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The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)

Specific indications include:

• · Post-traumatic or degenerative arthritis
• · Previously infected arthrosis
• Revision ankle arthrodesis
• Failed total ankle arthroplasty
• · Avascular necrosis of the talus
• · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
• Rheumatoid arthritis
• · Osteoarthritis
• Pseudarthrosis
• · Trauma (malunited tibial pilon fracture)
• · Charcot foot
• · Severe endstage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis
• · Post-traumatic arthrosis
• · Neuroarthropathy

The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Vilex Redemption Duo Hindfoot Nail System." This type of document does not typically contain information about AI/ML device performance, acceptance criteria, or a study specifically designed to demonstrate meeting such criteria as it would for an AI/ML diagnostic or prognostic system.

Instead, this clearance letter is for a physical orthopedic implant system (intramedullary nail) that facilitates tibiotalocalcaneal arthrodesis (fusion). The "performance data" referred to in Section VII relates to mechanical testing of the implant's physical properties, not diagnostic accuracy or AI algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria, AI/ML device performance, sample sizes, ground truth establishment, or expert involvement, as these concepts are not applicable to the type of device described in this FDA clearance.

The document describes the device's technical characteristics and provides references to the following:

Device Name: Vilex Redemption Duo Hindfoot Nail System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB

Performance Data (Mechanical Testing):
The performance data provided supports the mechanical integrity and safety of the implant, not the performance of an AI algorithm. The tests performed are standard for orthopedic implants and include:

• Bending Fatigue per ASTM F1264-16e1
• Static Torsion per ASTM F543-17
• Driving Torque per ASTM F543-17
• Removal Torque per ASTM F543-17
• Axial Pullout Strength per ASTM F543-17
• Static Four-Point Bending per ASTM F1264-16e1
• Static Torsion per ASTM F1264-16e1
• Dynamic Four-Point Bending per ASTM F1264-16e1

The conclusion states that "Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device." This indicates that the mechanical tests demonstrated equivalent performance to predicate devices, satisfying the FDA's requirements for 510(k) clearance for this type of physical implant.

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The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws.

The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments.

All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.

This document describes the TITANEX™ MICROBEAM Screw System and TITANEX™ ARTEMIS Screw System, comparing them to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to mechanical testing per a standard (ASTM F543-17) and computational analysis, implying that the performance met the requirements set forth by these methods and their associated thresholds. The discussion section states, "the testing supports that these differences do not raise any new questions of safety and effectiveness," indicating successful performance without providing specific numerical results.

However, based on the provided text, we can infer the tested performance aspects:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any of the mechanical or computational tests, nor does it provide information on the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a medical device (screw system) that relies on mechanical and computational testing, not diagnostic performance tied to interpretations by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications such as radiologists is not applicable here. The "ground truth" would be established by the engineering standards and validation protocols used in the mechanical and computational analyses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., medical image reading). This document describes performance testing of a physical medical device (bone screws) and computational analyses. Therefore, an adjudication method in this context is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI-powered ones) that involve human interpretation of cases. The TITANEX™ systems are bone fixation screws, and their acceptance is based on mechanical and computational performance, not diagnostic accuracy or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to the TITANEX™ Screw System. The device is a physical implant, not an algorithm. The "standalone performance" here refers to its mechanical integrity and function as a standalone product. The performance data does describe standalone (algorithm-only) performance in the context of the computational analysis, which includes "Cross sectional Analysis" and "Axial Pullout per Chapman et al." These computational models would run independently without human-in-the-loop performance for their execution, although their validation and interpretation would involve human engineers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the physical properties and behavior of the screws measured against established engineering standards and specifications (ASTM F543-17). For computational analysis, the "ground truth" would be the mathematical models and scientific principles (e.g., Chapman et al. for axial pullout) that govern the expected behavior of the device under simulated conditions. It's not expert consensus, pathology, or outcomes data in the traditional medical sense, but rather adherence to validated engineering and scientific principles.

8. The sample size for the training set

The concept of a "training set" is applicable to machine learning or AI models. Since the TITANEX™ Screw System is a physical medical device (bone screws) and not an AI/ML product, there is no "training set."

9. How the ground truth for the training set was established

As there is no training set for this device, how its ground truth was established is not applicable.

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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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