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The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

The purpose of this Special 510(k) is to add additional references to the LTJ Screws and Washer system. These new references are provided in titanium alloy compliant with ASTM F136 and have the same design and dimensions as the cleared LTJ Screws and Washer provided in stainless steel alloy compliant with ASTM F138. The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. The headless implants can be associated to an LTJ diameter 8 mm Washer. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.

I am sorry, but the provided text only contains regulatory information about AzurMeds Inc.'s LTJ Screws and Washer, including its classification, indications for use, and a comparison to predicate devices. It mentions that "Mechanical testing was performed under ASTM F543 requirements" and that "These tests showed the subject device to be substantially equivalent in terms of performance to the predicate LTJ Screws and Washer (K200987)."

However, the document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods. Therefore, I cannot generate the requested table and information about the device's performance against acceptance criteria.

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The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include:

Fractures and Osteotomies

• · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
• · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
• · Talar fractures
• · Ankle fractures
• Navicular fractures
• · Fractures of the fibula, malleolus, and calcaneus
• · Metatarsal and phalangeal osteotomies
• · Weil osteotomy
• · Calcaneal osteotomy

Hallux Valgus Correction

• · Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
• Interphalangeal (IP) arthrodesis
• · Proximal, midshaft, or distal osteotomy
• Lapidus arthrodesis

Arthrodesis/Deformity Correction

• 1st MTP arthrodesis
• Metatarsal deformity correction
• · Tarsometatarsal joint arthrodesis
• · Naviculocuneiform joint arthrodesis
• · Talonavicular arthrodesis
• Subtalar joint arthrodesis
• · Triple arthrodesis
• Medial column arthrodesis
• Subtalar joint distraction arthrodesis
• · Ankle arthrodesis
• · Lateralizing calcaneal osteotomy
• Lateral column lengthening
• · Hammertoe

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

• Medial and lateral column
• · Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including: fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sizedmatched washers are also available.

The provided document is a 510(k) summary for the Paragon 28 Monster® Screw System. This document DOES NOT contain information regarding acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML device performance.

Instead, it's a regulatory submission for a medical device (bone fixation screws) demonstrating substantial equivalence to previously marketed predicate devices. The "studies" mentioned are preclinical tests (engineering analysis, torsional, pullout, insertion/removal evaluations, sterilization validations) to show that modifications to the screws do not adversely affect performance compared to the predicate devices.

Therefore, I cannot fulfill your request as the information requested is not present in the provided text.

Here's a breakdown of why this document doesn't fit your request:

• Acceptance Criteria for AI/ML Performance: Not applicable. This is a traditional medical device (hardware).
• Study Proving Device Meets Acceptance Criteria (AI/ML): Not applicable. The "studies" are mechanical and material tests for screws, not AI/ML performance evaluations.
• Table of Acceptance Criteria and Reported Device Performance: Not applicable for AI/ML.
• Sample Size for Test Set and Data Provenance: Not applicable for AI/ML.
• Number of Experts for Ground Truth and Qualifications: Not applicable for AI/ML.
• Adjudication Method: Not applicable for AI/ML.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. There are no human readers or AI assistance.
• Standalone (algorithm only) Performance: Not applicable.
• Type of Ground Truth Used: Not applicable for AI/ML. (For the screws, the "ground truth" would be the established mechanical properties and safety profiles of predicate devices).
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable. This device does not use a training set in the AI/ML sense.

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The Field Orthopaedics Micro Screw System consists of the following kits with the following indications:

The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.

The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.

The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.

The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.

The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.

Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).

All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).

The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The provided text describes the 510(k) summary for the Field Orthopaedics Micro Screw System and does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/ML device.

The document discusses the mechanical performance of a physical medical device (screws, pins, and K-wires for bone fixation) and compares it to predicate devices based on:

• Mechanical testing: Torsional strength, maximum torque to drive-in and remove screws, and pull-out force, as per ASTM F543.
• Theoretical engineering analyses.
• Simulated surgeon-user testing.

It concludes that the device possesses greater strength than predicate devices and meets the strength requirements for solid screws (ASTM F543).

Therefore, I cannot extract the requested information (such as acceptance criteria table with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for AI/ML models) because this document is about the regulatory submission for a physical orthopedic implant system, not a software/AI/ML medical device.

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The Monster BITE Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

The Monster BITE Screw System™ includes snap-off, threaded bone screws offered in 2.0mm and 2.7mm diameters having overall lengths from 8 to 24mm.

Based on the provided FDA 510(k) summary, the device is the "Monster BITE Screw System™". This document is a premarket notification for a medical device and, as such, does not contain the detailed study data typically associated with clinical performance or AI algorithm validation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving clinical efficacy or the device's ability to meet specific performance criteria through empirical studies with clinical endpoints like an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study data for performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document because:

• This is a traditional medical device (metallic bone fixation fastener), not an AI/ML-driven device.
• The demonstration of substantial equivalence relies on material, design, and mechanical performance comparisons to predicate devices, not clinical performance metrics or AI algorithm accuracy.

The document does mention "Performance Data" but clarifies that it refers to theoretical comparisons of torsion and pullout strength along with insertion/removal torque testing per ASTM F543, demonstrating substantial mechanical equivalence to predicate devices, not clinical outcomes in patients or diagnostic accuracy.

In summary, the provided text does not contain the information needed to answer the prompt from the perspective of an AI/ML device's acceptance criteria and performance study because it describes a mechanical bone fixation device applying for 510(k) clearance based on substantial equivalence to existing devices.

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