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The IdentiTi Porous Ti Interbody System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi Porous Ti Interbody System is intended for use with supplemental fixation systems and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.

The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.

Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.

Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. IdentiTi LLIF interbody spacers with >20° lordosis must be used with LLIF AMP integrated fixation to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

The IdentiTi Porous Ti Interbody System is an intervertebral body fusion system implanted from an anterior, anterolateral, lateral or posterior approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.

The IdentiTi Porous Ti Interbody System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.

The provided document, K183705, is an FDA 510(k) premarket notification for a medical device (IdentiTi™ Porous Ti Interbody System). It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on its own performance metrics (e.g., accuracy, sensitivity, specificity for an AI/algorithm-based device).

The document explicitly states under "VII. PERFORMANCE DATA":
"Nonclinical testing performed on the predicate devices supports the design of the subject IdentiTi Porous Ti Interbody System. Additionally, the following testing was performed on the subject interbody implants:

• Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
  The results demonstrate that the subject IdentiTi Porous Ti Interbody System is substantially equivalent to other predicate devices for nonclinical testing.

Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

This means the submission did not include a study proving the device meets acceptance criteria related to clinical performance, general diagnostic accuracy, or human improvement with AI assistance. It relied on demonstrating equivalence in design, technology, and nonclinical performance to already cleared predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for clinical performance, as such a study was not presented in this 510(k) submission.

The document's purpose is to confirm the new device is as safe and effective as a legally marketed device, not to present novel performance data.

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