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The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

The aap Cortical Screws 3.5, 4.5 are bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures or osteotomies. The screws can be used as non locking screws along with the aap LOQTEQ® System as well as lag screws, to hold together fragments of bone. The devices are made of Titanium alloy.

Variations of the aap Cortical Screw 3.5, 4.5:
• Cortical Screw 3.5, T15, self-tapping, Titanium
• Cortical Screw 4.5, T25, self-tapping, Titanium

Material:
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

Here's an analysis of the provided text regarding the acceptance criteria and study for the aap Cortical Screws 3.5, 4.5.

The document describes a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the "study" described is primarily focused on non-clinical mechanical testing to demonstrate that the new device performs similarly to established standards and the predicate device.

Description of Acceptance Criteria and the Study

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions "Tests performed" and "test results gained" for the mechanical properties of the screws, implying multiple samples were tested for each metric. However, specific numbers are not provided.
• Data Provenance: The tests are non-clinical, mechanical tests performed according to ASTM F543. The specific lab or country where these tests were conducted is not mentioned but would typically be part of the full submission, likely in Germany where aap Implantate AG is located. The data is thus prospective, as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is a non-clinical, mechanical testing study. The "ground truth" is established by the specified industry standard, ASTM F543. Therefore, no human experts were used to establish the "ground truth" for the test set in the way one would for clinical imaging interpretation. The experts involved would be those who developed and maintain the ASTM F543 standard, and the engineers/technicians performing the tests.

4. Adjudication method for the test set

• Not applicable as this is a non-clinical mechanical testing study. The results are quantitative measurements compared directly against the requirements of ASTM F543.

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 (bone screw) and not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a medical device (bone screw) and not an AI algorithm.

7. The type of ground truth used

• The ground truth for the performance assessment is based on established engineering and material science standards, specifically the requirements and methodologies outlined in ASTM F543 Standard Specification for Metallic Medical Bone Screws. The "acceptance criteria" are derived directly from this standard (e.g., minimum acceptable values for Maximum Torque and Breaking Angle as given in Annex A5 of ASTM F543).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

• Not applicable. (See #8)

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