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The Arthrex Compression FT Screws are intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:

• . Osteochondral fragments (talar vault, femoral condyle)
• . apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
• . cancellous fragments (talus)
• o Carpal, metacarpal, and small hand bone
• . tarsal and metatarsals
• . phalanges
• . Intra-articular fractures
• o ankle
• . proximal and distal humerus
• . proximal and distal radius
• . proximal and distal ulna
• . osteocondral fixation and fractures
• Osteochondritis Dissecans .
• . Fixation of fractures and osteotomies about the knee
• Oblique fractures of the fibula .
• . Reconstructive surgeries of the foot
• . malleolar fixation

The Arthrex Compression FT Screws are a family of titanium, cannulated, compression screws that are offered in a diameter range of 2.5 to 4.0mm, length range of 32 to 60mm, in a fully threaded design.

The provided text is a 510(k) summary for the Arthrex Compression FT Screws. It describes the device, its intended use, and its equivalence to predicate devices, but does not contain information related to the acceptance criteria of a study, the study itself, or its results in the context of device performance metrics often associated with AI/ML devices.

The document states that "Push-out, torque and compression testing were conducted to demonstrate that the proposed longer Arthrex Compression FT Screws perform statistically equivalent to the predicate." However, it does not provide:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study data or effect size.
• Standalone algorithm performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in submissions for devices that incorporate AI/Machine Learning, which this traditional orthopedic fixation device does not. The 510(k) for the Arthrex Compression FT Screws focuses on demonstrating substantial equivalence through engineering and biomechanical testing against predicate devices.

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The Arthrex Compression FT Screws is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:

• Osteochondral fragments (talar vault, femoral condyle)
• apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
• cancellous fragments (talus)
• Carpal, metacarpal, and small hand bone
• tarsal and metatarsals
• phalanges
• Intra-articular fractures
• ankle
• proximal and distal humerus
• proximal and distal radius
• proximal and distal ulna
• osteochondral fixation and fractures
• Osteochondritis Dissecans
• Fixation of fractures and osteotomies about the knee
• Oblique fractures of the fibula
• Reconstructive surgeries of the foot
• malleolar fixation

The Arthrex Compression FT Screws are a family of screws designed to provide fixation of fractures, osteotomies and arthrodesis. These titanium screws are cannulated with a tapering head. The screws will be offered in three diameters, 2.8mm, 3.7mm and 4.1mm, and will range in length from 8mm to 50mm.

The provided document is a 510(k) summary for a medical device, the Arthrex Compression FT Screws. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI/machine learning device.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical screw used for bone fixation. The "study" mentioned is mechanical testing (insertion, pull-out, and compression) to show that the physical properties of the proposed screws are comparable to predicate devices. This is a common requirement for Class II medical devices seeking 510(k) clearance, where safety and effectiveness are established by showing similarity to currently marketed devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/machine learning diagnostic device (e.g., performance metrics like sensitivity, specificity, AUC, human reader improvement, ground truth establishment) because this document is about a different type of medical device entirely, a bone fixation screw, and its clearance process does not involve AI performance evaluation.

The categories you requested are relevant for AI/ML device evaluations. The information present in the document is about mechanical testing and regulatory classification of a physical orthopedic implant.

If you have a document detailing a study for an AI/machine learning diagnostic device, please provide that, and I would be happy to describe its acceptance criteria and study details.

Ask a specific question about this device