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The Medline UNITE® Snap-Off Screws are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

The Medline UNITE® Snap-Off Screws are manufactured from titanium alloy. The screws include a groove between the head and the drive mechanism that is intended to snap off the drive mechanism below the surface of the head of the screw. The screws are offered in various diameters, lengths, and thread lengths.

The provided documents describe a 510(k) premarket notification for the Medline UNITE® Snap-Off Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of studies you've outlined.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts used or their qualifications for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the submission utilizes non-clinical testing to demonstrate that the new device does not present a new worst-case scenario compared to the predicate device in terms of torsional or pullout strength. It explicitly states, "Summary of Clinical Testing: Not applicable."

The core of this 510(k) submission is to demonstrate:

• Same Intended Use: Both the predicate and subject device are indicated for use in bone reconstruction, osteotomies, joint fusion, fracture repair, and fracture fixation.
• Same Indications for Use.
• Same Materials: Both are manufactured from titanium alloy (Ti-6AL-4V).
• Similar Design Features: Although the subject device introduces a snap-off mechanism and a three-pronged external drive, the overall function as a bone fixation fastener is similar to the predicate cannulated screws.
• Non-clinical Testing: The critical aspect highlighted is that "The subject screw does not present a new worst-case when compared to the predicate screw in torsional or pullout strength." This is the primary "proof" of equivalence for mechanical properties.

In summary, this document supports the substantial equivalence of a medical device by comparing its characteristics and performance to an already legally marketed predicate device, primarily through engineering and material compatibility, and demonstrating no new worst-case performance in relevant mechanical tests, rather than establishing and meeting specific performance acceptance criteria through clinical or AI-specific validation studies as described in your request.

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