(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.
§ 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.