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The Suturtek 360° Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.

The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy.

The device is sterilized before each use. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the tissue. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are placed in the same manner and then the ends of the suture are tied together in the usual fashion.

The provided document is a 510(k) Summary of Safety and Effectiveness for the SuturTek 360° Sternal Closure Device™. This submission process seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a standalone study with ground truth establishment and expert adjudication.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of device performance evaluation.

Instead, the submission relied on demonstrating equivalence to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ (K032468).

The document states:

• "Documentation was provided which demonstrated that the SuturTek 360° Sternal Closure Device™ is substantially equivalent to the predicate device, the SuturTek FASTCLOSE™ Sternum Closure Device™ K032468"

This type of submission focuses on comparing the new device's design, materials, and intended use to a device already cleared by the FDA, rather than conducting a de novo study to establish performance metrics against a defined standard.

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