(328 days)
Not Found
No
The summary describes a mechanical bone plate system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
No
The device, the AOS Clavicle Plate System, is an orthopedic implant used for fixation of bones, which is generally considered a surgical or interventional device rather than a therapeutic device in the sense of delivering therapy (e.g., drug delivery, radiation therapy, or other non-invasive treatments). Its primary function is mechanical support.
No
The device is described as a "Plate System" for "fixation for fractures, fusions, or osteotomies for the clavicle," indicating it is a surgical implant designed for treatment, not diagnosis. It does not mention any diagnostic functions, processing of medical images, or AI/ML components for analysis.
No
The device description explicitly states it consists of bone plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The AOS Clavicle Plate System is a system of bone plates and screws designed for surgical implantation to fix fractures, fusions, or osteotomies of the clavicle bone.
- Intended Use: The intended use is for providing fixation for bone procedures, not for analyzing biological specimens.
The description clearly indicates a surgical implant used directly on the bone, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The AOS Clavicle Plate system consists of bone plates and screws for fractures, fusions, and osteotomies of the clavicle bone. The bone plates are pre-shaped to fit the curves and angles of the clavicle and are provided in small, medium and large sizes. The plate accepts both locking and nonlocking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AOS Clavicle System was subjected to static and dynamic 4-point bend testing in accordance with ASTM F382, Standard Specification and Test Method for Metallic Bone Plates. The results demonstrate that the subject device is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K012655, K063460, K071715, K000684
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
OCT 2 4 2011
.
OS
ADVANCED ORTHOPAEDIC SOLUTIONS
| 5. TRADITIONAL 510(K) SUMMARY | |
|---|---|
| DATE PREPARED: | October 7, 2011 |
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc. |
| 386 Beech Avenue, Unit B6 | |
| Torrance, CA 90501 | |
| Phone: (310) 533-9966 | |
| CONTACT PERSON: | Julie Glendrange |
| Advanced Orthopaedic Solutions, Inc. | |
| 386 Beech Avenue, Unit B6 | |
| Torrance, CA 90501 | |
| Phone: (310) 533-9966 | |
| DEVICE NAME: | |
| COMMON NAME: | |
| CLASSIFICATION: | AOS Clavicle Plate System |
| Internal Fixation | |
| Class II, 21 CFR 888.3030 Single/multiple | |
| component metallic bone fixation appliances and | |
| accessories. | |
| DEVICE CODE: | |
| SECONDARY DEVICE CODE: | HRS |
| HWC | |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICE: | Acumed® Congruent Bone Plate System, Clavicle |
| Plate (510(k)s: K012655, Cleared Nov. 7, 2001; | |
| K063460, Cleared Dec. 7, 2006; and K071715, | |
| Cleared July 18, 2007.) | |
| Synthes® 3.5mm LCP Reconstruction Plate (510(k): | |
| K000684, Cleared April 28, 2000) | |
| DEVICE DESCRIPTION: | The AOS Clavicle Plate system consists of bone |
| plates and screws for fractures, fusions, and | |
| osteotomies of the clavicle bone. The bone plates | |
| are pre-shaped to fit the curves and angles of the | |
| clavicle and are provided in small, medium and large | |
| sizes. The plate accepts both locking and nonlocking | |
| screws. | |
| INDICATIONS FOR USE: | The AOS Clavicle Plate System provides fixation for |
| fractures, fusions, or osteotomies for the clavicle. | |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial |
| equivalence of the AOS Clavicle Plate System to the | |
| predicate device. The proposed plate has the same |
长10 3513
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K103512 Page 2/2
indications for use, is similar in shape and design, and has the same fundamental technology.
PRECLINICAL TESTING:
The AOS Clavicle System was subjected to static and dynamic 4-point bend testing in accordance with ASTM F382, Standard Specification and Test Method for Metallic Bone Plates. The results demonstrate that the subject device is 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 and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2011
Advanced Orthopaedic Solutions, Inc. % Julie Glendrange 386 Beech Avenue, Unit B6 Torrance, CA 90501
Re: K103513
Trade/Device Name: AOS Clavicle Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS/HWC Dated: October 7th, 2011 Received: October 11th, 2011
Dear Ms. Glendrange:
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
3
Page 2 - Ms. Julie Glendrange
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Sincerely yours,
Mark N. Mollerkson
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative 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, sans-serif font. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The logo is simple and professional, and it is likely used to represent a company that provides orthopaedic products or services.
4. INDICATIONS FOR USE STATEMENT
Traditional 510(k) Premarket Notification Indication for Use Statement AOS Clavicle Plate System
K103513 510(k) Number (if known):
Device Name: AOS Clavicle Plate System
Indications for Use:
The AOS Clavicle Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle.
Prescription Use: X AND/OR (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)
Mihail Chen for MCM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103513