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The CoLink® NeoFuse MIS Plating System is a fusion plate indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a posterior compression screw and a fully threaded screw through the tibiotalar joint (example CoLag 6.7mm screw) are required for ankle fusion procedure.

The CoLink® NeoFuse MIS Plating System includes sterile fusion plates and screws for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus. The addition of a medial-lateral compression screw through the tibiotalar joint is required. These subject devices are a line extension of the CoLink® NeoFuse Plating System.

The provided text describes a medical device, the "CoLink® NeoFuse MIS Plating System," which is a fusion plate used for anterior fixation of ankle arthrodesis and fractures. This document is a 510(k) Pre-market Notification from the FDA, indicating a review of the device's substantial equivalence to existing legally marketed devices.

Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI-powered diagnostic device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various performance tests and comparisons.

The primary acceptance criteria for this type of medical device (a bone fixation system) revolve around:

• Mechanical Performance: The device must meet sufficient mechanical strength and fatigue properties to perform its intended function.
• Biocompatibility: The materials used must be safe for implantation in the human body.
• Sterility: The device must be sterile and maintain its sterility.
• Packaging Integrity: The packaging must protect the device and maintain sterility until use.
• Dimensional and Material Equivalence: The subject device's geometry, dimensions, and materials should be comparable to predicate devices.

Table of Performance (Based on provided text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide numerical sample sizes for mechanical testing (e.g., number of plates tested). It states "Testing was conducted per a modified ASTM F382 set up for the plates...". For biocompatibility, sterilization, and packaging, it refers to validation according to international standards (ISO, ANSI/AAMI), which implies that appropriate sample sizes were used as dictated by those standards for validation studies, but these specific numbers are not detailed in this summary.

There is no mention of data provenance (e.g., country of origin or retrospective/prospective nature) as this is not a clinical study involving human patient data, but rather performance testing of the device itself.

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)

This is not applicable. The device is a physical bone fixation system, not a diagnostic AI device requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" for the mechanical performance testing would be the physical properties and failure points observed during the standardized tests, compared against established engineering and regulatory benchmarks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need to be resolved. This document details engineering and performance testing, not clinical interpretation.

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 is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CoLink® NeoFuse MIS Plating System is a surgical implant, not an AI diagnostic tool.

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

This is not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance testing is based on:

• Standardized Test Methods: Adherence to and performance within established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72).
• Predicate Device Performance: The underlying assumption of substantial equivalence is that the predicate devices are safe and effective, and thus the subject device, performing comparably, is also considered safe and effective.

8. The sample size for the training set

This is not applicable. There is no "training set" as this device is not an AI algorithm requiring machine learning.

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

This is not applicable for the same reason as above.

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The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

The provided text is a 510(k) summary for the NeoSpan® Compression Implant System, describing a medical device used for bone fixation. It does NOT contain any information about a study proving the device meets acceptance criteria for an AI/software-based medical device.

The document primarily focuses on demonstrating substantial equivalence of the physical implant system to previously cleared predicate devices through performance testing related to mechanical properties (e.g., static bending, fatigue bending, pull-out, corrosion) and biological/sterilization properties, not performance of an AI algorithm.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving an AI device meets those criteria, as the input document is about an implantable hardware device.

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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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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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