Search Results

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.

Ask a specific question about this device

The CoLink® NeoFuse Plating System is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia and talus.

The addition of a compression screw through the tibiotalar joint (example CoLag 6.7mm screw) is required.

The In2Bones CoLink® NeoFuse 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 part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink NeoFuse Plating System.

This is not an AI/ML device, so elements of the typical AI/ML acceptance criteria and study information are not applicable. The provided text describes a traditional medical device (metallic bone fixation system) and its regulatory clearance process, which focuses on demonstrating substantial equivalence to previously cleared predicate devices through performance testing and material comparisons.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device:

Device Name: CoLink® NeoFuse Plating System
510(k) Number: K213069

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of plates or screws tested. It refers to "testing conducted per a modified ASTM F382 set up" for plates. For biocompatibility, sterilization, packaging, and endotoxin tests, these are typically conducted on representative samples of the device and its components, but specific sample numbers are not provided.
• Data Provenance: Not explicitly stated, but typically, these types of performance tests are conducted in a laboratory setting (e.g., by the manufacturer or a contract testing facility) in support of regulatory submissions. This is not clinical data, so terms like "retrospective" or "prospective" do not apply.

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)

• N/A. This is a hardware device review, not an AI/ML diagnostic or prognostic device that relies on ground truth established by experts interpreting clinical data. Ground truth in this context refers to the validated performance of the physical device under various engineering tests. Expert involvement would be in the design, testing methodology, and interpretation of engineering data, rather than clinical interpretation.

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

• N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts evaluate ambiguous cases or results for AI/ML performance evaluation. This device's evaluation is based on objective engineering tests and material comparisons.

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

• N/A. No MRMC comparative effectiveness study was performed as this is not an AI/ML device designed to assist human readers.

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

• N/A. This is not an AI/ML algorithm. Its "performance" is assessed through physical and material testing, not through algorithmic output.

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

• Engineering Standards and Predicate Device Performance: The "ground truth" for this device's acceptance is based on its ability to meet established engineering standards (e.g., ASTM F382, ISO 10993-1, ISO 11137-2, ISO 11607-1, ANSI/AAMI ST72) and demonstrate "substantial equivalence" in mechanical properties, biocompatibility, sterilization, and function to previously cleared predicate devices. The performance of predicate devices against these standards serves as a benchmark.

8. The sample size for the training set

• N/A. This is not an AI/ML device, so there is no "training set."

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

• N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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.

Ask a specific question about this device