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The NuGait™ Subtalar Implant System restricts excessive subtalar pronation in the downward, forward, and medial planes, providing for a more normal subtalar joint motion in patients. The NuGait Subtalar Implant System is intended for the following pathological conditions resulting from disease, injury, or other trauma: • Hypermobile pes valgus; • Posterior tibial • tendon dysfunction; • Severe pronation; • Subtalar instability; • Hypermobile flexible congenital flat foot.

The NuGait Subtalar Implant System consists of a one-piece arthroereisis implant designed to stabilize the subtalar joint of the hyperpronated foot and associated instrumentation. The NuGait implant is constructed of Ti-6Al-4V ELI titanium alloy and is offered in 5 sizes to fit a range of anatomies. The subject device is also cannulated to allow precise insertion when used with a guide wire and system instrumentation. The outer surface of the implant features a helical thread to aid fixation within the sinus tarsi. Each NuGait is packaged individually and sterilized via gamma radiation. These devices are intended for single use only.

This document is a 510(k) premarket notification for a medical device (NuGait™ Subtalar Implant System) and, as such, outlines the basis for substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the typical sense of a clinical trial for a new drug or novel medical device.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given document. This document focuses on demonstrating that the new device is as safe and effective as an already legally marketed device through technological characteristics and non-clinical data.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of quantitative acceptance criteria for device performance in the way one might expect for a diagnostic or efficacy study. Instead, the basis for approval is "substantial equivalence" to a predicate device.

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

• Sample Size for Test Set: Not applicable. No clinical test set data was used or required for this 510(k). The evaluation relied on non-clinical (engineering/bench) testing and comparison to a predicate device.
• Data Provenance: Not applicable for a clinical test set. The non-clinical data would have been generated internally by Ascension Orthopedics, Inc.

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

• Not applicable. There was no clinical test set requiring expert-established ground truth.

4. Adjudication method for the test set

• Not applicable. No clinical test set was used.

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 device is a subtalar implant, not an AI-assisted diagnostic tool or system designed for human readers.

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

• Not applicable. This device is a physical implant, not an algorithm or software.

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

• Not applicable for clinical ground truth. The "ground truth" for this submission is based on the established safety and effectiveness of the legally marketed predicate device (Sub-Talar Lok™ Arthroereisis Implant System) and the demonstration that the NuGait™ device has comparable intended use, technological characteristics, and material properties, supported by non-clinical bench testing (e.g., bending strength).

8. The sample size for the training set

• Not applicable. This device is a physical implant, not a machine learning model requiring a training set.

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

• Not applicable. This device is a physical implant, not a machine learning model.

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