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BePOD® 3A cannulated screws are designed for the following indications:

• Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.

• Compressive osteosynthsis of fractures of several bones in the forefoot.

BePOD® percutaneous cannulated screws are designed for the following indications:

• Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.

• Compressive osteosynthesis of fractures of several bones in the forefoot.

BePOD® Foot Screws includes the following elements: BePOD® 3A cannulated screws BePOD® percutaneous cannulated screws

The BePOD® Foot Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

This document is a 510(k) premarket notification for a medical device called "BePOD® Foot Screws." It aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as existing devices.

The information provided does not describe a study involving an AI/Machine Learning device or a diagnostic device, but rather a Class II surgical implant (bone screws). Therefore, the questions related to AI/ML device performance (like "acceptance criteria and reported device performance" for an AI/ML model, "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set") are not applicable to this document.

The document focuses on demonstrating substantial equivalence based on materials, sizes, design features, and intended use compared to predicate devices. It states:

• Device Description: BePOD® Foot Screws include BePOD® 3A cannulated screws and BePOD® percutaneous cannulated screws, intended for implantation using dedicated instrumentation.
• Indications for Use:
  • Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy.
  • Compressive osteosynthesis of fractures of several bones in the forefoot.
• Comparison of Technological Characteristics: The BePOD® Foot Screws and selected predicate devices (Auto® Fix Screws by SBI, BePOD® Cannulated Arthrodesis screws by FH Industrie, CALCANAIL Fracture by FH Industrie) share similarities in:
  • Materials used.
  • Available ranges of sizes.
  • Design features.
• Performance: The document states that the BePOD® Foot Screws are "identical in materials and size of the predicates selected." It also notes that "Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations."
• Substantial Equivalence: Claimed based on manufacturers' commercial documents and 510(k) submission information available on FDA's website for the predicate devices.
• Conclusion: The manufacturer believes the BePOD® Foot Screws are substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, and safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (bone screws) and does not contain the kind of performance study data that would be relevant to the questions posed, which are typically for diagnostic AI/ML medical devices.

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