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The VALOR® Hindfoot Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis in any of the following indications:

• Severe foot/ankle deformity.
• Osteoarthritis.
• Instability and skeletal defects after tumor resection,
• Neuro-arthropathic deformity or Charcot deformity,
• Avascular necrosis of the talus,
• Revision of a failed joint replacement or failed ankle fusion,
• Distal tibia fracture and non-unions,
• Rheumatoid arthritis and pseudoarthosis

The design features of the subject VALOR® Hindfoot Fusion Nail System are summarized below:

• Nails and screws are manufactured from titanium alloy.
• Nails are available in two diameters and a range of lengths.
• Screws are available in one diameter and a range of lengths.
  The subject nail in this Special 510(k) is a line extension of the system to include a 300mm length nail. The design features of the VALOR® Hindfoot Fusion Nail System are substantially equivalent to the design and features of other the devices in this product family previously cleared for market.

This document is a 510(k) premarket notification for the VALOR® Hindfoot Fusion Nail System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based medical device.

The document appears to be for a physical medical implant (an intramedullary fixation rod), not an AI/software device. Therefore, the questions regarding acceptance criteria, reported performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "Substantial Equivalence- Non-Clinical Evidence" section (Point 7 on page 5) states: "The subject 300mm nails do not provide a new worst case. From testing parameters performed on the predicate device, the 300mm nail will perform the same as the predicate in worst case testing because the working length and diameters have remained unchanged from the 250mm to 300mm nails." This refers to mechanical performance of the implant, not performance of an AI/algorithm.

Therefore, I cannot provide the requested information based on the provided text.

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Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, jount fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.

The ORTHOLOC® Calcaneal Plating System consists of 2 styles of plates (Tab and Perimeter) and features 3.5mm diameter locking and non-locking screws that range from 10-60mm each. The Tab plates are offered in three different sizes: small, medium, and large, and feature multiple tabs that can be manipulated or cut to accommodate for various patient anatomy. The Perimeter plates come in two sizes: small and large and also feature removable sections. The ORTHOLOC® hole design on the plates allow for the screws to be inserted from either side. This allows each plate to be used in either a right or a left orientation.

The provided document is a 510(k) summary for the ORTHOLOC® Calcaneal Plating System. This is a medical device submission to the FDA, not a study evaluating an AI device or a diagnostic tool that would typically have acceptance criteria in terms of performance metrics like sensitivity or specificity.

Instead, this document focuses on demonstrating substantial equivalence to a previously approved predicate device. The "acceptance criteria" here are related to fulfilling the requirements for substantial equivalence to warrant market clearance.

Here's an breakdown based on the information provided, framed as closely as possible to your request, but acknowledging the nature of this document:

1. Table of "Acceptance Criteria" (for 510(k) clearance) and Reported Device Performance (as presented for substantial equivalence):

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set (for mechanical testing): Not explicitly stated in the provided text. The document mentions "Mechanical testing, including Static Bend Testing and Screw through Plate testing," but does not specify the number of samples tested for each.
• Data Provenance: The mechanical testing was likely conducted in a lab setting by the manufacturer (Wright Medical Technology, Inc.), not from human or animal data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable (N/A). This is a mechanical device, and "ground truth" as typically defined for diagnostic or AI studies (e.g., by expert consensus on images) is not relevant here. The "ground truth" for mechanical testing is established by engineering principles and standardized test methods.

4. Adjudication Method:

• N/A. Adjudication is not applicable to mechanical testing in this context. The results of the mechanical tests (e.g., load to failure, displacement) are quantitative and directly measured.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is a hardware device (bone plating system), not a diagnostic or AI system. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance:

• No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used:

• Engineering Standards and Benchmarking: The "ground truth" for the performance of this device is based on established engineering test standards (e.g., ASTM or ISO standards for bone plates) and comparison to the mechanical properties of the legally marketed predicate device.

8. Sample Size for the Training Set:

• N/A. This is a physical medical device, not an AI or machine learning system that requires a "training set" in the computational sense. The design and manufacturing process would involve engineering specifications, and prototypes would be tested, but not in the context of an AI training set.

9. How the Ground Truth for the Training Set Was Established:

• N/A. As above, the concept of a training set and its associated ground truth isn't applicable to this type of device. The design specifications and performance targets are derived from medical requirements, biomechanical principles, and regulatory standards.

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