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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).

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The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications

Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

Here's an analysis of the provided text regarding the SIRION Lateral Lumbar Interbody Fusion device:

The provided document is a 510(k) summary for the SIRION Lateral Lumbar Interbody Fusion device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria through clinical performance.

Based on the provided text, a table of acceptance criteria and reported device performance for a clinical study to prove performance against specific metrics is not available. The document explicitly states: "No clinical studies were performed."

Instead, the submission relies on non-clinical testing and a comparison to predicate devices to establish substantial equivalence.

Here's what can be extracted from the document regarding testing and comparisons:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Equivalence):

Note: The document only states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices." It does not provide specific numerical acceptance criteria or detailed results from these non-clinical tests.

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

• Test Set Sample Size: Not applicable. No clinical test set was used, as "No clinical studies were performed."
• Data Provenance: The non-clinical testing (FEA and Mechanical) was conducted internally or by a contracted lab for Astura Medical. The data provenance details (e.g., country of origin, retrospective/prospective) are not specified in the summary but would be part of the full 510(k) submission.

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

• Not applicable. No clinical test set was used, and therefore no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical studies were performed."

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

• Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" would be established by validated engineering standards (ASTM F2077, ASTM F2267, etc.) and direct physical measurements and observations during testing (e.g., expulsion force, deformation under load). This is a technical ground truth based on established engineering principles and standardized test methods.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm, as this is a physical medical device. The "training" for this type of device development involves established engineering design principles, material science, and manufacturing processes.

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

• Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary of the K202495 Submission:

This 510(k) clearance for the SIRION Lateral Lumbar Interbody Fusion device is based on demonstrating substantial equivalence to previously cleared predicate devices (Sirion Lateral Lumbar Interbody Fusion K192006, Half Dome K152512, K163481, K172947, K182877, and ATEC ALIF and LLIF Spacer System K182746). The equivalence is supported by non-clinical testing (FEA for static/dynamic compression and shear, subsidence, and mechanical expulsion testing) which showed the new device to be comparable. No clinical studies were performed or required for this 510(k) clearance. The acceptance criteria are therefore implicit in the demonstrated equivalence to existing legally marketed devices and adherence to relevant ASTM standards for mechanical performance.

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The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA.

The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

The Kuros TLIF Cage is an implant interbody fusion surgery and is used to restore intervertebral height and facilitate intervertebral body fusion in the spine. The Kuros TLIF Cage is inserted via a posterior (transforaminal) approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and should be used in combination with supplemental posterior spinal fixation systems, intended for use in the lumbar spine and cleared by the FDA.

The Kuros TLIF cage is a rigid spacer, manufactured from PEEK Optima LT1 per ASTM F2026 to maximize biocompatibility, durability, and robustness. The design includes tantalum markers for imaging and has a hollow geometry, allowing the cage to be packed with grafting material per the indications for use. The Kuros TLIF Cages are available in various lengths, and angle variants to accommodate patient anatomy, and are supplied with their specific instrumentation. The device is intended to be used by orthopedic surgeons or neurosurgeons working in a hospital who are trained to use these devices in the patient population specified in the indications for use. The implants are provided sterile to the hospital.

The provided text describes the Kuros TLIF Cage, an intervertebral body fusion device. It details the device's indications for use, description, and comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance metrics, or a study reporting on these metrics.

The document is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the document regarding the device and its evaluation, but it explicitly states "No clinical data has been presented." and therefore cannot fulfill most of the request:

Device Name: Kuros TLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX

Indications for Use:
The Kuros TLIF Cage is intended for use in intervertebral body fusion of one or two contiguous levels of the lumbar spine (L1 to S1). It is inserted via a posterior approach and designed for use with autograft and/or allograft (cancellous and/or corticocancellous bone graft) to facilitate fusion. It must be used with supplemental posterior spinal fixation systems cleared by the FDA.

It is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Description of the Device:
The Kuros TLIF Cage is a rigid spacer made from PEEK Optima LT1 (ASTM F2026). It includes tantalum markers for imaging and has a hollow geometry to be packed with grafting material. It is available in various lengths and angle variants and is supplied with specific instrumentation. The implants are provided sterile.

Summary of Performance Data (as presented in the document):
The Kuros TLIF Cage conforms to the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007."
Worst-case devices were subjected to mechanical testing, including:

• Static axial compression
• Dynamic axial compression
• Static compression shear
• Dynamic compression shear
• Subsidence testing (according to ASTM F2267)
• Expulsion testing (according to Endolab protocol)

Results: "Results demonstrate comparable (or better) mechanical properties to the predicate devices."

Crucially, the document explicitly states: "No clinical data has been presented."

Given this information, it is impossible to complete a table of acceptance criteria and reported device performance from this document for the requested metrics as clinical performance data is absent. The acceptance criteria here are related to mechanical properties in comparison to predicate devices, not clinical outcomes.

Therefore, for your specific request:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Mechanical): Conformity to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007." and mechanical properties comparable to or better than predicate devices across tested parameters (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion).
   • Reported Device Performance (Mechanical): The Kuros TLIF Cage demonstrated "comparable (or better) mechanical properties to the predicate devices" for the tested parameters.
   • Clinical Performance: Not reported in this document.

2. Sample size used for the test set and the data provenance: Not applicable for clinical data, as "No clinical data has been presented." For mechanical testing, specific sample sizes are not provided, only that "Worst case devices were subjected to mechanical testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as "No clinical data has been presented."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as "No clinical data has been presented."

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, as "No clinical data has been presented" and this device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth would be established by the ASTM standards (ASTM F2077, ASTM F2267) and the Endolab protocol. For clinical performance, no ground truth is discussed as no clinical data was presented.

8. The sample size for the training set: Not applicable, as this is a physical medical device and no clinical "training set" of data is mentioned.

9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

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