(155 days)
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
The XXS Plates utilize the same integrated locking system for screws as the Xtremities Plates cleared in K050681. The titanium plates have PEEK-Optima® inserts which enables the screws to be locked at the desired angle by means of a "self-tapping" effect. The XXS Plats are thinner and smaller diameter screws (1.7mm) have been designed for use in small bones including the metacarpals and phalanges.
The provided text is a 510(k) summary for the TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES. It details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.
The document is a premarket notification for a medical device (bone fixation plates and screws). For this type of device, substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. This often involves comparing design features, dimensions, material composition, and sometimes mechanical testing data. However, detailed study results with acceptance criteria, sample sizes, and ground truth information as requested for AI/software device evaluation are not typically part of a 510(k) for a physical orthopedic implant.
Therefore, for the questions asked, the answer is that the information is not present in the provided document. Devices like the TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES typically rely on mechanical testing (e.g., fatigue, static strength) and biocompatibility testing for safety and effectiveness, rather than clinical studies with human readers or AI algorithms described in the prompt's questions.
Here's a breakdown of why each point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria for a new study.
- Sample size used for the test set and the data provenance: Not present. No specific test set or study data is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This type of information is relevant for studies involving human interpretation (e.g., imaging devices) rather than a physical implant.
- Adjudication method for the test set: Not present.
- If a multi-reader multicase (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 relevant and not present. This is a physical implant, not an AI-powered diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant and not present.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not present. No training set is mentioned as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not present.
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111266 Page 1/2
OCT - 6 2011
510(k) Summary of Safety and Effectiveness TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES
| Submitted/Distributed By: | TriMed, Inc.27533 Avenue HopkinsSanta Clarita, CA 91355(800)633-7221 |
|---|---|
| Registration No.: | 2031009 |
| Manufactured By: | Biotech International305, Allée de Craponne13300 Salon De ProvenceFrance |
| Registration No.: | 3005270144 |
| Prepared By/Contact Person: | Doug SteinbergerPhone: (661)255-7406Fax: (661)254-8485 |
| Proprietary Name: | Mini Plates or XXS Plates |
| Classification: | Class II: Screw, Fixation, BoneHWC – Section 888.3040Class II: Plate, Fixation, BoneHRS - Section 888.3030 |
| Summary Preparation Date: | July 28, 2011 |
Indications for Use:
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
Device Description
The XXS Plates utilize the same integrated locking system for screws as the Xtremities Plates cleared in K050681. The titanium plates have PEEK-Optima® inserts which enables the screws to be locked at the desired angle by means of a "self-tapping" effect. The XXS Plats are thinner and smaller diameter screws (1.7mm) have been designed for use in small bones including the metacarpals and phalanges.
XXS Plates System – Summary of Safety and Effectiveness
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K111266 Page 2/2
Substantial Equivalence Discussion
When compared to the predicate devices listed below, substantial equivalence is based upon similarities in design features and dimensions, overall indications for use, and material composition.
| 510(k) Number | Device Name or System | Manufacturer |
|---|---|---|
| K050681 | EasyLock Osteosystem | Manufactured By:Biotech InternationalDistributed By:TriMed, Inc. |
| K081546 | Small Bone LockingPlating System | DePuy Orthopaedics |
| K961497 | Profyle Hand and SmallFragment System | Stryker, Howmedica |
The new product does not change the intended use or scientific principles used for safe and effective implantation.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling human figures or waves, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
TriMed Inc. % Doug Steinberger 27533 Avenue Hopkins Santa Clarita CA 91355
001 - 6 2011
Re: K111266
Trade/Device Name: EasyLock Osteosystem XXS Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS/HWC Dated: September 2010, 2011 Received: September 2316, 2011
Dear Mr. Steinberger:
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.
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Page 2 - Mr. Doug Steinberger
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-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 go to http://www.fda.gov/About/DA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Pop
Mark N. Melkerson
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
unknown K11266 510(k) Number (if known):
EasyLock Osteosystem XXS Plates Device Name:
Indications For Use:
The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.
× Prescription Use (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)
Ntuhal Ches SnM
(Divi Division of Surgical, Orthopedic and Restora
510(k) Num
1 Page 1 of __
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.