(77 days)
CoLink® 2 Plating System -
The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
CoLink® Afx Plating System -
The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.
The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.
This looks like a 510(k) premarket notification for a medical device, specifically the CoLink Plating System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting the results of clinical performance studies of an AI/ML device.
Therefore, many of the requested categories for a study proving device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. This submission primarily relies on mechanical performance testing and a comparison of materials, geometry, and indications for use to predicate devices.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a bone fixation system and not an AI/ML device, the "acceptance criteria" are not related to diagnostic performance metrics but rather to mechanical properties and substantial equivalence to predicate devices. The document refers to existing ASTM standards for testing.
| Acceptance Criteria (Implicit for mechanical devices based on predicate equivalence) | Reported Device Performance |
|---|---|
| Mechanical performance for plates (e.g., bending strength) per ASTM F382 (consistent with predicate devices). | A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. (Implies performance is comparable and acceptable). |
| Mechanical performance for screws (e.g., axial pullout, torque capacity, insertion torque) per ASTM F543 (consistent with predicate devices). | A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. (Implies performance is comparable and acceptable). |
| Sterilization, biocompatibility, shelf life, and pyrogenicity (consistent with predicate devices). | The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot. (Implies compliance with established validations and testing). |
| MR environment compatibility, including RF induced heating (consistent with predicate devices). | An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. (Implies acceptable MR compatibility). |
| Overall substantial equivalence in indications, materials, and geometry to predicate devices. | The subject CoLink® Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry. (This is the overarching conclusion of the submission, demonstrating all criteria for substantial equivalence were met). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification (510(k)) where substantial equivalence is demonstrated primarily through mechanical testing and comparison to predicate devices, not through a clinical "test set" of patient data as would be used for an AI/ML device.
- Sample Size: Not applicable in the context of this 510(k). The "samples" would be physical devices subjected to mechanical stress tests. The document doesn't specify the number of devices tested for each mechanical property, but rather refers to rationales and existing validations.
- Data Provenance: Not applicable. The data is from mechanical testing of the device components.
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)
Not applicable. There is no "ground truth" establishment by medical experts in this type of submission. The ground truth for mechanical performance is established by adherence to engineering standards (ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert interpretation.
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 bone fixation system, not an AI-assisted diagnostic tool.
6. 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Adherence to recognized mechanical testing standards (e.g., ASTM F382 for bending, ASTM F543 for screws).
- Demonstration of substantial equivalence in materials, design, and intended use to predicate devices that have already been cleared by the FDA and are presumed safe and effective.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.