(71 days)
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.
The AOS External Fixation System is an external fixation device comprised of rods, rod-to-rod clamps, pin-to-rod clamps and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and carbon fiber connector rods. The AOS External Fixation system is a non-sterile single use fixation device. The rod-to-rod clamps are designed to clamp to the 9.5mm carbon fiber rod and connect two rods together. The rod-to-pin clamps are designed to clamp to the 9.5mm carbon fiber rod and to the 5.0mm stainless steel half pins and the 5.0mm shaft on the 6.0mm center threaded pin. The stainless steel threaded half pins are 5mm in diameter and in lengths of 180mm and 210mm. The stainless steel thread center pins have a 6.0mm thread diameter, 5.0mm shaft diameter and are 280mm in length. The 5.0mm threaded half pin and the center threaded pins have twist flutes so that they are self-drilling. The connecting rods are carbon fiber reinforced plastic rods with an overall diameter of 9.5mm and are in length of 250mm, 300mm and 400mm.
The provided document is a 510(k) summary for the AOS External Fixation System. It does not describe a study that uses acceptance criteria to prove device performance in a way that aligns with the questions asked, which are typically relevant for AI/ML-based diagnostic or prognostic devices.
The AOS External Fixation System is a physical medical device, specifically an external fixation system for bone fractures. Its clearance is based on substantial equivalence to predicate devices, not on meeting specific performance metrics through a clinical or algorithmic study with defined acceptance criteria for accuracy, sensitivity, specificity, etc.
Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth, are not applicable to this type of device submission.
Here's an attempt to answer based on the provided document, highlighting what is not applicable:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similarity in design, geometry, construction, materials of construction, and indications for use to predicate devices. | The AOS External Fixation System is virtually identical in construct to the predicate devices (Stryker's Hoffman II Carbon Connecting Rods, K961916; Stryker's Hoffman III External Fixation System, K053472; and Stryker's Apex Fixation Pins, K011136). The materials are specified as titanium and stainless steel clamps, stainless steel fixation pins, and carbon fiber connector rods, which are consistent with the predicate devices. |
| Similar Indications for Use | "The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing." This is consistent with the predicate devices. |
| Safety and Effectiveness through Substantial Equivalence (General Controls) | FDA determined the device is substantially equivalent to legally marketed predicate devices. This implies it meets the general controls provisions of the Act for safety and effectiveness. |
| No mechanical testing necessary | "Since the devices are substantially equivalent in design, geometry, construction, materials of construction and indications it was determined that no mechanical testing was necessary to demonstrate substantial equivalence." |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. This was a substantial equivalence submission for a physical device, not a performance study of an algorithm on a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies (e.g., disease diagnosis) was not established for this submission. The "ground truth" for substantial equivalence is the existing, legally marketed predicate devices.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an external fixation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission is established by the functional characteristics, materials, and intended use of the predicate devices being legally marketed and deemed safe and effective. The device is shown to be substantially equivalent to these predicates.
- The sample size for the training set: Not applicable. There is no training set for a physical device.
- How the ground truth for the training set was established: Not applicable.
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APR 2 5 2008
510(k) SUMMARY
| SUBBMITTED BY: | Advanced Orthopaedic Solutions2444 205TH Street, Unit 5Torrance, CA 90501(310) 533-9966FAX (310) 533-9876 |
|---|---|
| 510(k) CONTACT PERSON: | Paul Doner, Vice President Operations |
| TRADE NAME: | AOS External Fixation System |
| COMMON NAME: | External Fixation |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple componentmetallic bone fixation appliances andaccessories. |
| DEVICE CODE: | KTT |
| SUBSTANTIALLYEQUIVALENT DEVICE: | Hoffman II External Fixation System (K053472)Apex Fixation Pins (K011136) |
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The AOS External Fixation System is an external fixation device comprised of rods, rod-torod clamps, pin-to-rod clamps and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery.
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury preclude the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.
The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and carbon fiber connector rods. The AOS External Fixation system is a non-sterile single use fixation device.
The rod-to-rod clamps are designed to clamp to the 9.5mm carbon fiber rod and connect two rods together. The rod-to-pin clamps are designed to clamp to the 9.5mm carbon fiber rod and to the 5.0mm stainless steel half pins and the 5.0mm shaft on the 6.0mm center threaded pin.
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The stainless steel threaded half pins are 5mm in diameter and in lengths of 180mm and 210mm. The stainless steel thread center pins have a 6.0mm thread diameter, 5.0mm shaft diameter and are 280mm in length. The 5.0mm threaded half pin and the center threaded pins have twist flutes so that they are self-drilling.
The connecting rods are carbon fiber reinforced plastic rods with an overall diameter of 9.5mm and are in length of 250mm, 300mm and 400mm.
The surgical technique used for the AOS Eternal Fixation System is a standard method used for external fixation and is same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, a pin inserter, a drill sheath and a 4.0mm calibrated drill.
SUBSTANTIAL EQUIVALENCE INFORMATION:
Substantial equivalence for the AOS External Fixation System is based on the similarity in indication for use, design features, operating principles and material of composition to Stryker's Hoffman II Carbon Connecting Rods, K961916, Stryker's Hoffman III External Fixation System, K053472 and Stryker's Apex Fixation Pins, K011136.
The construct of the AOS External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction and indications it was determined that no mechanical testing was necessary to demonstrate substantial equivalence.
INTENDED USE:
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment.
The AOS External Fixation System is intended to be non-weight bearing,
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Orthopaedic Solutions % Mr. Paul Doner Vice President Operations 2444 205th Street, Unit 5 Torrance, CA 90501
APR 2 5 2008
Re: K080408 Trade/Device Name: AOS External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JEC, JDW Dated: February 12, 2008 Received: February 14, 2008
Dear Mr. Doner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Paul Doner
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indication for Use Statement
| 510(k) Number (if known): | K080408 |
|---|---|
| --------------------------- | --------- |
Device Name: AOS External Fixation System
Indications for Use:
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment.
The AOS External Fixation System is intended to be non-weight bearing.
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)
Mitchel for mdm
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number.
Page 1 of 1
§ 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.