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The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the biomechanical reduction of abnormal intermetatarsal angle.
The Instratek HAV-Lok Bunion Correction System is intended for the following surgical indications: To assist in the correction of Hallux Valgus deformities by providing reduction of the 1st intermetatarsal angle.

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This device, the Instratek HAV-Lok Bunion Correction System, is a traditional 510(k) submission and does not include any studies related to AI/algorithm performance or acceptance criteria in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such information is present in the provided document.

The document states:

• "The technological characteristics between the predicate and proposed devices are the same."
• "There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness."
• "The HAV-Lok Bunion Correction System, as designed, is as safe and effective as the predicate devices. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market."

This indicates that the device's acceptance was based on its similarity to an already approved device, not on new performance studies with specific acceptance criteria that would typically be associated with AI or novel diagnostic technologies.

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