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The Futura Biomedical Subtalar Peg Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Examples include: Flat foot treatment in children and adolescents Congenital flat foot Unsuccessful long term orthopaedic treatment (shoes, insoles ... ) Tarsal coalitions Painful flat foot Supple deformity in posterior tibial tendon dysfunction Paralytic flat foot Subtalar instability This device is intended to be fixed with bone cement.

The Futura Biomedical Implant is a one-piece device made of UHMWPE or Cobalt Chromium with titanium plasma spray on the stem, intended to be implanted into the calcaneus of the foot. The implant is designed in 13 sizes and two configurations. The implant which is used in the treatment of excessive motion of the talus relative to the calcaneus acts as a spacer for the joint, maintaining the joint space, allowing for range of motion, but limiting excessive pronation.

This document is a 510(k) Summary for the Futura Biomedical Subtalar Peg Implant, comparing it to a predicate device, the Wright Medical STA-Peg implant. The purpose of this document is to demonstrate "substantial equivalence" to a legally marketed device, not to present a study proving the device meets specific acceptance criteria in the way an AI/ML device submission would.

Therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, expert involvement, and sample sizes for training/test sets is not applicable in this context. This document pertains to a traditional medical device (an implant), not a software as a medical device (SaMD) or an AI/ML-driven device.

However, I can extract the comparison between the new device and the predicate device, which serves a similar purpose of demonstrating safety and effectiveness based on existing, accepted technology.

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like an implant, acceptance criteria are typically met through demonstrating equivalence in design, materials, and intended use as compared to a legally marketed predicate device. The "performance" in this context refers to its ability to function as intended based on these equivalences.

Summary of How the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The study (the 510(k) submission itself) demonstrates that the Futura Biomedical Subtalar Peg Implant is substantially equivalent to the legally marketed predicate device (Wright Medical STA-Peg implant) based on the following:

• Similarities in Design Characteristics and Intended Use: Both devices are for single use, intended for surgical implantation, designed to prevent excessive pronation while allowing normal subtalar joint motion, and are made of comparably sized, industry-standard materials.
• Identical Indications for Use: The stated indications for both devices are precisely the same, covering various conditions associated with hyperpronated foot and subtalar joint instability.
• Similar Device Mechanics: Both implants function as spacers to maintain joint space and limit excessive pronation.
• Material Equivalence: While the new device offers an additional material option (CoCr/CpTi), UHMWPE is common to both, and the provided materials are understood to be suitable for this application.
• Fixation Method: Both devices are intended for stem-in-bone fixation, with the Futura device explicitly mentioning fixation with bone cement, which is a common and accepted method.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a submission for a traditional implant, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance. The "test" is the comparison to the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert consensus for AI/ML devices, is not a concept applied to the substantial equivalence determination of a traditional implant. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Not applicable. This concept does not apply to this type of device submission.

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-driven device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-driven device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the safety and effectiveness profile of the legally marketed predicate device (Wright Medical STA-Peg implant), which has already established its performance in clinical use and met regulatory requirements. The new device is deemed acceptable because it is substantially equivalent to this established device.

8. The Sample Size for the Training Set:
Not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no "training set" for this type of device.

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