The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.

Device Description

The OsteoMed ICON IMF (Intermaxillary Fixation) Screw System is offered in 2.4mm and 2.0mm standard IMF screws in lengths from 10mm (thread lengths from 5mm to 15mm) and 2.0mm ICON AutoDrive IMF Screws in lengths from 12mm to 18mm (thread lengths of 8mm).

The implants of the OsteoMed ICON IMF Screw System are made from Titanium alloy (ASTM F-136) and the ligature wire is made from Stainless Steel.

The system instruments include drill bits, wire cutters, pliers, drill guides and screwdrivers to facilitate the placement of screws and ligature wires. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

AI/ML Overview

The provided document describes the mechanical testing required for OsteoMed ICON IMF Screw System to demonstrate substantial equivalence to predicate devices, not acceptance criteria for an AI/ML device study. Therefore, most of the requested information (MRMC study, number of experts, ground truth, training set size, etc.) is not applicable to this document.

However, I can extract the acceptance criteria and performance data for the mechanical tests that were conducted:

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

Test	Acceptance Criteria	OsteoMed ICON IMF Screw System Performance
Failure Torque Testing	Met minimum requirement based on screw diameter (according to ASTM F543)	Met minimum failure torque requirement (according to ASTM F543)
Insertion Torque Testing	FT/IT (Failure Torque/Insertion Torque) ratio > 1.0 (according to ASTM F543)	Met FT/IT ratio of > 1.0 (according to ASTM F543)
Pull-Out Force Testing	Equivalent to predicate device results	Equivalent to predicate device results (as shown in K962774)
Bending Force Testing	Equivalent to predicate device results	Equivalent to predicate device results (as shown in K962774)
Simulated Use	Equivalent to predicate device	Found to be equivalent to the predicate device

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

The document does not specify the exact sample sizes used for each mechanical test. It mentions "all devices" for failure torque and insertion torque, and implicitly a sample of the new devices for pull-out and bending tests. The data provenance is laboratory testing for mechanical properties, not clinical data, so country of origin or retrospective/prospective is not applicable.

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. This is a mechanical device, not an AI/ML device relying on expert interpretation for ground truth.

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

Not applicable. This is mechanical testing against engineering standards and predicate device performance, not clinical data requiring adjudication.

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 document is for a medical device (IMF Screw System), not an AI/ML diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this device's performance is established by engineering standards (ASTM F543) and comparison to the established performance of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 21,2015

Osteomed Piedad Pena Regulatory Affairs Manager 3885 Arapaho Rd Addison, Texas 75001

Re: K151195

Trade/Device Name: Osteomed Imf Screw Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 4, 2015 Received: September 10, 2015

Dear Piedad Pena:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K151195

Device Name: OsteoMed ICON IMF Screw System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

OsteoMed ICON IMF Screw System

Name of Submitter:	OsteoMed3885 Arapaho RoadAddison, TX 75001972 677 4600972 677 4601 (fax)
Contact Person:	Mrs. Piedad Pena, M.S.
Date Prepared:	September 4, 2015
Device Proprietary Name:Device Common Name:Classification Name:Product Code:	OsteoMed ICON IMF Screw SystemIMF Fixation Screw and wire21CFR 872.4880: Intraosseous fixation screw or wireDZL

Primary Predicate: OsteoMed QUICK-FIX, K962774 Classification Name: 21CFR 872.4880: Intraosseous fixation screw or wire; Product Code: DZL; Class: II

Reference Predicate: Auto-Drive Bone Screw System, K974785 Classification Name: 21CFR 888.3040, Smooth or threaded metallic fixation fastener, Product Code HWC, Device Class: II

Summary:

Device Description:

The implants of the OsteoMed ICON IMF Screw System are made from Titanium alloy (ASTM F-136) and the ligature wire is made from Stainless Steel.

Intended Use/Indications for Use:

The OsteoMed ICON IMF Screws System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.

OsteoMed 3885 Arapaho Road Addison, Texas 75001 (973) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779

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Summary of Technological Characteristics:

System / DeviceName/510(k)/Purpose	OSTEOMED ICON IMF ScrewSystem (New)	OSTEOMED Quick-fix SystemK962774Primary Predicate	OsteoMed Auto-DriveBone Screw K974785(Reference Predicate)self-driving tip features
Classification	Class II21 CFR 872.4880DZL	Class II21 CFR 872.4880DZL	Class II21 CFR 888.3040HWC
Device NameClassification:	Intraosseous fixation screw orwire.	Intraosseous fixation screw orwire.	Smooth or threadedmetallic bone fixationfastener.
	a) Identification. Anintraosseous fixation screw orwire is a metal device intendedto be inserted into fracturedjaw bone segments to preventtheir movement.	a) Identification. Anintraosseous fixation screw orwire is a metal device intendedto be inserted into fractured jawbone segments to prevent theirmovement.
Indication forUse/IntendedUse	The device is intended andindicated for the temporaryligature and wire lock fixationfor temporary constriction andstabilization of fracture bonesegments in the oral cavity inconjunction with primaryfixation devices.	The device is intended andindicated for the temporaryligature and wire lock fixationfor temporary constriction andstabilization of fracture bonesegments in the oral cavity inconjunction with primaryfixation devices.	Fixation secondary totrauma orreconstruction of thecraniofacial andmaxillofacial skeleton andbones of thehand
Technology	The screws fixate on bone inconjunction with ligature wireto allow fixation andstabilization of the fracture.	The screws fixate on bone inconjunction with ligature wire toallow fixation and stabilizationof the fracture.	The screws fixate on bonein conjunction with platesfor rigid fixation.(N/A, this device does notused plates)
Screw Drivingtechnology forimplantation	The standard screws areimplanted after a pilot hole hasbeen created in the desiredlocation.AutoDrive screws do notrequire pilot hole forimplantation, they are self-drilling screws.	The standard screws areimplanted after a pilot hole hasbeen created in the desiredlocation.	AutoDrive screws do notrequire pilot hole forimplantation, they are self-drilling screws.
Screw Material	Ti6Al4V per ASTM F136	Ti6Al4V per ASTM F136	Ti6Al4V per ASTM F136
Principles ofOperation	Rigid Fixation and Wire Lockstabilization	Rigid Fixation and Wire Lockstabilization	Rigid Fixation

	Table 1: Technology Comparison to the Primary Predicate and Reference Device

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System / DeviceName/510(k)/Purpose	OSTEOMED ICON IMF ScrewSystem (New)	OSTEOMED Quick-fix SystemK962774Primary Predicate	OsteoMed Auto-DriveBone Screw K974785(Reference Predicate)self-driving tip features
Screw(type and lengthrange accordingto screwdiameter)	2.4mm IMF Screw (standard)Length range: 10mm-20mmThread range: 5mm to 15mm(Same as Primary Predicate;cleared K962774)2.0mm IMF Screw (standard)Length range: 10mm-20mmThread range: 5mm to 15mm2.0mm IMF AutoDrive ScrewLength range: 12mm-18mmThread range: 8mm-14mm	2.4mm IMF Standard ScrewLength range: 10mm-20mmThread range: 5mm to 15mm(Cleared)	2.0mm AutoDrive ScrewLength range: 4mm-8mmThread range: 3mm-7mm(Cleared)
Instrumentation(Materials)	• Stainless Steel• Anodized aluminum• Medical grade polymer	• Stainless Steel• Anodized aluminum• Medical grade polymer	• Stainless Steel• Anodized aluminum• Medical grade polymer
Instrumentation	drill bits, wire cutters, pliers,drill guides and screwdrivers tofacilitate the placement ofscrews and ligature wire	drill bits, wire cutters, pliers,drill guides and screwdrivers tofacilitate the placement ofscrews and ligature wire	screwdrivers to facilitatethe placement of screws
Sterilization	Packaged and sold Non-sterile,requires sterilization prior touse	Packaged and sold Non-sterile,requires sterilization prior to use	Packaged and sold Non-sterile, requiressterilization prior to use
Biocompatibility	Ti alloy per ASTM F136 is abiocompatible material	Ti alloy per ASTM F136 is abiocompatible material	Ti alloy per ASTM F136 is abiocompatible material

Substantial Equivalence Discussion:

The OSTEOMED 2.0mm ICON Standard IMF Screw and the 2.0mm ICON AutoDrive IMF Screw are the same as the predicate device (2.4mm QuickFix MMF Screw, K962774) in the following ways:

The screws have the same Regulatory Classification (21 CFR 872.4880 DZL)
The screws have the same indication for use.
The technology and features of the screws are the same (screws to fixate and allow ligature with wire)
The range of the screw length is the same as, or encompassed by, that of the predicate:
- o Overall Length = 10mm 20mm
- o Thread Length = 5mm 15mm
. The length of the screw head, the head diameter, and cross-sectional areas through the wire holes are the same as the predicate device.
. The 2.0mm ICON Standard IMF Screw has the same number of wire fixation holes (1) as the predicate

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The screws are manufactured from the same materials (Titanium alloy per ASTM F136) as the predicate and therefore have the same biocompatibility.
The instrumentation and materials used in conjunction with these screws are the same
The screws are packaged and sterilized in the same manner and same parameters as the predicate device.

Differences between the new devices and the predicate, do not affect safety and effectiveness

The 2.0mm ICON AutoDrive IMF Screw has more wire fixation holes (2) than the predicate (1) ●
The 2.0mm ICON Standard IMF Screw has a smaller cross-sectional area through the wire fixation holes (1.43 mm²) than the predicate (2.04 mm²)
The 2.0mm ICON AutoDrive IMF Screw has a different tip (sharp, pointed, single threadcutting flute) than the predicate (blunt, rounded) but was equivalent to the reference predicate.

The performance testing comparison listed below showed the new devices were equivalent and did not raise new safety and effectiveness issues.

Performance/Clinical Data:

The OsteoMed ICON IMF Screws (2.0mm Standard IMF screws and the 2.0mm AutoDrive IMF screws) were compared to the OsteoMed QuickFix 2.4mm standard MMF Screws (K962774-primary predicate) and the 2.0mm AutoDrive Screws (K974785-reference predicate). The 2.0mm AutoDrive IMF screws and the 2.0mm standard IMF screws underwent verification testing to ensure that the design features meet the required mechanical strength criteria for their intended use compared to the predicate device. The intended use of the OsteoMed ICON IMF Screw System is the same as OsteoMed 2.4mm QuickFix screw system (K962774).

The performance testing included failure torque testing of the new devices and the predicate devices in accordance with ASTM F543. All devices met the minimum failure torque requirement based on screw diameter according to the standard. Also, insertion torque testing in accordance with ASTM F543 was performed for all devices met the required failure torque to insertion torque (FT/IT) ratio of FT/IT > 1.0 according to the standard. Lastly, pull-out force and bending force testing was performed on the new devices using equivalent methods to those shown in the primary predicate 510k K962774 and compared against the predicate device results in K962774. The performance testing showed that the new devices were equivalent to the predicate device. Simulated use was performed as part of validation for the new screws and were found to be equivalent to the predicate device.

Biocompatibility and Sterilization testing was justified to the already tested predicate device. No changes to materials, packaging, or sterilization were made, therefore the new devices are equivalent to the predicate device.

OsteoMed believes that these non-clinical tests have demonstrated that these devices are safe and effective as the predicate device; therefore, clinical testing is not required to support substantial equivalence.

Substantial Equivalence:

The substantial equivalence of the OsteoMed ICON IMF Screw System is based on similarities in intended use, indications for use, material, function, technology, performance, design, sterilization, and operational principles to the OsteoMed QuickFix (K962774, primary predicate) and design, material and operating principles as the AutoDrive self-drilling features for the OsteoMed AutoDrive Bone Screw (K974785) reference predicate.

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Conclusion:

Substantial equivalence was shown through failure torque testing, insertion torque testing, pull-out force testing, and bending testing when compared to known standards and to the predicate devices. The indications, design, technology and operational principles are similar between the subject devices and primary predicate OsteoMed 2.4mm QuickFix MMF Screw (K962774), and reference predicate OsteoMed 2.0mm AutoDrive Screw (K974785), therefore OsteoMed believes that the OSTEOMED 2.0mm ICON Standard IMF Screw and OSTEOMED 2.0mm ICON AutoDrive IMF Screw do not raise any new safety or effectiveness issues.

The assessment of the non-clinical data demonstrated the devices were as safe and effective as the predicate devices OsteoMed QuickFix (K962774) and AutoDrive Bone Screw (K974785). In conclusion, the OsteoMed IMF Screw System have been evaluated and proven to be substantially equivalent to the predicate device.

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Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.