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

The Asnis® III Cannulated Screw System, previously cleared in K000080, K024060, 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. Screws are made of stainless steel and titanium alloy.
The subject of this bundled traditional submission is to introduce minor design specification changes; MRI Labeling, shelf-life update of existing package to 10 years, and re-branding Ø6.5/8.0 mm long screws (130-180 mm to Asnis® PRO Cannulated Screw System) to the Asnis® III Cannulated Screw System, cleared in K000080 and K024060 and to introduce a new system Asnis® PRO Cannulated Screw System.

The provided document is a 510(k) Summary for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. It outlines the reasons for the submission and compares the new devices to predicates. However, it explicitly states there was no clinical data or clinical trials needed for this device submission. The changes made (minor design specification changes, MRI labeling, shelf-life update, and re-branding) did not create a new "worst case" scenario that would necessitate mechanical testing beyond what was already performed for the predicate device.

Therefore, the following information regarding acceptance criteria and studies to prove device performance cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: No new performance data is presented, as the document states "No mechanical testing was deemed necessary."
2. Sample size used for the test set and the data provenance: No new test set was used for mechanical performance, and no clinical data was collected.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring expert ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (screws), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance:

• Performance Data (Nonclinical):
  • "No mechanical testing was deemed necessary as the design modifications and the new system introduction do not create a new worst case. All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System (K024060), remain true and accurate."
  • 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 Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

In summary, this 510(k) submission relies on the substantial equivalence to its predicate devices and the existing non-clinical performance data for those predicates (K000080, K024060, and K140891), along with new MRI compatibility testing for the modified/new devices. No new trials or studies to establish performance against acceptance criteria in a traditional sense (e.g., diagnostic accuracy, clinical outcomes) were conducted or deemed necessary for this submission.

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