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The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.

The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.

The provided text is a 510(k) summary for the D CoLink® Sfx Implant System, a medical device used for temporary fixation and stabilization of bone fractures. It describes "performance testing" but explicitly states that no additional mechanical testing was required. This means the FDA cleared the device based on an "engineering analysis comparing the subject implants to legally marketed predicates" and not on specific acceptance criteria for performance met by a study of the device itself.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to a performance study that was not conducted for this specific device.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. The submission states: "No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates." This implies that the acceptance criteria for performance were met by the predicate devices, and the subject device was deemed substantially equivalent without direct performance testing against specific criteria.

2. Sample size used for the test set and the data provenance

This information is not available. No mechanical performance study was conducted for this device. The assessment was based on an engineering analysis comparing it to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not available. No performance study requiring expert ground truth was conducted.

4. Adjudication method for the test set

This information is not available. No performance study requiring adjudication was conducted.

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

This information is not applicable. This device is a bone fixation implant system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a bone fixation implant system, not an algorithm.

7. The type of ground truth used

This information is not available. No performance study requiring ground truth was conducted. The clearance was based on substantial equivalence to predicate devices, supported by an engineering analysis and non-mechanical validations.

8. The sample size for the training set

This information is not applicable. This device is a physical implant, not an AI model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable. This device is a physical implant, not an AI model requiring a training set.

Summary of what was reported regarding "Performance Testing":

The "Performance Testing" section primarily discusses non-mechanical validations and refers to an "engineering analysis" instead of direct performance testing for the subject device's mechanical properties.

• Validations and risk assessments were conducted for:
  • Sterilization (ISO 11137-2)
  • Biocompatibility (ISO 10993-1)
  • Packaging and shelf life (ISO 111607-1)
  • Pyrogenicity (ANSI-AAMI ST72)
• Bacterial endotoxin testing (LAL) is performed on each lot.

It's important to note that these are essential validations for medical devices but do not represent performance testing in the sense of functional mechanical performance criteria typically seen for AI/diagnostic devices or even some other classes of implants where specific performance benchmarks must be met by the device itself in a study. In this case, the decision was made on substantial equivalence, relying on the performance of the predicate devices and an engineering comparison.

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The In2Bones USA LLC, 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.

The In2Bones CoLink® Mini Plating System is a system of plates and screws and surgical instruments intended for stabilization of forefoot and midfoot fractures. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® Mini Plating System.

This document is a 510(k) premarket notification from In2Bones USA, LLC for their CoLink® Mini Plating System. The FDA's letter and the company's 510(k) Summary confirm that the device is a metallic bone fixation appliance used for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies, and reconstruction of small bones in the hand, wrist, foot, and ankle for both pediatric and adult patients.

However, the provided text does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device. The document is for a traditional medical device (metallic bone plates and screws), and the "Performance Testing" section explicitly states that "No additional mechanical testing was required for the CoLink® Mini Plating System." Instead, it relies on engineering analysis and comparison to previously cleared predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with defined acceptance criteria and human or algorithmic performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are not relevant to the type of device and submission described in the provided text. The "Conclusion" section within the 510(k) Summary explicitly states: "Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices." This highlights that the basis for clearance is substantial equivalence to existing devices, not a new performance study against specific acceptance criteria.

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