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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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The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.

This 510(k) summary describes a device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths) that is a line extension of an existing product, and therefore does not include a study proving device performance against acceptance criteria in the same way a novel device might. Instead, it relies on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The study involved "fatigue testing" but the number of samples tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data for this 510(k) submission, as no clinical evidence was presented or required. The equivalence was shown through non-clinical (bench) testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a non-clinical (bench) study.

4. Adjudication method for the test set

• Not applicable. This was a non-clinical (bench) study.

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

• Not applicable. This is not an AI-powered device, and no clinical or MRMC studies were performed.

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

• Not applicable. This is not an algorithm or AI-powered device.

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

• For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and performance benchmarks established for the predicate device, or industry standards for intramedullary fixation rods. The summary indicates performance "at least as well as legally marketed predicate devices," implying the predicate's performance serves as the benchmark.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a "training set."

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

• Not applicable. See point 8.

Summary of the Study:

The study proving the device meets acceptance criteria was a non-clinical bench test, specifically fatigue testing. The purpose of this testing was to demonstrate substantial equivalence to the predicate VALOR® Ankle Fusion Nail System (K090857).

• Methodology: Fatigue testing was conducted on the subject device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths).
• Acceptance Standard: The acceptance criteria for the fatigue test were implicitly tied to the performance of the legally marketed predicate device. The new device needed to perform "at least as well as" the predicate.
• Results: The fatigue testing results indicated that the subject device "can be expected to perform at least as well as legally marketed predicate devices."
• Conclusion: Based on this non-clinical evidence, along with material and design comparisons, the device was deemed substantially equivalent, meaning it meets the necessary safety and effectiveness standards without requiring clinical studies. The only stated difference between the new device and the predicate was its overall length.

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