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The PAO cortical screws are intended to refixate the acetabular fragment to the ilium, after Periacetabular osteotomy.

The PAO cortical screws are implantable devices for acetabular refixation after a Periacetabular osteotomy. They are provided sterile and single-packaged, for single use only. The PAO cortical screws are designed in two different sizes (Ø3.5mm and Ø4.5mm), both available in different working lengths (from 20mm to 140mm and from 50mm to 140mm respectively) to be suitable to treat all the desired population. The PAO Cortical Screws are made of Stainless Steel AISI 316 LVM according to ISO 5832-1.

This document pertains to the Medacta International SA PAO Cortical Screw, a medical device intended for refixating the acetabular fragment to the ilium after a Periacetabular osteotomy. As such, the information provided does not describe an AI/ML powered device, but rather a physical implantable device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical medical device (cortical screw) and not an AI/ML powered device, the "acceptance criteria" and "device performance" are related to mechanical and material properties, not diagnostic or predictive performance metrics. The document references performance testing according to ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated in the document. The performance tests (e.g., ASTM F543-17) would have involved a certain number of screws, but the specific quantity is not reported.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data involved in these non-clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable as this is a physical device and not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for mechanical properties is established by the specifications of the ASTM standard.

4. Adjudication Method for the Test Set:

• Not applicable for a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI/ML system being compared to human readers.

6. Standalone Performance Study (Algorithm only without Human-in-the-Loop):

• Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:

• For the non-clinical performance and material tests, the "ground truth" is defined by the specifications and methodologies outlined in the referenced international standards (e.g., ASTM F543-17, ISO 5832-1, European Pharmacopoeia §2.6.14, USP chapter , USP chapter ).

8. Sample Size for the Training Set:

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. There is no AI/ML algorithm involved, therefore no "training set" or corresponding ground truth establishment.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's substantial equivalence to predicate devices and its safety and effectiveness are supported by non-clinical studies focused on its mechanical performance and material properties. These studies include:

• Design Validation: A specific design validation for the PAO Cortical Screws was conducted.
• Performance Testing: This involved static tests on the PAO Cortical Screws according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The evaluation specifically included torsional properties, driving torque, axial pull-out strength, and self-tapping performance.
• Pyrogenicity Testing: Bacterial endotoxin tests were conducted according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter ), and pyrogen tests were performed according to USP chapter .

The document also states that the material used (Stainless Steel AISI 316 LVM according to ISO 5832-1) is shared with reference devices, addressing potential new safety and effectiveness questions related to material differences.

No clinical studies were conducted as part of this submission for substantial equivalence. The conclusion is that "the PAO cortical screws implants are substantially equivalent to the predicate devices" based on the provided non-clinical data, comparison of technological characteristics, and risk analysis.

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