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Intended for fixation during the healing process for:

• . Syndesmotic trauma, such as syndesmosis disruptions in connection with Weber B and C ankle fractures.
• . Reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-201 metatarsal (IM) angle.

The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for fracture fixation between two bone segments and/or realignment and stabilization of an underlying skeletal (bony or soft tissue) deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the KISSloc™ Suture System. This document does not contain information related to an AI/ML medical device submission. It pertains to a mechanical fixation device (suture system) and its substantial equivalence to previously marketed predicate devices based on non-clinical mechanical testing.

Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML device, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop studies. These concepts are relevant to the evaluation of AI/ML software as a medical device (SaMD), but not to the traditional mechanical device described in this 510(k).

The document explicitly states: "No clinical data was provided in support of this substantial equivalency." and the evaluation was based on "non-clinical testing" like "Static tensile load to failure".

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