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510(k) Data Aggregation
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CoLink Cfx Plating System
The In2Bones USA LLC, CoLink® Cfx System is indicated for stabilization of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus in both pediatric and adult patients.
The In2Bones CoLink® Cfx Plating System is a system of plates and screws and surgical instruments intended for stabilization of calcaneal fractures and osteotomies. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Cfx Plating System.
The provided FDA document, K200762, is a 510(k) premarket notification for a medical device (CoLink® Cfx Plating System) that aims to demonstrate substantial equivalence to previously cleared predicate devices. This type of submission relies on comparisons to existing devices rather than new clinical effectiveness or performance studies against specific acceptance criteria.
Therefore, the document does not contain the information required to populate the fields in your request, as it does not describe a study proving the device meets specific acceptance criteria in the way you've outlined.
Here's why and what information is available (and what is not):
- Acceptance Criteria & Reported Performance: Not applicable. The document focuses on demonstrating similarity to already approved devices.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies: Not applicable. These relate to studies designed to evaluate a device's performance against a ground truth, which is not the purpose of this 510(k) submission.
- Training Set Sample Size & Ground Truth: Not applicable. This refers to AI/ML model development, which is not relevant to this mechanical implant device.
However, the document does provide the following relevant information about comparisons to predicate devices:
1. A table of acceptance criteria and the reported device performance
| Criteria Category | Description from Document (Implicit "Acceptance" is Substantial Equivalence) | Performance (as described in the document) |
|---|---|---|
| Indications for Use | "stabilization of fractures, revision procedures, osteotomies and reconstruction of the small bones in the foot and ankle including the calcaneus in both pediatric and adult patients." | "The CoLink® Cfx Plating System has similar indications to the CoLink® Plating System (K163293) and Silverback Gorilla Plating System (K182148)." |
| Material | (Implicitly, the material should be similar to predicates) | "made of Titanium Alloy" (Similar to K163293) |
| Design/Geometry | (Implicitly, the geometry should be similar or justified as equivalent) | "This submission is adding additional plates for the calcaneus that will be used with previously cleared screws." "similar in geometry." |
| Screws Compatibility | (Implicitly, compatibility with existing screws) | "The 3.5mm and 4.0mm screws initially cleared in the CoLink® Afx Plating System (K181113) can be used with the CoLink® Cfx Plating System." |
| Mechanical Performance | (Implicitly, performance demonstrating equivalence to predicates in applicable mechanical tests.) The document refers to ASTM F382 (Standard Specification for Metallic Bone Plates for External Skeletal Fixation) for four-point bend testing. | "No additional mechanical testing was required for the CoLink® Cfx Plating System. The 3.5mm and 4.0mm screws are identical to previously cleared screws and no new worst-case plates were added. Engineering analysis was conducted related to the CoLink® Plating four-point bend testing performed per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates." |
| Sterilization | (Implicitly, the sterilization method should be validated or demonstrated to be covered by previous validations.) | "not a worst case for sterilization...was adopted into the previous validations for the CoLink® Afx System (K181113)." |
| Biocompatibility | (Implicitly, the device should be biocompatible or demonstrated to be covered by previous validations.) | "not a worst case for...biocompatibility...was adopted into the previous validations for the CoLink® Afx System (K181113)." |
| Shelf Life | (Implicitly, the shelf life should be validated or demonstrated to be covered by previous validations.) | "not a worst case for...shelf life...was adopted into the previous validations for the CoLink® Afx System (K181113)." |
| Pyrogenicity | (Implicitly, the device should be non-pyrogenic or demonstrated to be covered by previous validations.) | "not a worst case for...pyrogenicity...was adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a 510(k) submission for a mechanical implant, not an AI/ML product or a product requiring a clinical "test set" in the context of effectiveness studies. The evaluations were based on engineering analysis and comparison to predicate devices, not patient data sets.
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. No ground truth established by experts for a test set is mentioned or required for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process is described.
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 mechanical 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 mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the FDA's determination of substantial equivalence based on the provided engineering analysis and comparison to predicate devices.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI/ML product that uses a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
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