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Cannulated SmartScrew™ is intended for maintenance of alignment of cancellous fractures of the malleolus of the ankle in the presence of appropriate immobilization. In conjunction with adequate surgical technique and postoperative immobilization, the Cannulated SmartScrew™ provides secure fixation and will maintain sufficient physical integrity and mechanical holding properties within the bone, well beyond the five to eight weeks needed for complete biological healing and realignment of the fixation site.

The Cannulated SmartScrew™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (diaphyseal area), 2) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism).

The Cannulated SmartScrew™ is composed of 100% poly-L-lactide ("PLLA") polymer. It is supplied with diameter 4.5mm and lengths 40, 45, 50, 55, 60, 65, 70mm. It is cannulated for 1.5mm K-wire.

The provided text is a 510(k) summary for the Bionx Implants Inc. Cannulated SmartScrew™. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study with detailed statistical results. The document states: "Furthermore, the minor technological differences between the Cannulated SmartScrew™ and the predicate devices do not raise any new issues of safety or effectiveness." This implies that due to its similarity to already approved devices, extensive new performance studies were not deemed necessary for this submission.

Therefore, I cannot provide the requested information from the given text.

Summary of missing information:

• Acceptance Criteria Table: Not present.
• Reported Device Performance: Not present.
• Sample size for test set and data provenance: Not applicable as a dedicated test study with a test set isn't described.
• Number of experts used to establish ground truth & qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted/described.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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