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Lucent intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Lucent Magnum+ is an intervertebral body fusion device intended for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s).

This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.

Crystal devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

Vertu devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Spinal Elements' Ti-Bond® is an additive plasma sprayed coating of commercially pure titanium conforming to ASTM F1580. Spinal Elements' devices are coated with Ti-Bond®f on their surfaces. Spinal Elements Ti-Bond® coating presents a macro-, a micro and a nano-surface structure.

This document is a 510(k) Premarket Notification for Spinal Elements Ti-Bond coated devices, stating that the coating does not change the previously cleared devices or their indications for use. Therefore, it does not contain the information requested about acceptance criteria and a study proving a device meets those criteria because the device being reviewed is a coating applied to existing devices, and the submission argues for substantial equivalence based on the coating not changing the previously cleared devices.

Here's why the requested information cannot be extracted directly from this document:

1. Nature of the submission: This is a 510(k) for a coating (Ti-Bond) for already cleared intervertebral body fusion devices. The core argument is that applying this coating does not alter the fundamental safety or effectiveness of the devices, and thus they remain substantially equivalent to their predicates. It's not a submission for a new device with new performance claims requiring extensive new clinical or performance studies to establish standalone acceptance criteria.
2. No New Performance Claims: The document explicitly states: "The indications for use of the devices coated with Ti-Bond® are not being modified from the ones cleared in their respective 510(k)..." and "There are no changes to the predicate devices coating. All technical characteristics remain identical." This means that the device is relying on the previous clearances of the predicate devices for performance, rather than providing new performance data for this specific 510(k) submission that would require detailed acceptance criteria and a study proving they are met.
3. Performance Data Section: The "Performance Data" section merely states: "In support of this 510(k) Premarket Notification, Spinal Elements has conducted nonclinical testing demonstrating that the Spinal Elements Ti-Bond® coating present a surface topography at a macro, a micro and a nano scale." This describes a characterization of the coating's physical properties, not a study against specific acceptance criteria related to a device's clinical performance (e.g., fusion rates, pain reduction, etc.).

Therefore, the document does not provide the specific details regarding acceptance criteria and a study to prove they are met as you've requested. The information you're looking for (acceptance criteria for clinical performance, sample sizes for test/training sets, expert qualifications, etc.) would typically be found in the original 510(k) submissions for the predicate devices themselves, or in a 510(k) for a novel device where new performance claims are being made.

If this were a submission for a new device, the "Performance Data" section would be much more extensive and detail specific studies (e.g., biomechanical testing, clinical trials, animal studies) conducted to demonstrate safety and effectiveness against predefined acceptance criteria for that device.

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