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The AIS Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The AIS Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent expulsion of the allograft, or impingement of the spinal cord.

The AIS Laminoplasty Plating System is an implant system comprised of various sizes of plates that are designed to fit anatomy of the elevated lamina. The plates have screw holes, which allow for attachment to the vertebral body and the allograft. The screws to be used with the plates are available in a 2mm length with various diameters and are designed to match the anatomical requirements. The AIS Laminoplasty Plating System is manufactured from Titanium/Titanium Alloy and will be provided non-sterile and or sterile.

The provided documentation describes a medical device, the "Aesculap Implant Systems Laminoplasty Plating System," which underwent a 510(k) premarket notification. This submission relies on performance data from in vitro testing rather than clinical studies or AI/algorithm performance. Therefore, many of the requested categories related to AI performance, human readers, sample sizes for AI, and ground truth establishment are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Performance: The device's performance was measured against the standards set by ASTM F2193 (for static and dynamic bending) and ASTM F543 (for screw pull-out). The submission states that the testing results demonstrate the device is "safe and effective comparable to other predicate systems currently on the market," implying that it met or exceeded the performance of these predicates under the specified tests. Specific numerical values for the acceptance criteria or the device's performance are not provided in this summary.

Regarding AI-specific questions (not applicable to this device submission):

• 2. Sample size used for the test set and the data provenance: Not applicable. This device relies on in vitro mechanical testing, not a data-driven algorithm with a "test set" of patient data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro mechanical testing is based on engineering principles and measurements rather than expert human interpretation of medical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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. No AI component.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component.
• 7. The type of ground truth used: For this device, the "ground truth" for demonstrating safety and effectiveness comes from the engineering principles and material science underlying the ASTM standards (F2193 and F543). The outcome measures are physical properties (e.g., bending strength, pull-out force) measured directly, rather than medical observations.
• 8. The sample size for the training set: Not applicable. No AI component.
• 9. How the ground truth for the training set was established: Not applicable. No AI component.

Summary of the Study and Device Approval:

The "study" in this context refers to the performance testing conducted according to recognized industry standards (ASTM F2193 and F543).

• Study Type: In vitro mechanical testing.
• Purpose: To demonstrate the mechanical safety and effectiveness of the AIS Laminoplasty Plating System.
• Methodology: The system underwent static bending, dynamic bending, and screw pull-out testing.
• Result: The testing reportedly demonstrated that the device is "safe and effective comparable to other predicate systems currently on the market." This comparison implies that the device performed equivalently to, or better than, legally marketed predicate devices that have established safety and effectiveness.
• Clinical Testing: No clinical testing was performed for this submission; the 510(k) relies solely on the in vitro performance data and substantial equivalence to predicates (AIS Laminoplasty Plating System (K090354) and Synthes AFS (K032534)) based on material, design, function, and intended use.

This 510(k) clearance (K103284) was granted based on the demonstration of substantial equivalence to predicate devices through in vitro performance testing, rather than through clinical trials or AI algorithm validation.

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