has a demonstrated biocompatibility by its long history of use for implant applications.

The Telescoping Distractor is available in two models; unilateral and bilateral. The devices are operated and applied in an identical manner, except that the unilateral model is intended for distraction osteogenesis of either the right or the left side of the mandible. while the bilateral model is intended to be used for simultaneous distraction osteogenesis of both the right and left sides of the mandible.

The device is indicated for the following procedures:

. mandibular body lengthening
mandibular ramus lengthening ●
distraction osteogenesis across a mandibular segmental defect in the ramus, ● body or symphysis
transport distraction osteogenesis across a mandibular segmental defect in the . ramus, body, or symphysis

The device is indicated for use in adult, adolescent and pediatric patients.

The sponsor claims substantial equivalence to the previously cleared devices intended for use in distraction osteogenesis, such as the Howmedica, Inc. Mandibular Distractor II, cleared

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as K960297. The devices share the same intended use and principle of operation. The devices share similar technological characteristics.

The Howmedica Mandibular Bone Distractor II (K960297) was cleared for use in adults and children. The predicate device is intended as both a stabilizer and bone lengthener through distraction of the mandible. The predicate device is supplied non-sterile and is labeled for single use only. The Innova device is also supplied non sterile. Sterilization instructions are included in the draft labeling included as attachment 8 in the document. The labeling clearly statesthat the device is intended for single use only and should therefore not be resterilized for reuse by any method. The product is packaged in Tyvek and is ready for processing in the autoclave.

ANALYSIS:

The subject device, the Innova Telescopic Distractor is substantially Equivalent to previously cleared devices for a similar intended use.

RECOMMENDATIONS:

SUBSTANTIALLY EQUIVALENT

Qandra L. Shute, DMin.

Sandra L. Shire, DMD, MP, Dental Officer, DeDB

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Innova Corporation C/O Howard M. Holstein, Esq. Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109

Re : K984117 Innova Telescopic Distractor Trade Name: Requlatory Class: II Product Code: MON November 16, 1998 Dated: November 17, 1998 Received:

Dear Mr. Holstein

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and thạt, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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

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Page 2 - Mr. Holstein

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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) 638-2040 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: Innova Telescopic Distractor

Indications For Use:

mandibular body lengthening; .
mandibular ramus lengthening;
distraction osteogenesis across a mandibular segmental defect in the ramus, body, or symphysis; and
transport distraction osteogenesis across a mandibular segmental . defect in the ramus, body, or symphysis.

The device may be used in adult, adolescent, or pediatric patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)
	Susan Ruopp (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K984117

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.