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The EVOL® ha - C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with degenerative disc disease (DDD) at up to two contiguous levels from C2 - T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of nonoperative treatment.

The EVOL® ha - C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and depth), height, and lordotic angle. All sizes have a central window for autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.

The provided text is a 510(k) Summary for the EVOL® ha - C Cervical Interbody Fusion System. It describes a medical device, its intended use, and its equivalence to predicate devices, primarily through non-clinical performance testing and a clinical literature review.

Crucially, there is no mention of a study involving AI, machine learning, or software performance in this document. The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are relevant to studies validating AI/ML-based medical devices.

Since this 510(k) is for a physical intervertebral body fusion device and does not involve AI or software, it does not contain the information required to answer the specific questions about AI/ML device acceptance criteria and study proof.

The document states:

• "Testing was performed for the EVOL® ha – C Cervical Interbody Fusion System and demonstrated substantial equivalent performance to the identified predicates. The mechanical tests were performed in accordance to these test methods: ASTM F2077, ASTM F2267, Expulsion Testing. The tests performed include: static & dynamic tests for compression, torsion, and compression shear. Subsidence and expulsion tests were also performed." This refers to bench testing of the physical implant related to its biomechanical properties.
• "Comprehensive, clinical literature review of published data for cervical interbody fusion devices, similar to the EVOL® ha - C Cervical Interbody Fusion System, was performed to support the Indications for Use at two levels." This refers to a review of existing scientific literature on similar devices, not a new clinical study conducted for this specific device.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study proof from this document.

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