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The Blackhawk™ Ti Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

The Blackhawk™ Ti Cervical Spacer System is an anterior cervical interbody device consisting of a titanium alloy (Ti-4Al-6V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al- 4V ELI) anchors per ASTM F136, and a titanium alloy (Ti- 6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal anchors that lock on deployment and provide additional fixation.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML algorithm or software.

The document is a 510(k) premarket notification approval letter for the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, which is a medical device for anterior cervical interbody fusion procedures. The content focuses on:

• Regulatory clearance: FDA clearance based on substantial equivalence to predicate devices.
• Device description: Materials (titanium alloy, nitinol), components (implant cage, internal locking components, anchors, locking cam), and sizes.
• Intended use/indications: Anterior cervical interbody fusion for degenerative disc disease at one disc level (C2-T1) with autogenous/allogenic bone graft and supplemental fixation.
• Predicate devices: Comparison to previously cleared ChoiceSpine and Exactech cervical spacer systems.
• Non-clinical testing: Mechanical tests (static subsidence, expulsion, dynamic axial compression, dynamic compression-shear, dynamic torsion) to demonstrate equivalence to predicates. These are engineering performance tests of the physical implant, not studies involving human readers or AI performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are related to studies evaluating AI/ML-driven medical devices, which is not the subject of this document.

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