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The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixations, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.

The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, nonunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis® III Cannulated Screw System, previously cleared in K213199, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The subject of this bundled traditional submission is to clarify the indications to the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System, cleared in K213199 and to introduce a new washer to the Asnis® PRO Cannulated Screw System cleared in K213199.

The provided document is an FDA 510(k) clearance letter for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. This document focuses on the substantial equivalence of a medical device to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical or AI-based studies.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training data details) is not present in this type of regulatory submission.

The document explicitly states under "Performance Data (Nonclinical)":

• "No mechanical testing was deemed necessary as the new washers does not create a new worst case."
• "All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199), remain true and accurate. Static Cantilever Bending Test was performed according to ASTM F2193."
• "Tests performed to establish compatibility with a magnetic resonance environment...Magnetically Induced Displacement per ASTM F2052 Magnetically Induced Torque per ASTM F2213 RF Heating per ASTM F2182 Image Artifacts per ASTM F 2119"
• "Clinical data and conclusions were not needed for this device."

This indicates that the assessment for this device clearance relied on bench testing and comparison to existing data from a predicate device (K213199), rather than a clinical study evaluating diagnostic accuracy, reader performance, or AI algorithm performance as you've outlined in your request.

In summary, none of the specific details you requested regarding acceptance criteria based on a clinical study, sample sizes, expert adjudication, MRMC studies, or AI algorithm performance can be extracted from this 510(k) document because such a study was not conducted or required for this particular type of device clearance.

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The Asnis III Cannulated Screw System intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System. Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified. The material, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.

The provided text describes a Special 510(k) submission for modifications to the Asnis III Cannulated Screw System. This type of submission is for device modifications where "Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device." It does not contain information about an AI-powered medical device or studies related to AI performance.

Therefore, I cannot provide details on the specific points requested (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set sizes, or ground truth establishment for a training set) because the provided document is about a mechanical screw system modification, not an AI/software device that would typically involve such studies.

The document explicitly states:

• "This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System."
• "Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified."
• "Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device."

This indicates that the modifications are purely mechanical, and the "study" demonstrating performance is mechanical testing and analysis, which confirms comparability to the predicate device, rather than clinical trials or AI performance evaluations.

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Ask a specific question about this device