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The Choice Spine Lumbar Spacer System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1 in skeletally mature patients who have had six mon-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The designed for use with supplemental fixation and with autogenous and/or

allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion When used as a vertebral body replacement device, the Choice Spine Intervertebral Body Device is intended for use in the thoracic and lumbar spine, from T1 to L5, for the replacement of a collapsed or unstable vertebral body resulting from a tumor or traumatic injury. The device system is designed for use with supplemental fixation and with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion. Choice Spine Interbody Fusion System (Harrier™):

The Choice Spine Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Choice Spine Interbody Fusion System is designed to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Choice Spine Vertebral Body Replacement System (Hawkeye™):

The Choice Spine Vertebral Body Replacement (VBR) System is in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Choice Spine Vertebral Replacement (VBR) System is intended for use with supplemental fixation and is to be used with autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft to facilitate fusion

The implant components are available in two material varieties, Materials: polyetheretherketone (PEEK-OPTIMA® LT1, Invibio® or Zeniva® PEEK, Solvay) as described by ASTM F2026 with integral radiopaque markers manufactured from tantalum as described by ASTM F560. The second implant variety is Titanium alloy (Ti-6Al-4V ELI) which conforms to ASTM F136. All chosen materials are commonly used in medical devices. The implants will be provided non-sterile, but will be steam sterilized before use.

This document is a 510(k) premarket notification from the FDA for several spinal interbody fusion devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on regulatory clearance, device descriptions, and comparison to predicate devices, but lacks the specific details requested in your prompt regarding performance studies.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states that because the designs of the implants are similar between material types (PEEK or Titanium Alloy) and have been previously cleared, and the Titanium implants are expected to be stronger, "no new non-clinical testing is needed." This explicitly indicates that no new performance studies (which would involve acceptance criteria and test sets) were conducted for this specific submission.

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