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The REDEMPTION Beaming System is indicated for fracture fixation, osteotomies, reconstruction procedures, and fusions of bones in the foot and ankle including the Metatarsals, Cuboid, Navicular, Calcaneus and Talus. Specific examples include: Medial Column Fusion and Lateral Column Fusion resulting from neuropathic osteoarthropathy (Charcot).

The REDEMPTION Ø3.5mm Headless Screws are indicated for small bone fragments fracture and osteotomy in the lower extremities primarily the foot.

The REDEMPTION™ Beaming System, consisting of the REDEMPTION™ Beams and the REDEMPTION™ Nails, is a reconstruction solution providing various diameters of cannulated screws.

The REDEMPTION™ Beams are provided in diameters of Ø5.0 mm, Ø6.5 mm, and Ø8.0 mm, and are cannulated and either partially or fully threaded. The Ø5.0 mm beams are available in 35 mm to 130 mm lengths (5 mm increments) and the Ø6.5 mm and Ø8.0 mm beams are available in 40 mm to 160 mm lengths (5 mm increments).

The REDEMPTION™ Nails are provided in diameters of Ø7.5 mm and Ø8.2 mm and are partially threaded. The nails range in length from 50 mm (5 mm increments).

The REDEMPTION™ Headless 3.5 mm screw can be used as a cross screw with the nail and are offered in lengths from 12 mm to 60 mm.

All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, drill guides, implant inserters, implant drivers, and a targeting guide are required for use with the system. The REDEMPTION™ instruments are manufactured from stainless steel and radel (plastic).

The provided text is a 510(k) summary for the REDEMPTION™ Beaming System, a medical device for bone fixation. It details the device's description, indications for use, comparison to predicate devices, and performance data submitted in support of substantial equivalence.

However, the provided document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML device performance. The content is focused on the mechanical and material properties of a traditional medical device (bone fixation fastener), not an AI/ML powered device.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (for AI/ML)
• Sample size and data provenance for a test set (for AI/ML)
• Number and qualifications of experts for ground truth (for AI/ML)
• Adjudication method (for AI/ML)
• MRMC comparative effectiveness study or effect size (for AI/ML)
• Stand-alone (algorithm only) performance (for AI/ML)
• Type of ground truth used (for AI/ML)
• Sample size for training set (for AI/ML)
• How ground truth for training set was established (for AI/ML)

The "Performance Data" section in the document lists:

• Static Four Point Bend Testing per ASTM F1264-16
• Mechanical testing per ASTM F543-17 (Insertion Torque, Removal Torque, Pull-out Force, Ultimate Torque)
• Computational Analysis
• Cleaning and sterilization validations

These are all standard engineering and biocompatibility tests for traditional medical implants, not for the evaluation of AI/ML algorithms.

In summary, the provided document does not describe an AI/ML-driven device or study its performance against the criteria typically associated with AI/ML medical devices.

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