(88 days)
For fracture fixation of small bones and small bone fragments including odontoid fractures.
The AIS Odontoid Fracture Fracture Fixation System is comprised of screws and instruments. The 4.0mm cortical screws are either a fully-threaded or partially threaded. They are offered in various lengths and will be non-sterile. The screws are manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3.
This document is a 510(k) premarket notification summary for the AIS Odontoid Fracture Fixation System. It describes a new medical device and its equivalence to previously cleared devices. However, this type of document focuses on establishing substantial equivalence through non-clinical performance data (mechanical testing) rather than clinical studies of a device's performance in humans, especially for AI/algorithm-based devices.
Therefore, most of the requested information regarding acceptance criteria, device performance from clinical studies, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies, is not applicable or available within this provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical Performance (Mechanical Testing): | |
| Static Testing per ASTM F543 | "meets or exceeds the performance of the predicate devices" |
| Static and Dynamic Cantilever Testing per ASTM F2193 | "meets or exceeds the performance of the predicate devices" |
| Clinical Performance (regarding AI/algorithm): | Not applicable/Available |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Available. This document describes mechanical testing of a physical implant, not an AI/algorithm. Sample sizes would refer to the number of implants tested in a lab, not 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/Available. Ground truth in this context would relate to the physical properties measured in mechanical tests, not expert interpretation of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Available. Adjudication methods are relevant for human interpretation tasks, not mechanical testing.
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/Available. This document is for a physical orthopedic implant, not an AI/algorithm-based diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Available. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Mechanical Testing: The "ground truth" for the mechanical tests (Static Testing per ASTM F543 and Static and Dynamic Cantilever Testing per ASTM F2193) would be defined by the standard specifications and performance requirements outlined in those ASTM standards and the performance of the predicate devices. These are engineering standards measuring physical properties.
8. The sample size for the training set
- Not applicable/Available. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable/Available. This device does not involve a machine learning training set or ground truth establishment in that sense.
Summary of what the document does describe:
The document focuses on establishing substantial equivalence for the AIS Odontoid Fracture Fixation System to predicate devices through non-clinical performance testing (mechanical testing). The acceptance criteria for these tests were that the subject device "meets or exceeds the performance of the predicate devices" when evaluated according to ASTM F543 (Static Testing) and ASTM F2193 (Static and Dynamic Cantilever Testing). The results showed that this criterion was met. This approach is standard for demonstrating the safety and effectiveness of a physical implant by ensuring it performs mechanically at least as well as existing, cleared devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a way that suggests unity and connection. The profiles are black and are set against a white background. Encircling the profiles are the words "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
Aesculap Implant Systems, Incorporated Ms. Lisa M. Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
December 19, 2014
Re: K142707
Trade/Device Name: AIS Odontoid Fracture Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 18, 2014 Received: September 22, 2014
Dear Ms. Lisa M Boyle:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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I. REQUIRED STATEMENTS
Page 1 of 1
A. INDICATIONS FOR USE STATEMENT
510(k) Number:_ K142707
Device Name: Aesculap Implant Systems (AIS): Odontoid Fracture Fixation System
Indications for Use:
For fracture fixation of small bones and small bone fragments including odontoid fractures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X == and/or Over-the-Counter Use _____________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap Implant Systems (AIS), LLC. Odontoid Fracture Fixation System
November 12, 2014
| COMPANY: | Aesculap®Implant Systems (AIS), LLC.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311 |
|---|---|
| CONTACT: | Lisa M. Boyle800-258-1946 (phone)610-791-6882 (fax) |
| TRADE NAME: | AIS Odontoid Fracture Fixation System |
| COMMON NAME: | Screw, Fixation, Bone |
| CLASSIFICATION NAME: | Smooth or Threaded Metallic Bone Fixation Fastener |
| REGULATION NUMBER: | 21 CFR 888.3040 |
| PRODUCT CODE: | HWC |
| DEVICE CLASS: | Class II |
PURPOSE FOR PREMARKET NOTIFICATION
The submission expands the indications for use of the Aesculap Titanium Alloy Bone Screws cleared under K970549.
DEVICE DESCRIPTION
The AIS Odontoid Fracture Fracture Fixation System is comprised of screws and instruments. The 4.0mm cortical screws are either a fully-threaded or partially threaded. They are offered in various lengths and will be non-sterile. The screws are manufactured from titanium alloy (Ti6Al4V) per ISO 5832/3.
INDICATIONS FOR USE
For fracture fixation of small bone fragments including odontoid fractures.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)
As is established in this submission, the AIS Odontoid Fracture Fixation System is substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics
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Page 2 of 2
to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
PERFORMANCE DATA
Non-clinical testing was performed to demonstrate that the AIS Odontoid Fracture Fixation System is substantially equivalent to other predicate devices. The following testing was performed:
- . Static Testing per ASTMF543
- . Static and Dynamic Cantilever Testing per ASTM F2193
The results showed that the subject AIS Odontoid Fracture Fixation System meets or exceeds the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
PREDICATE DEVICE
§ 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.