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The Alta® Fully Threaded Cross-Locking 5.0mm Screw is indicated for use in fractures requiring static and dynamic locking applications which include the Intramedullary Rods in the Alta® Femoral and Alta® Tibial /Humeral Rod Systems. Specifically, these screws will be used with the Alta® Femoral Locking IM Rod (K850441 & K822266), the Alta® CFX Reconstruction Rod (K926232, K935295, & K960524), the Alta® Tiblal/Humeral IM Rod (K884500, K890936, and K954554), and the Alta® Retrograde Rod (K972108).

The Alta® Fully Threaded Cross-Locking 5.0mm Screw is a cross-locking screw with continuous threading along the entire shaft. The design modification involves changing the hex head design to a T25 standard drive feature. The modified device will be a new screw for use with the Alta System. The modified component, the Alta® Fully Threaded Cross-Locking 5.0mm Screw, is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process. Alta® Fully Threaded 5.0mm Screws are manufactured from Titanium (Ti6Al-4V ELI) Alloy, which conforms to ASTM F-136.

The provided document is a 510(k) Premarket Notification for a medical device, the "Alta® Fully Threaded Cross-Locking 5.0mm Screw". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or human-in-the-loop study details.

Here's why and what information is available:

• Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves comparing design features, materials, intended use, and performance claims (if any new claims are made) to the predicate. It does not usually involve new clinical studies or the establishment of new performance acceptance criteria for the device itself.
• Device Modification: This specific submission is a "Special 510(k)" for a design modification. The modification is changing the hex head design of an existing screw to a T25 standard drive feature. This further emphasizes that it's an update to a known device, not a brand-new one requiring extensive performance evaluations against new criteria.
• Focus on Claims: The document states, "The Alta® Fully Threaded Cross-Locking 5.0mm Screw is substantially equivalent to the predicate device which was cleared for marketing via the 510(k) process." This highlights that the review concerns equivalence, not new performance data.

Therefore, I cannot populate the table or answer the questions as the requested information is not present in this 510(k) summary.

However, I can provide the available relevant information from the document:

• Device Name: Alta® Fully Threaded Cross-Locking 5.0mm Screw
• Predicate Device: Osteo System Locking Screw (modified version)
• Design Modification: Changing the hex head design to a T25 standard drive feature.
• Material: Titanium (Ti6Al-4V ELI) Alloy, conforming to ASTM F-136.
• Intended Use: Identical to the Osteo System Locking Screw, for use in fractures requiring static and dynamic locking applications with specific Alta® Intramedullary Rod Systems.
• Regulatory Class: Class II
• Product Code: OR (87) HSB

To answer the detailed questions about acceptance criteria and performance studies, one would typically need access to the full 510(k) submission, including potentially bench testing data or prior predicate device testing documentation, which is not included in this summary.

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