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CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.

This document is a 510(k) Premarket Notification from the FDA regarding the "CREED™ Cannulated Screws." It is a premarket submission for a medical device and, as such, does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence of a new medical device (CREED™ Cannulated Screws) to a legally marketed predicate device (also CREED™ Cannulated Screws, K200291) based on mechanical performance and material characteristics, not on clinical outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria for diagnostic performance
• Study proving device meets acceptance criteria (in the context of diagnostic performance)
• Sample size for test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for training set
• How ground truth for training set was established

The "Performance Data" section explicitly states: "Static bending (ASTM F1264) test results were presented along with engineering rationale for other relevant measures." This indicates that the performance evaluation was based on mechanical testing, not clinical or diagnostic studies.

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CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, non-unions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREEDTM Cannulated Screws consists of subject components that will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed or headless compression. All screws are self-drilling and self-tapping. The screws are offered in configurations that include a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA-600 PEEK (ASTM F2026). A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.

This document is a 510(k) Premarket Notification for the CREED™ Cannulated Screws, a medical device for bone fixation. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria for an AI/ML device or a study proving its performance.

Therefore, I cannot provide the requested information about acceptance criteria or a study related to AI/ML device performance from the provided text. The document is for a traditional medical device (cannulated screws) and does not involve AI/ML.

Ask a specific question about this device