(31 days)
The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
The aap LOQTEQ® Clavicle Plates 2.7/3.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Clavicle Plates 2.7/3.5 incorporate:
• LOQTEQ® Clavicle Shaft Plate (left and right)
• LOQTEQ® Superior Lateral Clavicle Plate (left and right)
• LOQTEQ® AcroPlate 3.5 (left and right)
to be used with
• LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping
• LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping
• Cortical Screw 2.5, small head,T8, self-tapping
• Cortical Screw 3.5, small head, self tapping
• Set of Instruments aap LOQTEQ® Clavicle Plates 2.7/3.5
The provided text describes a medical device, the "aap LOQTEQ® Clavicle Plates 2.7/3.5", which is a bone fixation appliance. The document is a 510(k) premarket notification summary from the FDA. It details the device's intended use, materials, and a comparison to predicate devices, supported by non-clinical performance data.
However, the provided text does not include information about AI/ML device performance, ground truth establishment for a test set, sample sizes for training or test sets in the context of AI, multi-reader multi-case studies, or standalone algorithm performance. The device is a traditional metallic bone fixation appliance, not an AI or imaging diagnostic tool.
Therefore, many of the requested categories related to AI modeling are not applicable to this document. I will focus on the acceptance criteria and study information that is present for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit for equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate devices in mechanical strength and durability, as assessed by customized 4-point-bending tests based on ASTM F382-99. | "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 substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." |
| Material | Complies with recognized standards for medical implants. | Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3). |
| Indications for Use | Consistent with predicate devices. | Intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle, and for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated in terms of number of plates or tests. The document refers to "customized 4-point-bending tests" and "test results gained," implying multiple tests were performed.
- Data provenance: Not specified in terms of country of origin. The test data is "Non-clinical," implying laboratory testing rather than human subject data. Retrospective or prospective is not applicable for non-clinical mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for this device's performance is objective mechanical testing (e.g., load-to-failure), not expert interpretation of outputs like in AI/imaging devices.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus processes for labeling ground truth in diagnostic studies, which is not relevant here. Mechanical tests have objective outcomes.
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
This question is not applicable. The device is a physical implant for bone fixation, not an AI or diagnostic imaging tool. MRMC studies are used for evaluating diagnostic performance with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation was based on objective mechanical testing outcomes from customized 4-point-bending tests according to ASTM F382-99, demonstrating strength, durability, and resistance to deformation under load. The ground truth for proving substantial equivalence was the performance of the predicate devices under similar testing conditions.
8. The sample size for the training set
This question is not applicable. This is a traditional mechanical device, not an AI model requiring a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for an AI model. For the mechanical testing, the "ground truth" (i.e., the expected performance benchmarks) was established by the performance characteristics of the predicate devices and the requirements of the ASTM F382-99 standard.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
aap Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 Berlin, Berlin D-12099 Germany
Re: K141823
Trade/Device Name: aap LOOTEO® Clavicle Plates 2.7/3.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 25, 2014 Received: July 7, 2014
Dear Dr. Christian Zietsch:
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
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Page 2 – Dr. Christian Zietsch
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K141823
Device Name: aap LOQTEQ® Clavicle Plates 2.7/3.5
Indications for Use:
The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.
The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
× Prescription Use Prescription Use
VOR Over-The
(21 CFR
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)
Elizabethīb%rank -S
Division of Orthopedic Devices
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Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin, Germany |
|---|---|
| Company Contact: | Dr. Christian ZietschPhone:+49-30-750-19-193Fax: +49-30-750-19-111 |
| Date | June/20/ 2014 |
| Trade Name: | aap LOQTEQ® Clavicle Plates 2.7/3.5 |
| Common Name: | Clavicle Plates 2.7/3.5 |
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories – Class II |
| Device Product Code andPanel Code: | Orthopedics/87/ HRS |
| Predicate device: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 are substantial-ly equivalent to Synthes (USA) 3.5 mm LCP Clavicle PlateSystem under the premarket notification K073186 (Dec 17,2007) and Synthes (USA) Clavicle Hook Plate under thepremarket notification K061753 (Aug 04, 2008). |
| Device Description: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 consists ofbone plates and bone screws, to be implanted by a sur-geon in order to achieve an internal fixation of bone frag-ments typically after fractures, osteotomies. If the platesare used in conjunction with locking screws, a so called in-ternal fixator will be realized (internal fixation).The aap LOQTEQ® Clavicle Plates 2.7/3.5 incorporate:• LOQTEQ® Clavicle Shaft Plate (left and right)• LOQTEQ® Superior Lateral Clavicle Plate (left andright)• LOQTEQ® AcroPlate 3.5 (left and right)to be used with• LOQTEQ® Cortical Screw 3.5, small head, T15,self-tapping• LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping• Cortical Screw 2.5, small head,T8, self-tapping• Cortical Screw 3.5, small head, self tapping• Set of Instruments aap LOQTEQ® Clavicle Plates2.7/3.5 |
Material:
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
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| Indications: | The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |
|---|---|
| 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 has been provided with this submission. | |
| Performance Data (Non-Clinical and / or Clinical): | Non-clinical tests have been performed and show the substantial equivalence of the device. |
| Summary of Non-clinical tests: | |
| Type of test: Customized 4-point-bending tests of bone plates, based on ASTM F382-99 | |
| 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 substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. | |
| Documentation regarding the mechanical testing to show the substantial equivalence has been provided with this submission. |
§ 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.