(23 days)
The In2Bones USA LLC, CoLink® Plating System/CoLink® View Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the hand, wrist, foot and ankle in both pediatric and adult patients.
The In2Bones USA LLC, CoLink® Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.
The In2Bones CoLink® Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. Previous clearances include plates made from F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) material (K163293) and plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V ELI) materials (K172300). The PEEK material cleared previously was from the supplier, Evonik Industries. The scope of this submission is to modify the supplier of the PEEK material from Evonik Industries to Invibio Biomaterial Solutions. There is no design change to the implants and the instruments used with the system are identical. The Invibio PEEK material meets ASTM F 2026.
The provided text is related to a 510(k) premarket notification for a medical device called the "CoLink View Plating System." This document is an FDA clearance letter and a 510(k) summary, which focuses on establishing substantial equivalence to previously cleared devices rather than providing information about clinical studies or performance against acceptance criteria in the way typically seen for AI/ML-driven devices or diagnostic tools.
Therefore, most of the requested information about acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not available in this document. This submission is for a modification to a previously cleared device (changing a PEEK material supplier), and as such, it primarily relies on demonstrating that the new material is equivalent to the old one and to predicate devices, without requiring new clinical performance studies.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not specify performance acceptance criteria or report performance data in terms of clinical accuracy, sensitivity, specificity, etc. This is a clearance for a physical orthopedic implant system, not a diagnostic or AI-powered device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. No test set or patient data is mentioned as part of this submission. The submission is about a material change for an existing device.
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 Available. No ground truth establishment by experts is mentioned, as there are no test sets or clinical performance evaluations described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available. No adjudication method is mentioned.
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 Available. This information is irrelevant to this device. The CoLink® View Plating System is a metallic bone fixation appliance, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Available. This information is irrelevant to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available. No ground truth is discussed.
8. The sample size for the training set
- Not Available. No training data is mentioned.
9. How the ground truth for the training set was established
- Not Available. No training data or ground truth establishment is discussed.
Summary of available information from the document:
This submission, K182402, for the CoLink® View Plating System, describes a special 510(k) focused on modifying the supplier of the Poly Ether Ether Ketone (PEEK) material from Evonik Industries to Invibio Biomaterial Solutions. The key claim for substantial equivalence is that there are no design changes to the implants, the instruments are identical, and the new PEEK material meets ASTM F 2026, just like the previously cleared material.
The document explicitly states: "No additional mechanical testing or validations were required to establish substantial equivalence." This indicates that the regulatory cleared path for this particular modification did not necessitate new performance studies against acceptance criteria, but rather a demonstration of material equivalence.
§ 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.