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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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Segmental Plating System (SPS)

The Segmental Plating System (SPS) is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

IdentiTi SPS Interbody System

The IdentiTi SPS 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 IdentiTi SPS 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 combination thereof.

IdentiTi NanoTec SPS Interbody System

The IdentiTi SPS 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 SPS 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 combination thereof.

Transcend SPS Interbody System

The Transcend SPS 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, and/ or pain at multiple contiguous levels from C2-T1. The Transcend SPS Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.

Transcend NanoTec SPS Interbody System

The Transcend SPS 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, and/or pain at multiple contiguous levels from C2-T1. The Transcend NanoTec SPS 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 combination thereof.

The Segmental Plating System (SPS) is intended for anterior fixation to the cervical spine. The Segmental Plating System (SPS) consists of a variety of sizes of 2 - 4 holes plates and 3.5 mm and 4.0 mm screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The plate includes a screw anti-backout mechanism. The system will offer instrumentation for the delivery of the plate and screw construct. The instruments in this system are intended for use in surgical procedures. The plate system implants are provided non-sterile to be steam sterilized by the end user.

The IdentiTi and Transcend SPS Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through anterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, commercially pure titanium (CP Ti Grade 2) per ASTM F67, and an optional hydroxyapatite nano (HAMM) surface treatment. The subject system 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 subject IdentiTi and Transcend NanoTec SPS Interbody Systems interbody implant surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents a nano-scale topography on the entirety of the implant surface. in addition to macro-/micro-scale topography existing from prior to HA man treatment. The interbody spacers are provided individually packaged and sterile.

The provided text is a 510(k) summary for a medical device (Alphatec Spine Inc.'s Segmental Plating System and Interbody Systems). It discusses regulatory clearance based on substantial equivalence to predicate devices, outlines the device's description, indications for use, and a technological comparison. It also lists performance data from non-clinical testing.

However, the provided text does not contain information about acceptance criteria for an AI/ML medical device, nor does it describe a study involving a test set, ground truth determination, expert consensus, or human-in-the-loop performance evaluation. The document primarily focuses on the mechanical and material aspects of spinal implants and their equivalence to existing devices, with performance data relating to mechanical testing standards (e.g., ASTM F2077, F2267, F1717).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present. The device in question is a physical implant, not an AI/ML-based diagnostic or therapeutic device.

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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, and/or pain at multiple contiguous levels from C2-T1. The IdentiTi Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems. The system is designed for use with autograft comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.

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, myelopathy, 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 comprised of cortical, cancellous, and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.

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

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 comprised of cortical, cancellous and/or corticocancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.

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 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 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 combination thereof.

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 radioulopathy, myelopathy, 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 cortico-cancellous bone graft, demineralized allograft with bone marrow aspirate, or a combination thereof.

The IdentiTi and Transcend Interbody Systems are cervical intervertebral body fusion systems designed to be inserted through anterior surgical approaches. The interbody spacers are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, tantalum per ASTM F560, titanium alloy (Ti-6A1-4V 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 document provided is a 510(k) Pre-Market Notification for the Alphatec Spine Inc. IdentiTi™ and Transcend™ Interbody Systems. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that a device meets specific acceptance criteria through a study with performance metrics.

The document does not contain the kind of detailed information about acceptance criteria and study results (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that you requested for an AI/ML medical device. Instead, it focuses on non-clinical testing for mechanical properties and material characteristics of an implantable medical device.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes for test/training sets, expert information, adjudication methods, or MRMC study details from this document. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." and "no further clinical or non-clinical testing is required to support the expanded indications for use of the subject systems."

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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 allograft bone with bone marrow aspirate and 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.

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 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 and 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.

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 allograft bone with bone marrow aspirate and 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.

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 and 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.

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 or retrolisthesis 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 in addition to the integrated screws. The IdentiTi 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 with bone marrow aspirate. The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi 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.

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 or retrolisthesis 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 with bone marrow aspirate. 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.

The IdentiTi and Transcend Interbody Systems are 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 (CPT) 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 the treatment of degenerative spondylolisthesis, multilevel degenerative scoliosis, spinal stenosis, and sagittal deformity, and use of allogeneic bone consisting of cortical bone, as well as allogeneic bone consisting of demineralized allograft bone with bone marrow aspirate.

This document pertains to the Alphatec Spine interbody systems (IdentiTi™ Porous Ti, IdentiTi™ NanoTec™, Transcend™ PEEK, Transcend™ NanoTec™, IdentiTi™ ALIF Standalone, and IdentiTi™ NanoTec™ ALIF Standalone Interbody Systems) and their expanded indications for use.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria values (e.g., "device must withstand 1000N axial compression"). Instead, it lists the types of non-clinical tests performed, implying that the devices met the requirements of these standard tests. The reported "performance" is implicitly that the devices passed these tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each non-clinical test (e.g., number of interbody devices tested for axial compression). It refers to the tests generally.

Regarding data provenance, the tests are non-clinical (laboratory tests) and therefore do not involve patient data or data from specific countries of origin. The data is prospective as it was generated specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this submission. The "ground truth" for the non-clinical performance tests is based on established engineering standards (ASTM) and the physical properties of the devices themselves, not on expert medical opinion or consensus.

4. Adjudication Method for the Test Set

This question is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters, where discrepancies in interpretation need to be resolved. The non-clinical tests outlined here are objective measurements against predefined standards.

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

This question is not applicable to this submission. The device is an intervertebral body fusion system, a physical implant, not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant.

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

This question is not applicable to this submission. The device is a physical interbody fusion system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance tests, the "ground truth" is based on engineering standards and material science specifications. The tests are designed to assess the physical and mechanical properties of the interbody systems against recognized benchmarks for safety and effectiveness in their intended use.

8. The sample size for the training set

This question is not applicable to this submission. As the device is a physical implant and not an AI/ML algorithm, there is no "training set."

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

This question is not applicable to this submission for the same reason as above (no training set).

Ask a specific question about this device

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 (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 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.

The IdentiTi Interbody System with advanced NanoTec surface treatment 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 (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondy)olisthesis 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 NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft 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.

The Transcend PEEK 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 (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 Transcend PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft 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.

The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 (DDD), including thoracic disc hemiation (myelopathy with or without axial pain).
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 Transcend NanoTec PEEK 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 allografi 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.

The IdentiTi ALIF Standalone Intern is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of ≥20° are a standalone system. The IdentiTi 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.
The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis 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 ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft.

The IdentiTi ALIF Standalone International NanoTec surface treatment is indicated for spinal fusion procedures in skeletally mature patients. 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.
The IdentiTi NanoTec ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-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 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 for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft

The IdentiTi Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-overative treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft and/or allograft composed of cancellous and/or cortico-cancellous bone graft and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The IdentiTi Cervical Standalone Interbody System with advanced NanoTec surface treatment is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment prior to treatment with the device. The IdentiTi NanoTec Cervical Standalone Interbody System is to be used with autograft and/or allograft composed of cancellous and/or cortico-cancellous bone graft and implanted via an open, anterior approach. The IdentiTi NanoTec Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The IdentiTi and Transcend Interbody Systems are cervical and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and posterior approaches. The interbody spacers are manufactured surgical 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 (CP Ti 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 IdentiTi ALIF and Cervical Standalone Interbody Systems accept two or three bone screws/bolts that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters.

This document is an FDA 510(k) Premarket Notification for various interbody fusion devices. It establishes substantial equivalence to previously cleared predicate devices, arguing that the new devices do not raise new questions of safety or effectiveness. As such, it does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/ML algorithm's performance.

Instead, the document focuses on the mechanical and material properties of the interbody fusion implants. The "Performance Data" section explicitly states "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." and refers to mechanical testing on the predicate devices and Bacterial Endotoxin Testing (BET) for the subject devices.

Therefore, I cannot provide the requested information for an AI/ML study from this document. The information requested (acceptance criteria, sample size for test/training sets, expert qualifications, etc.) would only be relevant if the device involved an AI/ML component whose performance needed to be evaluated against clinical metrics, which is not the case here.

To re-iterate, this document is a 510(k) submission for spinal implants, not for an AI/ML-driven medical device.

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Transcend NanoTec Cervical Platform: The Transcend PEEK Cervical Interbody System with advanced NanoTec surface treatment 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 Transcend PEEK Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft or allograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.

Transcend NanoTec Thoracolumbar Platform: The Transcend PEEK Interbody System with advanced NanoTec surface treatment 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 (DDD), including thoracic disc herniation (myelopathy with or without axial pain). 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 Transcend NanoTec PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft 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. 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.

IdentiTi Porous Ti Interbody System: Intended for spinal fusion procedures at one or two levels from C2-T1 in skeletally mature patients with degenerative 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 Cervical Porous Ti Interbody System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.

IdentiTi Thoracolumbar Platform: 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 (DDD), including thoracic disc herniation (myelopathy with or without axial pain). 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 non-operative treatment. It is intended for use with autograft 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. 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.

Transcend PEEK Interbody System: 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 Transcend PEEK Cervical Interbody System is intended for use with supplemental fixation systems and with autograft (e.g., allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients should have had six weeks of non-operative treatment.

Transcend Thoracolumbar Platform: 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 (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). 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 Transcend PEEK Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous bone graft and 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.

IdentiTi NanoTec Interbody System: 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 Cervical NanoTec Interbody System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.

IdentiTi NanoTec Thoracolumbar Platform: 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 (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). 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 NanoTec Interbody System is intended for use on patients who have had at least six months of non-operative 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. 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.

The IdentiTi and Transcend Interbody Systems are cervical and thoracolumbar intervertebral body fusion systems designed to be inserted through anterior and lateral 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). 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 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 IdentiTi and Transcend Interbody Systems also includes LIF AMP integrated fixation to be used with the LIF interbody offerings. The LIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.

This document is a 510(k) Premarket Notification from the FDA regarding several interbody systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not contained within this document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for device performance (e.g., accuracy, sensitivity, specificity) or "reported device performance" against such criteria are provided in this regulatory document. The document focuses on demonstrating substantial equivalence to predicate devices through technological comparison and nonclinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This document does not describe a study involving a "test set" of patient data for evaluating device performance in terms of diagnostic accuracy or similar metrics. The focus is on demonstrating equivalence through mechanical testing and nonclinical testing for biocompatibility.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. Ground truth establishment by experts is relevant for studies evaluating diagnostic or prognostic algorithms. This document does not describe such a study.

4. Adjudication Method for the Test Set:

Not applicable. As no test set involving expert review is described, there's no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This document does not mention an MRMC comparative effectiveness study or any evaluation of human readers' improvement with or without AI assistance. The devices are interbody fusion systems, not AI-powered diagnostic tools.

6. Standalone Performance Study:

No. This document describes medical devices (interbody fusion systems) and their material properties and intended use, not an algorithm's standalone performance.

7. Type of Ground Truth Used:

Ground truth in the context of this submission is implicitly established through existing regulatory standards and predicate devices. For mechanical testing, the ground truth is adherence to established engineering standards (e.g., ASTM F2026, ASTM F560, ASTM F67, ASTM F136). For nonclinical testing like Bacterial Endotoxin Testing, the ground truth is compliance with relevant standards (ANSI/AAMI ST72:2011/(R)2016).

8. Sample Size for the Training Set:

Not applicable. This document pertains to physical medical devices, not an AI algorithm that would require a training set.

9. How Ground Truth for the Training Set Was Established:

Not applicable. As there is no AI algorithm or training set, this information is not relevant to the document provided.

Summary of Relevant Information from the Document:

The provided document, K211805, is an FDA 510(k) Premarket Notification. It concerns the substantial equivalence of several interbody fusion devices (IdentiTi™ Porous Ti Interbody System, Transcend™ PEEK Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ NanoTec™ Interbody System) to legally marketed predicate devices.

• Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on:

  • Technological Comparison: Comparing intended use, indications for use, design, function, and technology to predicate devices. The document states that the new devices are "substantially equivalent" in these aspects.
  • Nonclinical Testing: Mechanical testing and Bacterial Endotoxin Testing (BET) were performed.
    • Mechanical Testing: Performed on the predicates and deemed applicable to the modified devices because there are "no difference in size, dimension, raw material or manufacturing method or equipment with the exception of a nanometer thin layer of hydroxyapatite applied to the surface." This implies that the mechanical performance (e.g., strength, durability) is considered equivalent to the predicate that has already met its mechanical performance requirements.
    • Bacterial Endotoxin Testing (BET): Performed per ANSI/AAMI ST72:2011/(R)2016. The results demonstrate that the subject systems are substantially equivalent to other predicate devices for nonclinical testing.

• Study That Proves the Device Meets Acceptance Criteria:

  • The study primarily involves a technical comparison and nonclinical laboratory testing. No clinical studies are mentioned.
  • Sample sizes: Not specified for mechanical or BET testing, as these are typically conducted on a limited number of representative samples, not human patient "test sets."
  • Data provenance: Not explicitly stated, but nonclinical testing is typically performed in a controlled laboratory environment (e.g., in the US, where Alphatec Spine is based). This is not retrospective or prospective patient data.
  • Experts: Not applicable for nonclinical lab testing.
  • Adjudication method: Not applicable.
  • MRMC Comparative Effectiveness Study: Not conducted.
  • Standalone Performance: The "standalone performance" is implicitly demonstrated through the nonclinical testing showing compliance with applicable standards and the assertion of substantial equivalence in design and materials compared to already cleared devices.
  • Ground Truth: For mechanical aspects, the ground truth is assumed to be met by the predicate devices adhering to established ASTM standards. For biocompatibility (BET), the ground truth is compliance with ANSI/AAMI ST72:2011/(R)2016.
  • Training Set Sample Size and Ground Truth Establishment: Not applicable as this is not an AI-based device.

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Transcend universal composite is used for direct restorations in both the anterior and posterior regions.

Transcend is a light cured, tooth shade resin composite material (Bis-GMA based) to be used for posterior and anterior tooth restorations. Transcend is radiopaque and available in a range of dentin, enamel, and body shades. It is 81% filled by weight and 58% filled by volume and has an average particle size of 0.9μm (by weight) with narrow upper limit particle distribution.

Composite Wetting Resin is a 45% filled, radiopaque light cured wetting resin. Composite Wetting Resin helps to improve the glide of the instrument during and contouring. It may be used during the placement of composite if the composite has become dry during incremental layering, or if the oxygen inhibition layer has been removed or disturbed. The wetting agent is an accessory and, if necessary, is used in conjunction with Transcend.

This is a medical device 510(k) summary for a dental restorative material, not data from a study that fits the requested format for acceptance criteria of an AI/ML device. Therefore, the requested information elements such as sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth establishment for training and test sets are not applicable or provided in this document content.

The provided text describes a "Transcend" tooth shade resin material and an accessory "Composite Wetting Resin." The document states that "before marketing the device, testing has been conducted to meet specified acceptance criteria." However, it does not provide specific numerical acceptance criteria or the reported device performance in a tabular format that is clearly tied to meeting those criteria, as typically seen for AI/ML device performance studies.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Amelogen Plus) and reference device (SeamFree) through comparisons of technological characteristics, intended use, composition, delivery systems, physical properties, shelf life, and adherence to relevant ISO and ADA standards.

Here's an attempt to extract relevant information, acknowledging that it doesn't align with the typical structure for AI/ML device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against standards, and the results were within acceptable limits. It does not provide specific numerical acceptance criteria or reported values for each property.

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

• Sample Size: Not specified. Standard testing for material properties typically involves multiple samples for reproducibility, but the exact number is not detailed in this summary.
• Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a third-party testing facility.

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

• Not applicable/Not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to established material science standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. The compliance is against defined material property standards, not subjective clinical assessments requiring adjudication.

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 is a dental material, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" in this context is defined by the requirements of the standards: ISO 4049:2019 (Dentistry – Polymer-based restorative materials) and ANSI ADA 27-2016 (Polymer-based Restorative Materials) for physical properties, and ISO 10993-1:2018 for biocompatibility.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device.

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The 'Transcend 365 miniCPAP Auto System' provides positive airway pressure to support treatment of adults over 66 pounds (30 kg) with Obstructive Sleep Apnea (OSA). The device is intended for home and hospital/institutional use. The integrated humidifier provides humidification of air delivered from the Transcend 365 devices. The use of the humidifier is optional.

The Transcend 365 miniCPAP Auto System (Transcend 365) is a new member of Somnetics' family of devices used to treat obstructive sleep apnea which includes the Transcend Auto and Transcend Heated Humidifier devices and accessories cleared via K132127 and K131388. The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events. The Transcend 365 includes the following main modifications:

• Integrated CPAP and humidification system .
• . Modifications from predicate Transcend Auto device
  • Graphic LCD interface vs LED in predicate o
  • Housing design O
• Updated air inlet filter o
• Use of a standard 22-mm connection port for air hose attachment O
• Integrated heated humidifier with water reservoir attached with magnets o
• Integrated humidifier uses Capillary Force Vaporization™ (Vapore) technology ●
  • o Wick to a ceramic heater vaporizes water (instead of continuous heating with a heater plate)
  • Similar to PARI Hydrate V (K072982); same supplier (Vapore) o
  • Allows for a smaller water reservoir and footprint o
    The Transcend 365 is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. When interfaced with a mask though use of a 22 mm breathing hose, this flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. The system provides fixed or auto-adjust pressure from 4 to 20 cmH20 above the ambient atmospheric pressure to a patient's oral/nasal airway.
    The humidifier uses Capillary Force Vaporization technology similar to that used in the PARI Hydrate V (Humidifier, Respiratory Gas (Direct Patient Interface); 868.5450, Product Code BTT) cleared under K072982. Water is drawn from a reservoir by a wick to a ceramic heater, which vaporizes the water resulting in comparable humidification output to the predicate devices. There is no heater plate and the water reservoir is not heated. Several humidification levels are available, with higher settings increasing the amount of water vapor. The humidifier is attached to the lower portion of the PAP through the use of magnets.
    It includes the following components and accessories, which are all single patient reusable:
• . Filter Media
• P10 Battery ●
• Transcend 365 miniCPAP Unit .
• USB cable* ●
• Heater Cartridge .
• Wick
• Reservoir .
• Power supply PSA3 ●
• US 2-prong power cord

Here's a breakdown of the acceptance criteria and study information for the Transcend 365 miniCPAP Auto System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance numbers for the Transcend 365. Instead, it lists the various tests and assessments conducted and states that "Results of tests and assessments did not raise new safety or efficacy questions" and that the device "meets acceptance criteria." It also notes specific performance metrics for some features in the "Substantial Equivalence Comparison" table.

However, based on the provided comparison table and performance data section, we can infer some criteria and the device's meeting of those criteria:

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify sample sizes for specific test sets (e.g., patient data for algorithm testing). The performance data cited are primarily related to general device performance (biocompatibility, electrical safety, mechanical, software validation) rather than a clinical study involving patient data.

• Sample Size: Not explicitly stated for any clinical or patient-related test sets. The tests mentioned are largely bench-top, engineering, and compliance tests.
• Data Provenance: Not applicable in the context of clinical trials/patient data. The data provenance is from various engineering and laboratory testing according to international standards (e.g., ISO, IEC, UL, RTCA).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the summary, as the performance data submitted are primarily for engineering and regulatory compliance rather than clinical efficacy studies requiring expert reader ground truth. The device is a "non-continuous ventilator" (CPAP), whose core function for OSA treatment is well-established, and the submission focuses on demonstrating substantial equivalence to existing cleared devices rather than proving a new clinical efficacy claim through extensive clinical data/expert review.

4. Adjudication Method

Not applicable, as no clinical study requiring a ground truth established by expert adjudication is detailed in this 510(k) summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study is typically done for diagnostic or screening devices to compare human performance with and without AI assistance on a set of cases. The Transcend 365 is a therapeutic device (CPAP), and the submission focuses on its engineering performance and equivalence to predicate devices, not on physician interpretation or diagnostic aid effectiveness.

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

Yes, a standalone performance of the algorithm (e.g., for auto-adjust functionality and AHI measurement) was implicitly done. The document states:

• "The Transcend 365 utilizes the same blower and the same algorithm as the Transcend Auto for respiratory event detection and therapy for sleep disordered breathing events."
• Under "Substantial Equivalence Comparison," for "Algorithm," it explicitly states: "Algorithm is identical to primary predicate" for "Auto-adjust," "AHI Measurement," and "Ramp."
• "Mechanical and Acoustic Testing" included "auto adjust functionality" as a tested parameter.

This indicates that the algorithm's performance, being identical to a previously cleared predicate device, was evaluated, but likely through engineering tests simulating respiratory events rather than a new full-scale clinical trial. The "results of tests and assessments did not raise new safety or efficacy questions" applies to this functionality as well.

7. The Type of Ground Truth Used

For the integrated algorithm's performance (respiratory event detection and therapy adjustment), the ground truth would have been established during the original clearance of the predicate device (Transcend Auto, K132127). For a CPAP device, this typically involves:

• Polysomnography (PSG) data: For validating the accuracy of event detection (apneas, hypopneas) and pressure titration algorithms against direct physiological measurements.
• Bench-top simulation: Using standardized breathing simulation equipment and models to test the device's response to various respiratory patterns and ensure accurate pressure delivery and adjustment.

For non-algorithmic aspects (e.g., biocompatibility, electrical safety, mechanical durability), the ground truth is established by the specifications of the relevant international standards (ISO, IEC, UL, RTCA).

8. The Sample Size for the Training Set

The 510(k) summary provides no information on the sample size for a training set. This is consistent with the nature of the submission, which relies on the algorithm being identical to a previously cleared predicate. Any algorithm training would have occurred during the development of the predicate device (Transcend Auto).

9. How the Ground Truth for the Training Set Was Established

As above, the 510(k) summary provides no information on how the ground truth for an algorithm training set was established. This process would have been part of the original development and clearance of the predicate Transcend Auto (K132127). For sleep apnea algorithms, ground truth for training data would typically involve:

• Expert-scored polysomnography (PSG) studies: A large dataset of sleep study recordings where respiratory events (apneas, hypopneas, RERAs) are manually identified and classified by sleep disorder experts according to established scoring rules (e.g., AASM guidelines). This forms the "ground truth" labels for algorithm development and training.
• Standardized physiological signals: Using calibrated sensors and data from patients or simulations that accurately represent the physiological changes associated with sleep-disordered breathing.

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The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.

Here's a breakdown of the acceptance criteria and study information for the Transcend Auto device, based on the provided text:

Acceptance Criteria and Reported Device Performance

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