(68 days)
Open and closed fracture fixation, nonunion, precise control of bone segments location including angulation, rotation, translation, lengthening, and shortening. The External Fixator also aids correction of bone deformities or defects associated with fractures and other pathological conditions of bone. The limb function is preserved if the External Fixator is properly applied.
CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring). Part of external fixator aiding trophism in the correction of bone deformities/defects. Same physical design as predicate, except aesthetically and tactual more pleasing with improved impression of superior strength and safe mobility. Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%.
The CyberOrthology Carbon Fiber Composite Circular Fixation (CIRfix) Device (Half Ring) was evaluated against its predicate device, the Ilizarov External Fixation System (K962808). The study focused on demonstrating comparative performance rather than setting specific acceptance criteria for absolute performance.
Here's a breakdown of the information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document describes a comparative study, implying that the "acceptance criteria" were met by demonstrating superiority in certain mechanical tests compared to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (CyberOrthology CIRfix) |
|---|---|
| Mechanical Performance Equal or Superior to Predicate Device | 15%-20% superiority compared to the predicate device in comparative testing. Specific tests mentioned include: Compression Stiffness (ASTM F-1746), 3-Point Bending, Cantilever Bending, and Wire Pull-out Test. |
| Similar Indication for Use | Same as the predicate device: Part of external fixator aiding trophism in the correction of bone deformities/defects. |
| Similar Target Population | Same as the predicate device: Human of any gender and at the advanced walking age. |
| Material Properties | Radiolucent Carbon Fiber Composite utilizing Randomly orientated, pre-impregnated carbon strands resulting in a carbon fiber content of better than 62%. (Predicate features pre-determined fiber orientations and typically 55% carbon fiber content). |
| Sterility | Shipped non-sterile & device may be sterilized as required by any method. (Same as predicate). |
| Biocompatibility | Component is a non-invasive external device, not for implantation or contact with skin/soft tissues. (Same as predicate). |
| Mechanical Safety | Test procedures and requirements allow for appropriate rigidity and stability. (Same as predicate). |
| Chemical Safety | Indicated for use in clinical and common patient living environments, not exposed to harmful chemical elements. (Same as predicate). |
| Compatibility with other Devices | Compatible with all appropriate predicate devices. (Predicate compatible with specially designed frames, clamps, rods, couplings, pins, posts, bolts, washers, nuts, & others). |
2. Sample Size and Data Provenance
The document does not specify the precise sample size used for the comparative mechanical tests. It only states "Comparatively tested." The data provenance is not mentioned (e.g., country of origin) nor whether it was retrospective or prospective, but given it's a mechanical performance comparison, it would likely be laboratory-based testing.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the study described is a mechanical performance comparison of a medical device, not a study involving human interpretation of data where expert ground truth would be established (e.g., in medical image analysis).
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. MRMC Comparative Effectiveness Study
An MRMC (Multi Reader Multi Case) comparative effectiveness study was not conducted. The study described is a direct mechanical comparison of a new physical device against an existing physical device, not an evaluation of human reader performance with or without AI assistance.
6. Standalone Performance Study
A standalone performance study in the context of patient outcomes or clinical efficacy was not explicitly described for the CyberOrthology CIRfix. The "performance" described is a standalone mechanical performance comparison against a predicate device in a laboratory setting. The document highlights mechanical superiority of the new device (15-20% superiority in various tests) when compared to the predicate device.
7. Type of Ground Truth Used
The "ground truth" for this study was established through mechanical testing standards (e.g., ASTM F-1746 for Compression Stiffness) and direct comparison of measurable physical properties against a predicate device. This is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
§ 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.