Search Results

The Arthrex Compression FT pins (1.9 mm) are intended for small bone fracture and osteotomy fixation in the hand, wrist, foot, ankle and knee.

The Arthrex Compression FT pins (2.4 mm) are intended for fixation of small bone fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:

• Osteochondral fragments
• Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
• Cancellous fragments
• 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 Pins are a family of solid, fully threaded, self-tapping, tapering head with and without a snap-off function designed to provide fixation of fractures, osteotomies and arthrodesis. The pins are offered in two diameters: 1.9 mm and 2.4 mm, and range in lengths from 10 mm to 50 mm. The pins are manufactured from Titanium Alloy, conforming to ASTM F136. The pins are sold sterile and non-sterile and are single use.

This document is a 510(k) summary for a medical device (Arthrex Compression FT Pins), which focuses on establishing substantial equivalence to previously cleared devices. It does not describe a study involving an AI/ML device for which the listed criteria (e.g., acceptance criteria for diagnostic performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies) would be relevant.

The performance data presented in this document pertains to mechanical and material testing of the physical pins, as well as biocompatibility and MRI compatibility. It is demonstrating that the new pins perform similarly to existing, cleared implants.

Therefore, I cannot provide the requested information because the provided text describes the regulatory clearance of a physical medical device (bone fixation pins), not an AI/ML powered device. The types of studies and acceptance criteria asked for (e.g., related to AI performance, human reader improvement, ground truth for AI models) are completely irrelevant to the information contained in this 510(k) summary.

Ask a specific question about this device

Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.

The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.

The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.

Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.

The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Cannulated Screws." It details the device's indications for use, technological characteristics, and performance data. However, this document does not contain information about an AI/ML-driven medical device, a study involving human readers or expert ground truth, or an AI algorithm's performance.

The "Performance Data" section discusses mechanical properties testing of the physical screws (torsional properties, driving torque, axial pullout strength, chemical and mechanical properties) against ASTM standards. It concludes that the device presents safety and efficacy in terms of its mechanical properties, but this pertains to the physical product, not a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided document does not pertain to such a device.

Ask a specific question about this device

The Arthrex Beveled FT Screws are indicated for fixation of bone reconstruction. Examples include:

• . Mono or Bi-Cortical osteotomies in the foot or hand
• . Distal or Proximal metatarsal or metacarpal osteotomies
• . Weil osteotomy
• . Fusion of the first metatarsophalangeal joint and interphalangeal joint
• . Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
• Akin type osteotomy
• Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus .
• . Calcaneus/cuboid arthrodesis
• Talar/navicular arthrodesis

The Arthrex Beveled FT Screws are fully threaded, cannulated screws with self-tapping, tapering head. The screws will be offered in three diameters: 3.5 mm, 4.0 mm and 4.5 mm, and will range in lengths from 12 mm to 60 mm. The screws are manufactured from Titanium Alloy, conforming to ASTM Standards F1472. The screws are sold sterile and non-sterile and are single use.

This document is a 510(k) Premarket Notification from the FDA regarding the Arthrex Beveled FT Screws. It's a regulatory clearance document, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria and study data for an AI/ML device.

The "Performance Data" section describes mechanical and biological testing of the bone screws, confirming their physical properties, MRI compatibility, and biocompatibility, not performance of a software algorithm.

To answer your request, I would need a document describing the regulatory clearance for an AI/ML medical device.

Ask a specific question about this device