(341 days)
The MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
The MaxFace Maxillofacial Ostheosynthesis System is composed of plates and screws, which are available in four different kit sizes: Cranio, Micro, Standard, and Macro systems.
The provided 510(k) summary for the MaxFace Maxillofacial Osteosynthesis System does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
This document describes a medical device, its intended use, and its substantial equivalence to predicate devices, but it does not detail performance metrics, clinical studies, or AI/algorithm-based testing. Therefore, I cannot provide the requested table or details regarding acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies.
Based on the provided text, the device's substantial equivalence was demonstrated through "Bench performance testing." However, the details of this testing, including specific acceptance criteria, results, or the methodology that would align with the requested AI/algorithm-focused questions, are not present.
Here's an explanation of why the requested information cannot be extracted from the provided text:
- Type of Device: The MaxFace Maxillofacial Osteosynthesis System is a physical medical device (plates and screws) used for surgical fixation, not a software algorithm or AI-driven diagnostic tool.
- Regulatory Pathway: The document is a 510(k) premarket notification. For devices like this, substantial equivalence is often demonstrated primarily through comparison to predicate devices and bench testing, rather than extensive clinical efficacy studies or performance metrics as would be seen for AI/software as a medical device (SaMD).
- Lack of Performance Data: The 510(k) summary explicitly states that equivalence is shown through "Bench performance testing," but it does not provide any data, metrics, or specific acceptance criteria from this testing. There are no reported device performance values, sensitivities, specificities, or other statistical measures.
- No AI/Algorithm Component: The device described is a physical implant. The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC studies," or "standalone algorithm performance" are not applicable to the description of this particular device.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or other details related to AI/algorithm performance.
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OCT 2 9 2008
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information:
BIO-TECHNOLOGY USA, INC. 6175 NW 167th Street, Unit # G-8 Miami, Florida, 33015
Date Summary Prepared: October 10, 2008
Contact Persons:
Krista Oakes Emergo Group, Inc. 1705 S. Capital of Texas Hwy., Suite 500 Austin, TX 78746
Telephone: 512-327-9997 FAX: 512-327-9998
Device Name:
Trade Name(s): MaxFace Maxillofacial Ostheosynthesis System Classification Name: Bone Plate Classification Regulation: 21 CFR 872.4760 Panel: Dental
Predicate Device Information:
This device is substantially equivalent to the KLS Martin Micro-Osteosynthesis System, marketed under K944565, and the Synthes Craniofacial Plates, marketed under K021642.
Device Description:
Product Code: JEY
The MaxFace Maxillofacial Ostheosynthesis System is composed of plates and screws, which are available in four different kit sizes: Cranio, Micro, Standard, and Macro systems.
The MaxFace Maxillofacial Ostheosynthesis System is indicated for Intended Use: trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
Contraindications include:
- · Exposed plates and screws
- · Fixations on the dental area
- · Local infection
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Comparison to Predicate Device:
This device is equivalent to the predicate device in intended use and physical characteristics.
Testing and Conclusions:
Bench performance testing demonstrates substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bio-Technology USA, Incorporated Clo Ms. Krista Oakes Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Hightway, Suite 500 Austin, Texas 78746
OCT 2 9 2008
Re: K073307
Trade/Device Name: MaxFace Craniomaxillofacial Osteosynthesis System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: October 13, 2008 Received: October 16, 2008
Dear Ms. Oakes:
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 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.
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Page 2 -- Ms. Oakes
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 your 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clive S.Liao, Ph.D.
Chiu S. Lin. Ph. D Division 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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Indications for Use
510(k) Number (if known): K073307
Device Name: MaxFace Craniomaxillofacial Osteosynthesis System
Indications for Use: The MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
Contraindications include:
- · Exposed plates and screws
- · Fixations on the dental area
- · Local infection
Prescription Use XX (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qur
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073307
§ 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.