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The Tiger Shark Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TiGER SHARK Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/ or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

The ChoiceSpine Tiger Shark™ Cervical Spacer System consists of intervertebral body fusion devices comprised of titanium alloy (Ti-6AI-4V ELI per ASTM F3001, Class C). The spacers have a basic oval shape that coincides with the shape of vertebral bodies and a hollow center for placement of bone graft. They are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method.

The provided text describes a 510(k) premarket notification for a medical device cleared by the FDA, the ChoiceSpine Tiger Shark™ Cervical Spacer System. This type of submission focuses on proving substantial equivalence to a predicate device, rather than extensive de novo clinical studies with acceptance criteria for AI performance. Therefore, the requested information about acceptance criteria, study design for AI models, expert adjudication, MRMC studies, and ground truth establishment for AI performance is not applicable to this document.

The document primarily details:

• Device Name: ChoiceSpine Tiger Shark™ Cervical Spacer System
• Regulation Number/Name: 21 CFR 888.3080, Intervertebral Body Fusion Device (Class II)
• Product Code: ODP
• Indications for Use: Anterior cervical spine intervertebral body fusion for degenerative disc disease (DDD) at one level (C2-C3 to C7-T1), in skeletally mature patients after 6 weeks of non-operative treatment, used with supplemental fixation and autogenous/allogenic bone graft.
• Device Description: Intervertebral body fusion devices made of titanium alloy, available in various heights and lordosis angles, manufactured using Electron Beam Melting (EBM) additive manufacturing.
• Predicate Devices: Genesys Spine Apache Cervical Interbody Fusion System (K150812) and ChoiceSpine Tiger Shark Cervical Spacer System (K183397).
• Purpose of Submission: To gain clearance for an additional titanium implant footprint (18x15mm) and instruments.
• Substantial Equivalence Conclusion: The device is similar to predicate devices in principle of operation, indications for use, stabilization method, anatomic location, approach, product code, classification, and biocompatibility. Minor differences (e.g., allogenic bone graft use, sterile provision) do not alter intended use or create a new worst case. Sterilization validation was performed.

To directly answer the prompt's request for acceptance criteria and study proving device meets them, based solely on the provided text, the information is not present as this is a traditional medical device clearance, not an AI/ML software clearance.

Therefore, the table and detailed points regarding AI/ML performance acceptance criteria cannot be fulfilled from this document.

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