(246 days)
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
The OsteoMED Low Profile Orbital Floor Plate System is a permanent implant that is provided non sterile and is manufactured from commercially pure Titanium (ASTM F 67). The OSTEOMED Low Profile Orbital Floor Plates are offered with hole sizes which are able to accept 1.2mm and 1.6mm standard and auto drive bone screws and 1.9mm and 1.9mm safety screws and are offered in thicknesses ranging from .2mm to .5mm.
The implant is also provided in a variety of shapes including both nonpreformed shapes and pre formed left and right profiles. The implant is fixed to the infra orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself to reconstruct the orbital floor and/or medial wall in adult patients.
The OsteoMed CFX system which is already available in the marketplace includes the screws (ASTM F136) and instrumentation to facilitate implantation of the Low Profile Orbital Floor Plate System. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade plastic. All instruments included in the CFX system are Class I, standard, manual, surgical instruments.
This document describes a 510(k) premarket notification for the "OsteoMed Low Profile Orbital Plate System". This submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance. It does not describe an AI medical device, but rather a physical implantable device (bone plate). Therefore, many of the requested categories related to AI performance, such as MRMC studies, training set details, and ground truth establishment for algorithms, are not applicable to this document.
However, I can extract information related to the device's performance testing in a general sense, using the available data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for the device's mechanical performance, but rather states that it "meets that of the predicate device". The reported performance is implicitly the successful completion of a verification comparison.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate device (Synthes MatrixMIDFACE System K031761) | Mechanical testing was performed demonstrating the new OsteoMed Low Profile Plate System meets that of the predicate device. Performance equivalence was shown through the verification comparison. |
2. Sample size used for the test set and the data provenance
The document states "Mechanical testing was performed", but does not specify the sample size used for this mechanical testing. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). This type of information would typically be detailed in a separate testing report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a mechanical device testing. "Ground truth" in this context would refer to the physical properties and performance measured, not an expert assessment of an image or data set.
4. Adjudication method for the test set
This is not applicable to mechanical device testing. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies in expert opinions.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices involving human interpretation, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
For mechanical testing, the "ground truth" refers to the measured physical properties and performance characteristics of the device under controlled testing conditions, compared against the known properties of the predicate device. This would likely involve measurements such as strength, durability, and deformation under stress, conducted in a laboratory setting.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning algorithm.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is a physical medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18,2014
OsteoMed c/o Mrs. Piedad Pena, M.S. Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K140978
Trade/Device Name: OsteoMed Low Profile Orbital Plate System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: November 17, 2014 Received: November 18, 2014
Dear Mrs. 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
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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-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Susan Runno DDS, MA
Erin I. Keith, M.S. 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 Statement
K140978 510(k) Number (if known):
OsteoMed Low Profile Orbital Floor Plate System Device Name:
Indications for Use:
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Prescription Use: _X (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
OsteoMed Low Profile Orbital Floor Plate System
Summary Date: November 17, 2014
Submitter Data: OsteoMed 3885 Arapaho Road Addison, TX 75001 972 677 4600 972 677 4601 (fax)
Primary Contact: Mrs. Piedad Pena, M.S.
Device Trade Name: OsteoMed Low Profile Orbital Plate System
Common Name: Orbital Floor Plate System
Classification Name: Plate, bone
Product Code: JEY- Bone Plate
Device Classification: 21 CFR Part §872.4760 - Bone plate
Legally Marketed Predicate Devices:
Synthes MatrixMIDFACE System (K031761) Stryker Universal Orbital Floor Plate System (K123786)
Device Description:
The OsteoMED Low Profile Orbital Floor Plate System is a permanent implant that is provided non sterile and is manufactured from commercially pure Titanium (ASTM F 67). The OSTEOMED Low Profile Orbital Floor Plates are offered with hole sizes which are able to accept 1.2mm and 1.6mm standard and auto drive bone screws and 1.9mm and 1.9mm safety screws and are offered in thicknesses ranging from .2mm to .5mm.
The implant is also provided in a variety of shapes including both nonpreformed shapes and pre formed left and right profiles. The implant is fixed to the infra orbital rim via either the holes on the provided fixation arms or through the anterior screw holes on the plate itself to reconstruct the orbital floor and/or medial wall in adult patients.
The OsteoMed CFX system which is already available in the marketplace includes the screws (ASTM F136) and instrumentation to facilitate implantation of the Low Profile Orbital Floor Plate System. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade
Image /page/3/Picture/18 description: The image shows a logo with the word "Colson" in a stylized font. To the left of the word is a circular emblem with a vertical line extending upwards. To the right of the word "Colson" are the words "A COLSON A".
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plastic. All instruments included in the CFX system are Class I, standard, manual, surgical instruments.
Intended Use/ Indications for Use:
The OsteoMed Low Profile Plate System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit.
The OsteoMed Low Profile Plate System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in adult patients.
Performance Testing:
Mechanical testing was performed demonstrating the new OsteoMed Low Profile Plate System meets that of the predicate device, the Synthes MatrixMIDFACE System.
Performance equivalence was shown through the verification comparison to the predicate Synthes MatrixMIDFACE System (K031761).
Technological Characteristics:
The OsteoMed Orbital Floor Plate System is considered to be substantially equivalent in design, intended use and material to the predicate devices. There are not any design differences between the systems that would affect safety or effectiveness or raise new questions regarding safety and effectiveness.
Sterilization:
The OsteoMed Low Profile Orbital Floor Plate System components are single use, supplied non sterile and require sterilization prior to use.
Substantial Equivalence:
The basis of substantial equivalence for this device is based on similarities in intended use, indications for use, material, function, technology, performance, and operational principles to the predicate device; Synthes MatrixMIDFACE System which was cleared under K031761 on September 3, 2003 and the Stryker Universal Orbital Floor Plate System which was cleared under K123786 on April 9, 2013.
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Device Comparison Chart:
| Features | OsteoMed Low ProfileOrbital Floor PlateSystem (NEW) | Synthes MatrixMIDFACESystem (K031761) | Stryker UniversalOrbital Floor System(K123786) |
|---|---|---|---|
| Intended Use /Indications forUse | Intended Use:The OsteoMed Low ProfileOrbital Floor Plate System isintended to be used in thereconstruction of the floorand/or medial wall of theorbit.Indications for Use:The OsteoMed Low ProfileOrbital Floor Plate System isindicated for thereconstructive treatment ofthe orbital floor and/ormedial wall trauma or boneexcision in adult patients. | IntendedUse/Indications for Use:The Synthes CraniofacialPlate and Screw System isintended for use in selectivetrauma of the midface andcraniofacial skeleton,craniofacial surgery,reconstructive surgery ofthe maxilla and chin.Indications: SynthesMatrixMIDFACE PreformedOrbital Plates are intendedfor trauma repair andreconstruction of thecraniofacial skeleton.-Orbital floor fractures-Medial orbital wallfractures-Combined orbital floor andmedial wall fractures. | Intended Use:The Stryker UniversalOrbital Floor System isintended to be used inthe reconstruction of thefloor and/or medial wallof the orbit.Indications for Use:The Stryker UniversalOrbital Floor System isindicated for thereconstructive treatmentof the orbital floorand/or medial walltrauma or bone excisionin adult patients. |
| Material &Biocompatibility | Plates are manufacturedfrom CP (Pure) Titanium (asper ASTM F67). | Plates are manufacturedfrom CP (Pure) Titanium. | Plates are manufacturedfrom CP (Pure) Titanium,Grade 2. |
| Method ofFixation | Plate fixation with screwsinserted through dedicatedscrew holes. | Plate fixation with screwsinserted through dedicatedscrew holes. | Plate fixation with screwsinserted throughdedicated screw holes. |
| Sterility | Provided as single use, nonsterile | Non sterile/sterile | Provided non sterile |
| Profile(Thickness)Range | .2mm-.5mm | .2mm-.5mm | .3mm-.6mm |
| Screw DiametersAccepted | 1.2mm and 1.6mm screws1.5mm and 1.9mm safetyscrews | 1.5mm screws 1.85 mmsafety screws | 1.2mm and 1.4mmscrews 1.7mm safetyscrews |
| Application Area | CMF/Orbital | CMF/Orbital | CMF/Orbital |
| TargetPopulation | Adults | Unknown | Adults |
| Technology | Plates & Screw Fixation | Plates & Screw Fixation | Plates & Screw Fixation |
| OperationalPrinciple | Reconstruct the orbital floorand/or medial wall. | Reconstruct the orbital floorand/or medial wall. | Reconstruct the orbitalfloor and/or medial wall. |
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a colson associate
§ 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.