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The APTUS® 1.5 TriLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

• Management of the fractures of the distal, middle and proximal phalanges and metacarpals
• Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodoses .

APTUS® Radius 2.5 group:

• . Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• . Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

The APTUS 1.5 TriLock consists of titanium TriLock plates and titanium TriLock screws with locking function. The system is intended to be used for internal fixation of small bones. The 1.5 TriLock plates may also be used with existing standard 1.2 mm (thread diameter) and 1.5 mm (thread diameter) cortical bone screws cleared under APTUS® Titanium Fixation System. K051567. The only modifications being made in this submission are the addition of eight (8) plates, all 0.8 mm in thickness, having various screw hole and design configurations, and the addition of ten (10) screws, all having a major thread diameter of 1.5 mm, all with a locking head design, provided in lengths ranging from 4 mm to 13 mm in 1 mm increments. The technological differences between the subject device and the predicate include a change in the thickness of the plates and the change in plate configurations and the change in screw head design to allow locking to the plates.

The provided document is a 510(k) Summary for a medical device (APTUS® 1.5 TriLock) and does not describe an AI/ML study. It details the device's intended use, description, and claims of substantial equivalence to a predicate device based on performance data that includes dimensional analysis, insertion, shear, and pullout testing of screws, and fatigue testing of plates.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML study, as the document pertains to a traditional medical device submission.

Here's why and what information is available:

• No AI/ML Component: The document does not mention any artificial intelligence, machine learning, software algorithm, or diagnostic aid. It describes a physical orthopedic fixation system (plates and screws).
• Performance Data Type: The "performance data" referred to is related to the mechanical properties of the implants (e.g., screw insertion/pullout strength, plate fatigue life), not diagnostic accuracy or AI model performance.
• Substantial Equivalence: The submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (APTUS® Titanium Fixation System, K051567), a common pathway for medical device clearance. This involves showing similar intended use, technological characteristics, materials, and mechanical performance.

Therefore, all requested points related to AI/ML study components (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone algorithm, training set, etc.) are NOT applicable to this document.

The "acceptance criteria" for this device would be the demonstration of substantial equivalence through meeting comparable mechanical performance benchmarks to the predicate device, which are implicitly accepted by the FDA clearance. The "study" proving this involves the specific mechanical tests mentioned:

• Detailed dimensional analysis of subject and predicate screw designs.
• Insertion, shear, and pullout testing of subject and predicate screws.
• Fatigue testing of subject and predicate plate designs.

Without the actual reports for these mechanical tests, specific numerical acceptance criteria and performance results cannot be extracted. The summary only states that these tests were "provided to demonstrate substantial equivalence."

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