(119 days)
The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.
The In2Bones CoLink™ View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.
This document describes a 510(k) premarket notification for a medical device, the In2Bones USA LLC, CoLink™ View Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials for de novo devices. Therefore, the information provided in the document is primarily related to mechanical testing and material compatibility, not the clinical performance or diagnostic capabilities of an AI-powered device.
Based on the provided text, it is not possible to provide the requested information about acceptance criteria and a study proving a device meets them, specifically regarding AI performance metrics. The document describes a traditional orthopedic implant (plating system) and the performance testing mentioned is mechanical and material-based, not related to AI or diagnostic accuracy.
Here's why the requested information cannot be extracted from this document, along with an explanation of what is present:
What the document is about:
- Device Type: The CoLink™ View Plating System is a system of plates and screws used for orthopedic fixation (e.g., treating fractures, fusions) in small bones of the hand, wrist, foot, and ankle.
- Regulatory Pathway: This is a 510(k) submission, meaning the manufacturer is demonstrating that its new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This pathway is for devices that are not significantly different from devices already on the market.
- Performance Testing Mentioned:
- Mechanical Testing: Four-point bend testing per ASTM F382-14 was performed to show the subject plates are mechanically equivalent to predicate plates.
- Biocompatibility Testing: Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity (i.e., that the materials are not harmful to the body).
- Conclusion: The device was determined to be substantially equivalent to the predicate devices based on indications, materials, geometry, and the mentioned performance testing.
Why the requested AI-related information is NOT in this document:
The provided text discusses the regulatory approval for a physical medical device (orthopedic plates and screws), not an AI/ML-driven diagnostic or assistive software. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI performance (like sensitivity, specificity, human reader improvement, ground truth establishment) are entirely irrelevant to this document.
To directly address your prompts:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for this device): Implied criteria are substantial equivalence to predicate devices in terms of indications, materials, geometry, and mechanical performance (e.g., meeting or exceeding certain bend strength thresholds per ASTM F382-14).
- Reported Device Performance: "the results show the subject plates to be substantially equivalent to the predicate plates." Specific numerical performance data from the mechanical tests (e.g., actual bend strength values) are not provided in this summary.
- No AI-related metrics as this is not an AI device.
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Sample size used for the test set and the data provenance:
- For mechanical testing, the "sample size" would refer to the number of physical plates tested. This information is not detailed in the summary.
- Data provenance is not applicable as this is not a study involving patient data for AI development or validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no diagnostic "ground truth" to establish for an orthopedic implant.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human reading or diagnostic assessment described for this device.
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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 not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is its mechanical integrity and biocompatibility, typically established through standardized physical tests and material science, not clinical outcomes in the way an AI diagnostic would be.
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The sample size for the training set:
- Not applicable. There is no AI training set.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory filing for a traditional medical device (orthopedic hardware), not an AI-powered one. Therefore, the questions related to AI-specific performance criteria and study methodologies cannot be answered from this text.
§ 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.