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The Solana Surgical, LLC FuseForce Implant System is intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as: LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies

The Solana Surgical FuseForce Implant is a one-piece device made of Nickel Titanium Alloy intended to be implanted in the bones of the hand or foot. The implant is available in a range of sizes (12) ranging from 8 mm X 8 mm to 25 mm X 22 mm including both straight top and step top configurations. The design of the Solana Surgical implant is similar to the predicate device. No new materials or processes are used in the production of this implant. The device is provided in a sterile package which includes associated single use (disposable) instruments.

Acceptance Criteria and Study Details for Solana Surgical FuseForce Implant System

This document outlines the acceptance criteria for the Solana Surgical FuseForce Implant System and details the studies performed to demonstrate its compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FuseForce Implant System were based on its comparison to a legally marketed predicate device, the Memometal Memory Staples (K070031), and the Memometal EasyClip stable. The device was required to perform at least equivalently to the predicate in mechanical performance and corrosion resistance.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For both mechanical and corrosion testing, six subject devices and six predicate devices were evaluated for each test.
  • Mechanical Testing: 8mm x 8mm nitinol staples (worst-case for pullout, static, and fatigue bending).
  • Corrosion Testing: 25mm x 22mm nitinol staples (largest surface area, worst-case for corrosion susceptibility).
• Data Provenance: The data was generated through bench testing performed by Solana Surgical, LLC. The specific country of origin for the testing itself is not explicitly stated, but the company is based in Memphis, TN, USA. The data is prospective as it involves direct testing of the manufactured devices.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

• This device is a mechanical implant, and the ground truth for its performance is established through objective, standardized mechanical and material testing protocols (ASTM F564 and ASTM F2129).
• Therefore, the concept of "experts establishing ground truth" in the cognitive or interpretive sense, as seen in imaging studies, is not applicable here. The "ground truth" is defined by the objective measurements obtained from the testing.
• No human experts were used to establish ground truth in the context of interpretation or consensus for these purely mechanical and material property tests.

4. Adjudication Method

• Not applicable as the ground truth is established through objective, quantitative measurements from mechanical and material testing, not through expert interpretation requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for diagnostic imaging devices where human interpretation plays a role and the AI's impact on reader performance is being evaluated. The FuseForce Implant System is a mechanical implant, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. The FuseForce Implant System is a physical medical device, specifically a bone fixation staple. It does not employ an AI algorithm, and therefore, a "standalone algorithm performance" study is irrelevant.

7. Type of Ground Truth Used

• The ground truth used was objective performance data derived from standardized mechanical and material property testing against established ASTM (American Society for Testing and Materials) standards:
  • ASTM F564 (for mechanical properties: pullout, static bending, fatigue bending)
  • ASTM F2129 (for corrosion resistance)

8. Sample Size for the Training Set

• Not applicable. This device is a physical implant, not an AI algorithm that requires a training set. The performance is based on the material properties and design of the manufactured product.

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

• Not applicable, as there is no training set for this type of device.

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