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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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The Vilex External Fixation System is intended for external fixation with the following indications:

• Stabilization of Fractures & Osteotomy
• Rear and Mid-foot Arthrodesis
• Adult and Pediatric Leg Lengthening
• Correction of Bone Deformity in Upper & Lower Extremities

The Dynex® Ring Fixation System and Diametrix® Ring Fixation System fall within the Vilex External Fixation System product line. The systems consist of the following components:

• Dynex dynamic external fixation components (rings, footplates, and arches) or Diametrix static external fixation components (rings, footplates, and arches);
• Half pins and wires (regular and HA coated);
• Ball Markers for X-Ray;
• External fixation assembly hardware (e.g. wire fixation bolts, half pin bolts, struts, plates and posts, hinges, washers, support rods, and linear distractors); and
• Instruments (e.g. drills. drivers. tensioners. cutters, and benders).

The Dynex® Ring Fixation System components can be used as an external fixation and hexapod system, when configured with two or more rings and telescoping struts. The P&C CORA software (K151881) may be used in conjunction with the Dynex® Ring Fixation System to assist in pre-operative planning.

The Diametrix® Ring Fixation System components are traditional ring fixation components with frames that utilize tensioned wires and half pins.

Both systems utilize the same external fixation assembly hardware and instruments.

The Dynex rings, manufactured from aluminum, are offered in Full, 5/8, half and 3/8 sizes with footplates. The rings are circular with concentric inner and outer holes which provides versatility for hardware fixation points.

The Diametrix rings, manufactured from aluminum, are offered in in Full, 5/8, Half, and 3/8 sizes with footplates. The rings are tabbed which allows for multiple connection points and minimizes hardware interference.

The half pins and wires are constructed from stainless steel (ASTM F138 LVM). The coated half pins and wires are coated with Hydroxyapatite (HA). The half pins (Ø 3.0, 4.0, 4.5, 5.0, 6.0 mm) are provided in multiple lengths (60 – 200 mm) and are provided in sterile and non-sterile packaging. The wires are available in multiple designs (wire sharp bayonet, pear wire sharp bayonet, and wire bayonet olive) and are provided in 1.2. 1.5. and 1.8 mm diameters and range in length from 250 – 400 mm. The HA coated wires are provided sterile.

The external fixation rings, footplates, arches, struts, and assembly accessories are manufactured from stainless steel and anodized aluminum and are provided in various sizes to accommodate variations in patient size.

These components can be combined to create various frame assemblies.

The instruments and ball markers for X-Ray are manufactured from stainless steel.

This document (K202054) describes the Dynex Ring Fixation System and Diametrix Ring Fixation System. It is a 510(k) premarket notification, which means the manufacturer is claiming substantial equivalence to existing legally marketed predicate devices.

Crucially, this document states: "As the only differences between the subject and predicate devices are the product trade names, no additional performance data was submitted to demonstrate the substantial equivalence of the subject device to the predicate device."

Therefore, the provided document does not contain any information about acceptance criteria or a study that proves the device meets those criteria, as no new performance data was generated or submitted for this specific 510(k) clearance due to the nature of the submission (trade name changes only).

The information you are asking for (acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, etc.) is typically found in the documentation for the predicate devices that underwent more rigorous testing, or for novel devices that require de novo classification or PMA approval. This 510(k) is a "piggy-back" submission relying on the prior clearances of its predicates.

To answer your request, I must state that the provided text does not contain the necessary information. It explicitly says "no additional performance data was submitted."

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