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The IdentiTi Porous Ti Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi Porous Ti System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with IdentiTi LIF interbody spacers to provide integrated fixation. IdentiTi LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

IdentiTi NanoTec Interbodv System

The IdentiTi Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the IdentiTi NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The IdentiTi NanoTec Interbody System is intended for use on patients who have had at allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with IdentiTi NanoTec LIF interbody spacers to provide integrated fixation. IdentiTi NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.

IdentiTi Cervical Porous Ti Interbody System

The IdentiTi Cervical Porous Ti Interbody System is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The ldentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi NanoTec Cervical Interbody System

The IdentiTi Cervical Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

IdentiTi Cervical Standalone Interbody System

The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi NanoTec Cervical Standalone Interbody System

The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use in skeletally mature patients for the treatment of cervical degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with autograft, allograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

ldentiTi ALIF Standalone Interbody System

The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved levels.

Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/ or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The ldentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The ldentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine.

ldentiTi NanoTec ALIF Standalone Interbody System

The IdentiTi ALIF Standalone Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and

radiographic studies. These patients may have up to Grade 1 spondylolisthesis at the involved levels.

Additionally, the IdentiTi NanoTec ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi Nanotec ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi NanoTec ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi NanoTec ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi NanoTec ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

Transcend PEEK Interbody System

The Transcend PEEK Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Transcend PEEK Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Transcend PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation , the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with Transcend LIF interbody spacers to provide integrated fixation. Transcend LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. Transcend ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.

Transcend NanoTec Interbody System

The Transcend PEEK Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Additionally, the Transcend NanoTec Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Transcend NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation , the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

AMP™ Anti-Migration Plate may be used with Transcend NanoTec LIF interbody spacers to provide integrated fixation. Transcend NanoTec LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation.

Transcend Cervical PEEK Interbody System

The Transcend PEEK Cervical Interbody System is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2- T1. The Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

Transcend NanoTec Cervical Interbody System

The Transcend Cervical PEEK Interbody System with advanced NanoTec surface treatment is an anterior cervical interbody fusion system intended for use in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec Cervical Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft, allograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion.

The IdentiTi and Transcend Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through an anterior surgical approach, and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and posterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI), and commercially pure titanium (CPTi Grade 2) per ASTM F67. The interbody spacers are available in the following material options: (1) PEEK (polyetheretherketone) with tantalum and titanium alloy markers, or (2) commercially pure porous titanium (PTi), or (3) a combination of commercially pure porous titanium (CPTi Grade 2) per ASTM F67 and titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The subject IdentiTi and Transcend Interbody Systems implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. To mitigate risk of expulsion, the interbody endplates feature teeth. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. Additionally, the IdentiTi implants are offered with a microstructure due to the layering of material that forms the porous architecture. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation.

The IdentiTi and Transcend NanoTec Interbody Systems implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The purpose of this Traditional 510(k) is to receive clearance for expanded indications for use of the IdentiTi and Transcend Interbody Systems with bone void filler cleared by FDA for use in intervertebral body fusion to facilitate fusion, and to add a nanotechnology claim in alignment with FDA's Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.

The provided text describes the 510(k) premarket notification for the IdentiTi and Transcend Interbody Systems, which are intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device safety and effectiveness through clinical studies with acceptance criteria in the typical sense of a novel device.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and details on training/test sets are not applicable in this context, as the submission relies on non-clinical performance data and comparison to already cleared predicate devices.

However, I can extract information related to the device's performance in non-clinical testing and the rationale for the nanotechnology claim.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence based on non-clinical testing and nanotechnology claims, explicit "acceptance criteria" in the sense of clinical performance endpoints are not provided. Instead, the document mentions "in vitro evaluations" for the nanotechnology claim and adherence to ASTM standards for mechanical testing. The reported performance is that these tests were "performed and included" or "referenced in predicate 510(k) submissions to support clearance." For the nanotechnology claim, the "reported device performance" is the demonstrated statistically significantly increased proliferation, alkaline phosphatase activity, and mineralization.

2. Sample size used for the test set and the data provenance

• Nanotechnology Test Set: The document mentions testing on "human mesenchymal stem cells (hMSCs) and human osteoblasts (hOBs)." No specific sample size (number of cell cultures, replicates, etc.) is provided in the document.
• Mechanical Testing Test Set: Not specified in terms of number of devices tested; references to ASTM standards imply that standard testing protocols were followed.
• Data Provenance: The in vitro evaluations for the NanoTec surface treatment are implied to be prospective studies conducted by the submitter. For other tests, they were "performed and included" or "referenced in predicate 510(k) submissions," suggesting a mix of new testing and reliance on previously cleared data. Country of origin is not specified, but the submitter is Alphatec Spine, Inc. in Carlsbad, CA, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The non-clinical studies do not involve expert-established ground truth in the context of clinical image interpretation or diagnosis. The ground truth for cellular assays is laboratory-measured biological markers, and for mechanical tests, it's defined by the physical responses measured according to engineering standards.

4. Adjudication method for the test set

Not applicable. There is no human interpretation or adjudication involved in the reported non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an intervertebral body fusion system, not an AI/imaging device, therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a medical implant, not an algorithm.

7. The type of ground truth used

• Nanotechnology Claim: Laboratory measurements of cellular proliferation, alkaline phosphatase activity, and mineralization in cell cultures are used as "ground truth" to assess osteogenic differentiation.
• Mechanical Testing: Physical measurements obtained according to established ASTM standards (e.g., force, displacement, gravimetric changes) serve as the ground truth.

8. The sample size for the training set

Not applicable. There is no machine learning PAI involved, so no training set is used.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, this question is not relevant.

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