(79 days)
The AOS Small Fragment Plating System is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, including osteopenic bone.
The AOS Small Fragment Plating System consists of titanium plates in various configurations and sizes. The system includes non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
This document describes a 510(k) premarket notification for the "AOS Small Fragment Plating System."
It indicates that the device is substantially equivalent to legally marketed predicate devices based on indications for use, similar shape and design, and fundamental technology.
Here's the breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: - Four-point bend strength (based on ASTM F382-14) - Variable Angle Locking Mechanism strength (screw-plate interface) | Substantially Equivalent to Predicate Devices: - The AOS Small Fragment Plating System met the mechanical performance requirements tested, demonstrating substantial equivalence to the predicate devices in terms of four-point bend strength and variable angle locking mechanism strength. |
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 explicitly stated. The document mentions "comparative mechanical testing" but does not detail the number of samples tested for each device or test.
- Data Provenance: Not specified. The testing was reported by Advanced Orthopaedic Solutions, Inc., located in Torrance, CA, USA, but the origin of the data itself (e.g., specific lab, country) is not mentioned. The testing is likely prospective, as it was performed specifically for this 510(k) 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 device is a physical implant (plating system), not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The "ground truth" for this device's performance is established through mechanical testing against industry standards (ASTM F382-14) and comparison to predicate devices, rather than expert medical interpretation of data. Therefore, this question is not applicable in the typical sense for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in diagnostic studies. For mechanical testing, the results are objectively measured per a defined protocol.
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. This is a physical orthopedic implant system, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established through mechanical testing data demonstrating that it meets predefined physical and mechanical properties and performs comparably to the predicate devices. The ASTM F382-14 standard provides the benchmark for performance, and the predicate devices serve as the comparative ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The "training" for such devices involves adherence to engineering design principles and manufacturing quality control.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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December 10, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated (AOS) Mr. Mark Steinhauer Product Development Engineer 3203 Kashiwa Street Torrance, California 90505
Re: K152732 Trade/Device Name: AOS Small Fragment Plating 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, HTN Dated: October 2, 2015 Received: October 5, 2015
Dear Mr. Steinhauer:
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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| 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) | K152732 |
|---|---|
| Device Name | AOS Small Fragment Plating System |
| Indications for Use (Describe) | The AOS Small Fragment Plating System is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, including osteopenic bone. |
| 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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Image /page/3/Picture/0 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in a darker shade of blue and the "O" and "S" in a lighter shade of blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is aligned to the left.
5. TRADITIONAL 510(K) SUMMARY
| DATE PREPARED: | September 4, 2015 |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966 |
| CONTACT PERSON: | Mark SteinhauerAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966 |
| DEVICE NAME: | AOS Small Fragment Plating System |
| COMMON NAME: | Small Fragment Plate |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiplecomponent metallic bone fixation appliances andaccessories and 21 CFR 888.3040 Smooth/threadedmetallic bone fixation fastener. |
| DEVICE CODE: | HRS, HWC and HTN |
| SUBSTANTIALLYEQUIVALENT DEVICES: | Synthes Small Fragment Dynamic CompressionLocking (DCL) System (510(k): K000684, ClearedApril 28, 2000) and Synthes 2.7mm/3.5mm LCPDistal Fibula Plates (510(k): K073460, ClearedFebruary 21, 2008). |
| DEVICE DESCRIPTION: | The AOS Small Fragment Plating System consists oftitanium plates in various configurations and sizes.The system includes non-locking and variable anglelocking screws in diameters of 2.4mm, 2.7mm,3.5mm, and 4.0mm. The plate system also includes3.5mm headless compression screws. |
| INDICATIONS FOR USE: | The AOS Small Fragment Plating System is intendedto be used for fixations of fractures, osteotomies, andnon-unions of the clavicle, scapula, olecranon,humerus, radius, ulna, pelvis, distal tibia, fibula,including osteopenic bone. |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantialequivalence of the AOS Small Fragment Plating |
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System to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology.
- PRECLINICAL TESTING: The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14 and a Variable Angle Locking Mechanism test to evaluate the screw-plate interface. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicates.
§ 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.