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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 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 USA LLC, Fracture and Correction System plates and screws are intended to treat fractures, fusions, osteotomies and non-unions of the 5th metatarsal.

The Fracture and Correction System lag screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of various bones, including humerus, radius, ulna, tibia, calcaneus, fibula, and small bones (metatarsals, and phalanges).

The In2Bones CoLink® Plating System / CoLink® View Plating System / CoLink® Mini Plating System and Fracture and Correction System are previously cleared plate and screws systems. The scope of this submission is to add a new packaging system for the previously cleared screws. The screws are all made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V). The implants are MR conditional.

This document is a 510(k) Premarket Notification from the FDA regarding orthopedic plating and screw systems. It does not describe an AI/ML medical device or a study proving that an AI/ML device meets acceptance criteria. The document explicitly states that the submission's scope is to "add a new packaging system for the previously cleared screws" and mentions that the products are "identical in indications, materials and geometry." The "Performance Testing" section lists validations related to sterilization, packaging, shelf life, and biocompatibility, which are standard for physical medical devices, not AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an AI/ML device meets them from this document. The provided text does not contain any information related to AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies.

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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.

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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:

1. 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.

2. 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.

3. 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.

4. 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.

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 not an AI device.

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

   • Not applicable. This is not an AI algorithm.

7. 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.

8. The sample size for the training set:

   • Not applicable. There is no AI training set.

9. 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.

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