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SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long 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cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long 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This 510(k) premarket notification for the SmartScrew II is a Special 510(k), meaning it is for a modification to a previously cleared device (the SmartScrew/NuGenFX Screw, K012001). As such, the submission focuses on demonstrating that the revised device is substantially equivalent to the predicate device, especially regarding the modification, rather than proving performance against novel acceptance criteria through extensive clinical studies like a de novo device might require.

Therefore, the provided document does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a new device would. Instead, the "study" is more accurately a comparison to the predicate device focusing on the impact of the design change.

Here's how to address your request based on the provided text, recognizing the nature of a Special 510(k):

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a Special 510(k) revolve around demonstrating that the modifications do not negatively impact the safety and effectiveness of the device and that it remains substantially equivalent to the predicate. The performance is assessed by comparing the new design feature (screw head) against the predicate.

Study Information (Based on Special 510(k) Context)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Sample Size: Not explicitly stated. For a Special 510(k) focused on a design change like this, the "test set" would typically involve bench testing of the new screw head design and the predicate design for properties like torsional strength, insertion torque, and perhaps pull-out strength. The sample size for such bench tests would likely involve a statistically significant number of screws of each type, but this is not detailed in the summary.
   • Data Provenance: Not stated. Given the manufacturer is based in Finland, the testing would likely have been conducted in Europe or by contractors. It would be prospective bench testing designed specifically to compare the new and predicate designs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This is not applicable in the context of this 510(k). "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic devices or those requiring subjective clinical assessment. For a mechanical fixation device undergoing a minor design change evaluated by substantial equivalence, "ground truth" is typically established through objective engineering tests (bench testing) and comparison against established performance criteria of the predicate. Engineers and biomechanical specialists would design and execute these tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods (like 2+1 for discordant expert reads) are used in studies involving human interpretation or clinical outcomes where subjectivity might exist. For objective engineering bench tests, results are typically quantitative and directly compared, not "adjudicated."

4. 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 mechanical orthopedic fixation device, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance in image interpretation.

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

   • Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of device, especially for a special 510(k), is primarily objective engineering and biomechanical data (e.g., torsional strength, insertion torque, material properties) derived from bench testing comparing the modified device to the predicate device and ensuring it meets its original performance specifications and does not introduce new risks.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device, so there is no "training set" in that sense. If referring to product development testing, materials were iterated and developed, but not as a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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