(182 days)
The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation). The LOQTEQ® Distal Lateral Femur Plate 4.5 System consists of: LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5
The provided text describes a medical device, the "aap LOQTEQ® Distal Lateral Femur Plate 4.5 System," and its non-clinical testing for safety and effectiveness. However, it does not include information about a study involving AI, human readers, or image interpretation. Therefore, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment for a test set cannot be filled from the provided document.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance similar to the predicate device (LCP® Distal Femur Plates of Synthes) | "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained." |
| Periprosthetic Screws fulfill relevant ASTM F543-07 requirements and pre-defined criteria | "The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses." |
| Overall safety and effectiveness | "The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." (This is a conclusion based on the tests.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of number of plates/screws or iterations. The description only mentions "Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use" and "Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07." These are likely conducted on a defined number of physical samples according to the standard, but the exact count isn't in the provided text.
- Data Provenance: Not specified. The tests are non-clinical, meaning they were conducted in a laboratory setting, not with human patient data.
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 study is a non-clinical mechanical test of a physical implant, not an AI or diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the physical properties measured against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3. This is not an AI or diagnostic study requiring adjudication of 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
- Not applicable. The provided document describes the mechanical testing of a medical implant, not an AI system or diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The document describes mechanical testing of a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Engineering Standards and Specifications: The "ground truth" for the mechanical tests is the pre-defined acceptance criteria based on established engineering standards (e.g., ASTM F543-07) and comparison to the predicate device's mechanical performance.
8. The sample size for the training set
- Not applicable. There is no AI or machine learning component described, so no training set was used.
9. How the ground truth for the training set was established
- Not applicable. There is no AI or machine learning component described, so no training set or its ground truth establishment is relevant here.
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121494
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aap Implantate AG ααρ LOQTEQ® Distal Lateral Femur Plate 4.5 System
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany | NOV 1 9 2012 |
|---|---|---|
| Company Contact: | Dipl.-Ing. Marc SeegersPhone:+49-30-750-19-192Fax: +49-30-750-19-111 | |
| Date | May 9, 2012 | |
| Trade Name: | aap LOQTEQ® Distal Lateral Femur Plate 4.5 System | |
| Common Name: | Distal Lateral Femur Plate | |
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories - Class II and21 CFR 888.3040 Smooth or threaded metallic bone fixation fas-tener - Class II | |
| Device Product Code andPanel Code: | Orthopedics/87/ HRS: Plate, Fixation, BoneOrthopedics/87/ HWC: Screw, Fixation, Bone | |
| Predicate device: | LCP® Distal Femur Plates of Synthes (USA) with premarket noti-fication no. K062564 (OCT 19, 2006). | |
| Device Description: | Bone plates and screws are used for fixation of bone fragments,i.e., for treatment of bone fractures and other bone injuries.Bone plates are fixed by the use of bone screws. Bone platesand bone screws are implants. If the plates are used in conjunc-tion with locking screws, a so called internal fixator will be real-ized (internal fixation).The LOQTEQ® Distal Lateral Femur Plate 4.5 System consists of:LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5 | |
| Material: | Plates and Screws are made of Ti6Al4V (ASTM F136or ISO 5832-3) |
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aap Implantate AG
aop LOQTEQ® Distal Lateral Femur Plate 4.5 Syst
Indications: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures; fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur Substantial Equivalence The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use.
Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the effectiveness and safety of the device.
Summary of Non-clinical tests:
Type of test:
Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07
Assessment of test results:
Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 19, 2012
aap Implantate AG % Mr. Marc Seegers Regulatory Affairs Specialist Lorenzweg 5 D-12099 Berlin,Germany
Re: K121494
Trade/Device Name: app LOQTEO® Distal Lateral Femur Plate 4.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: October 26, 2012 Received: October 31, 2012
Dear Mr. Seegers:
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
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Page 2 - Mr. Marc Seegers
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/AboutFDA/CentersOffices/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/ResourcesforYou/Industry/default.htm.
Sincerely vours. Erin I. Keith Mark N. Melkerson Director
Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Traditional Premarket Notification oop Implantate AG oop LOQTEQ® Distal Lateral Femur Plate 4.5 System Section 4 Indications for Use Statement
4. Indications for Use Statement
12/444 510(k) Number (if known):
Device Name: LOQTEQ® Distal Lateral Femur Plate 4.5 System
Indications for Use:
The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for:
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Younle
(Division Sign-Off).
Division of Orthopedic Devices
510(k) Number K121494
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.