(16 days)
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metatsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).
All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
The aap Cortical Screws 1.5, self-tapping are bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures or osteotomies. The screws can be used along with the aap bone plate as well as lag screws, to hold together fragments of bone. The devices are made of Implant Stainless Steel or Titanium alloy.
Variations of the aap Cortical Screw 1.5, self-tapping
• Cortical Screw 1.5, self-tapping
• Cortical Screw 1.5, self-tapping, Titanium
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided FDA 510(k) summary for the "aap Cortical Screws 1.5, self-tapping" and "aap Cortical Screws 1.5, self-tapping, Titanium," the document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting performance data from a specific clinical or comprehensive validation study with explicit acceptance criteria as would be found for complex AI or diagnostic devices.
The information provided indicates that the device is a Class II medical device (Smooth or Threaded Metallic Bone Fixation Fastener) and the submission is a "special 510(k) premarket notification" to obtain clearance for the titanium version of an already cleared stainless steel screw.
Therefore, the answers to most of the questions related to clinical study performance and AI-specific criteria will be "Not applicable" or "Not specified in this document" because the regulatory pathway for this type of device (a bone screw) focuses on demonstrating equivalence in design, materials, and intended use, often through engineering rationale and comparison to existing devices, rather than a clinical trial with specific performance metrics like sensitivity/specificity or human reader improvement.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Clearance Basis: Substantial Equivalence to predicate device (aap Screw Implants K072411). | The new device has similar intended use, design, functionality, components, technological characteristics, and materials in use to the predicate. Engineering rationale supports substantial equivalence. |
| Material Equivalence: Made of Implant Stainless Steel (ASTM F138 or ISO 5832-1) or Ti6Al4V (ASTM F136 or ISO 5832-3). | Device is made of Implant Stainless Steel or Ti6Al4V, meeting specified ASTM/ISO standards. |
| Intended Use: Treat fractures of various bones as per AO Foundation standards. | Indications for Use align with fracture treatment across specified bones (clavicle, scapula, pelvis, long bones, small bones) following AO Principles. |
| No Spinal Fixation: Not intended for spinal fixation. | Explicitly stated: "All aap bone screws are for single use only and are not intended for any spinal fixation procedures." |
| Single Use Only: | Explicitly stated: "All aap bone screws are for single use only." |
| Safety and Effectiveness: Differences between subject and predicate devices are minor and do not raise new questions concerning safety and effectiveness. | Engineering rationale concludes that differences are minor and do not impact safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not specified in this document. The submission relies on "engineering rationale" and demonstration of substantial equivalence rather than a clinical test set with human subjects.
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 / Not specified in this document. This information would be relevant for devices that require expert interpretation or ground truth establishment (e.g., AI-powered diagnostic tools). For a bone screw, "ground truth" relates to its mechanical properties and biocompatibility, which are assessed through material testing and design specifications, not expert consensus on cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified in this document. Adjudication methods are typically used in clinical studies where multiple experts evaluate cases and a consensus or adjudication process is needed for ground truth. This is not relevant for the regulatory pathway described for this bone screw.
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 / No MRMC study was done. This device is a passive bone fixation fastener, not an AI software or diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Rationale and Material Standards: The "ground truth" for demonstrating the safety and effectiveness of this device primarily stems from established engineering principles, material standards (ASTM F136, F138; ISO 5832-1, 5832-3), and comparison to the predicate device's design and performance. There is no mention of patient outcomes data or pathology results being used as ground truth for this 510(k) submission.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a physical device and the concept of a "training set" and its ground truth is not relevant here.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2015
aap Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 Berlin, D-12099 DE Germany
Re: K150974
Trade/Device Name: aap Cortical Screws 1.5, Self-tapping, aap Cortical Screws 1.5, Selftapping, Titanium Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 10, 2015 Received: April 13, 2015
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 (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name aap Cortical Screws 1.5, self-tapping aap Cortical Screws 1.5, self-tapping, titanium
Indications for Use (Describe)
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metatsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).
All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 | April/10/ 2015 |
| Trade Name: | aap Cortical Screws 1.5, self-tappingaap Cortical Screws 1.5, self-tapping, titanium |
| Common Name: | Screw, fixation, bone |
| Classification Name andReference: | 21 CFR 888.3040 Smooth or threaded metallicbone fixation fastener - Class II |
| Device Product Code andPanel Code: | Orthopedics/87/HWC |
| Predicate device: | The aap Cortical Screw 1.5, self-tapping is substantiallyequivalent to aap Screw Implants under the premarket noti-fication K072411 (Mar 20, 2008). |
| Purpose of Submission | This special 510(k) premarket notification is submitted toobtain clearance for the aap Cortical Screws 1.5, self-tapping (titanium) |
| Device Description: | The aap Cortical Screws 1.5, self-tapping are bonescrews, to be implanted by a surgeon in order to achievean internal fixation of bone fragments typically after frac-tures or osteotomies. The screws can be used along withthe aap bone plate as well as lag screws, to hold togetherfragments of bone. The devices are made of Implant Stain-less Steel or Titanium alloy. |
| Variations of the aap Cortical Screw 1.5, self-tapping | |
| • Cortical Screw 1.5, self-tapping• Cortical Screw 1.5, self-tapping, Titanium | |
| Material: | Implants are made of Stainless Steel (ASTM F138 or ISO5832-1) or Ti6Al4V (ASTM F136 or ISO 5832-3) |
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| Indications: | The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). |
|---|---|
| All aap bone screws are for single use only and are not intended for any spinal fixation procedures. | |
| Substantial Equivalence Summary | The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components, technological characteristics and materials in use. |
| Documentation to show the substantial equivalence has been provided with this submission. | |
| Engineering rationale have been prepared and show the substantial equivalence of the device. | |
| Summary of Engineering rationale: | |
| Any differences between the subject devices and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.