(71 days)
The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip joint, nonunions and malunions, and fractures resulting from osteoporosis.
The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.
The provided text describes a medical device, the "AOS Retrograde Femoral Nail System," and its submission for 510(k) clearance. However, it does not contain a study that proves the device meets acceptance criteria in the way typically required for AI/ML-based medical devices (i.e., with performance metrics like sensitivity, specificity, or F1-score derived from clinical data).
Instead, this document describes a traditional 510(k) submission for a mechanical medical device (an intramedullary fixation rod). The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through preclinical mechanical testing.
Therefore, I will interpret "acceptance criteria" as meeting the performance of predicate devices in mechanical testing and "study" as the preclinical mechanical testing performed.
Here's an analysis based on the provided text, modified to fit the context of a mechanical medical device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Substantially equivalent mechanical properties to predicate devices, based on ASTM F384. | The AOS Retrograde Femoral Nails and accessories are substantially equivalent to the predicates based on comparative mechanical testing per a test based on ASTM F384. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of devices tested (sample size) for the preclinical mechanical testing. It mentions "The AOS Retrograde Femoral Nail System" was subjected to testing, implying a representative set.
- Data Provenance: The testing was preclinical (laboratory-based mechanical testing) and conducted by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA. This would be considered prospective, as the testing was done directly for this submission.
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)
This question is not applicable to preclinical mechanical testing. The "ground truth" for mechanical testing is established by standard engineering principles and test methods (e.g., ASTM F384), not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to preclinical mechanical testing. Adjudication methods are relevant for clinical studies where human interpretation or consensus is needed to establish ground truth or assess 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, mechanical implant (intramedullary nail), not an AI/ML-based diagnostic or assistive software. Therefore, there are no "human readers" or "AI assistance" in the context of this device's performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm or AI system. Its performance is assessed as a standalone mechanical product in a laboratory setting. The "performance" described refers to its physical characteristics and durability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by the standardized mechanical test methods (ASTM F384). The performance of the predicate devices under these conditions serves as the reference for substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no AI/ML algorithm involved, so there is no "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/ML algorithm.
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ANCED ORTHOPAEDIC SQLUTIONS
5. TRADITIONAL 510(K) SUMMARY
Internal Fixation
Rod
HSB
DATE PREPARED:
September 3, 2013
SUBMITTED BY:
Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: (310) 533-9966
CONTACT PERSON:
Allyson Parks Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance. CA 90501 Phone: (310) 533-9966
AOS Retrograde Femoral Nail System
DEVICE NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
DEVICE DESCRIPTION:
INDICATIONS FOR USE:
AOS Modular Femoral Nail System (510(k): K012190, Cleared September 24, 2001), Stryker T2 Supracondylar Nail System (510(k): K023267, Cleared December 11, 2002), and AOS Antegrade Femoral Nail System (510(k): K123569, Cleared May 24, 2013)
Class II, 21 CFR 888.3020 Intramedullary Fixation
The AOS Retrograde Femoral Nail System consists of Titanium Allov Rods. Screws and End Caps for femur fracture fixation.
The AOS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following: Open and closed femoral fractures, Pseudoarthrosis and correction osteotomy, Pathologic fractures, impending pathologic fractures, and tumor resections, Supracondylar fractures, including those with severe comminution and intraarticular extension, ipsilateral femur fractures, bone lengthening, fractures proximal to a total knee arthroplasty or prosthesis, fractures distal to a hip
SEP 10 2013
Page 5-1
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joint, nonunions and malunions, and fractures resulting from osteoporosis.
SUBSTANTIAL EQUIVALENCE: Information presented supports substantial equivalence of the AOS Retrograde Femoral Nail System to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, has the same fundamental technology and is made of the same material.
PRECLINICAL TESTING:
The AOS Retrograde Femoral Nail System was subjected to comparative mechanical testing per a test based on ASTM F384. The results demonstrate that the AOS Retrograde Femoral Nails and accessories are substantially equivalent to the predicates.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 10, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOod-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions. Incorporation Ms. Allyson Parks Regulatory Associate 386 Beech Avenue, Unit B6 Torrance, California 90501
Re: K132005
Trade/Device Name: AOS Retrograde Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 02, 2013 Reccived: July 03, 2013
Dear Ms. Parks:
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 10 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 docs 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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Allyson Parks
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 yours.
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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Image /page/4/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a bold, stylized font. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is all in black and the background is white.
4. INDICATIONS FOR USE STATEMENT
Traditional 510(k) Premarket Notification Indication for Use Statement AOS Retrograde Femoral Nail System
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AOS Retrograde Femoral Nail System
Indications for Use:
The AQS Retrograde Femoral Nail is intended for use in intramedullary fixation of fractures of the femur to include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondyiar fractures, including those with severe comminution and . intraarticular extension
- lpsilateral femur fractures .
- Bone lengthening .
- Fractures proximal to a total knee arthroplasty or prosthesis �
- Fractures distal to a hip joint .
- Nonunions and malunions ●
- Fractures resulting from osteoporosis .
AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 4-1
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.