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The Proximity Anterior Cervical Plate System 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, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

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, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The subject Alphatec Plating Systems consists of two anterior cervical plate subsystems, Proximity Anterior Cervical Plate System and Segmental Plating System, intended for anterior fixation to the cervical spine. The Alphatec Plating Systems consist of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136. The systems offer instrumentation for the delivery of the plate and screw constructs. The instruments in this system are intended for use in surgical procedures. The Alphatec Plating Systems implants are provided either terminally sterile or non-sterile to be steam sterilized by the end user.

I apologize, but the provided text from the FDA 510(k) clearance letter for the Alphatec Spine Proximity™ Anterior Cervical Plate System does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria for software-based AI/ML devices.

The document details:

• Device Type: Spinal Intervertebral Body Fixation Orthosis (a physical implantable device, not a software/AI device).
• Regulations: Primarily related to medical devices, specifically orthopedic implants.
• Performance Data: Lists non-clinical (mechanical) testing based on ASTM standards (e.g., Static and Dynamic Compression Bending, Static Screw Push-out) and sterilization/packaging validations.
• Substantial Equivalence: Compares the mechanical design and indications for use of the Proximity™ system to predicate physical spinal fixation devices.

Therefore, I cannot extract the information required by your prompts (acceptance criteria table, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device described in this 510(k) clearance letter. The letter pertains to a traditional, physical Class II medical device, not a software-based or AI/ML-driven diagnostic or therapeutic tool.

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The IdentiTi™ II Cervical 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 II 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 II Cervical Interbody System is a cervical intervertebral body fusion system designed to be inserted through an anterior surgical approach. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The IdentiTi II Cervical Interbody System includes the following subsystems: IdentiTi II Cervical and IdentiTi II Cervical Max Contact. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II Cervical implants are offered with a microporous/macroporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing.

The provided FDA 510(k) clearance letter and summary concern the IdentiTi II Cervical Interbody System, which is a medical device for spinal fusion. This document does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device clearances.

The performance data section (VII. PERFORMANCE DATA) specifically lists non-clinical testing for mechanical properties, material properties, and biocompatibility, as is standard for intervertebral body fusion devices. These tests include:

• ASTM F2077 static and dynamic axial compression, compression shear and torsion
• ASTM F2267 static subsidence
• ASTM F1714 gravimetric analysis
• ASTM F1877 particle analysis
• Static push-out
• ASTM F1854 stereological analysis
• Bacterial endotoxin testing per ANSI/AAMI ST72

Since the request is to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" as if it were an AI/ML device, and the provided text explicitly indicates it is a non-AI/ML medical device, I cannot fulfill the request directly with the given input. The information points to a traditional medical device clearance, not an AI/ML one.

To answer your question based on the provided document, I must state that the information requested (acceptance criteria for AI/ML performance, study details for AI/ML, human expert consensus, etc.) is not present because the device described is a physical intervertebral body fusion system, not an AI/ML algorithm.

The document confirms that this device is a Class II medical device (Product Code ODP: Intervertebral Body Fusion Device), and its clearance is based on substantial equivalence to predicate devices through engineering and material testing, not through AI/ML performance evaluation.

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The IdentiTi™ II 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 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 II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

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

The IdentiTi II Interbody System is a thoracolumbar intervertebral body fusion system designed to be inserted through anterior and posterior surgical approaches. The interbody implants are additively manufactured from titanium powder per ASTM F3001 using a powder bed fusion method. The endplates of the interbody implants contain roughened surface features to mitigate the risk of expulsion. Additionally, the IdentiTi II implants are offered with a microporous lattice structure that spans the entirety of the implant and extends to the superior and inferior surfaces of the device for biological fixation. The implants consist of various lengths, widths, heights and lordotic options to accommodate individual patient anatomy. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage. The internal lattice structure provides additional space for graft packing. The IdentiTi II LIF implants may be used with the AMP II anti-migration plate and bone screws. The AMP II plate and bone screws are manufactured from titanium alloy per ASTM F136.

Based on the provided text, the document is a 510(k) clearance letter for a medical device (IdentiTi™ II Interbody System), not a study report proving the device meets specific acceptance criteria based on AI/software performance. Therefore, the information required for a study proving acceptance criteria for a device involving AI or complex algorithm performance is not present in this document.

The document discusses the substantial equivalence of the IdentiTi™ II Interbody System to existing predicate devices based on:

• Intended Use & Indications for Use: Spinal fusion procedures.
• Design, Function, and Technology: Specifically mentions additive manufacturing from titanium powder, roughened surface features, microporous lattice structure, and an anti-migration plate.
• Non-clinical Performance Data: Lists various ASTM standards for static and dynamic mechanical testing, gravimetric analysis, particle analysis, static push-out, stereological analysis, static screw push-out, and bacterial endotoxin testing. These are standard tests for intervertebral body fusion devices, not for AI or software performance.

Since this document is entirely focused on a traditional hardware medical device and its mechanical/biocompatibility testing, it lacks all the requested information pertaining to AI/software acceptance criteria and a study proving those criteria.

Therefore, I cannot fill out the requested table or answer the specific questions about AI/software performance, ground truth, expert adjudication, or MRMC studies.

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Calibrate LTX Interbody System

The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (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 Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate LTX 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. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with LTX bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

Calibrate NanoTec LTX Interbody System

The Calibrate LTX 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 a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/ or thoracic disc herniation (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 Calibrate NanoTec LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Calibrate NanoTec LTX 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. The system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.

Calibrate NanoTec LTX spacers expanded greater than 20° have integrated fixation tabs and must be used with AMP-LTX bone screws in addition to supplemental fixation. Calibrate NanoTec LTX spacers without integrated fixation tabs may be used with AMP-LTX System as integrated fixation in addition to supplemental fixation.

The subject Calibrate LTX Interbody Systems are lordotic expandable thoracolumbar intervertebral body fusion systems designed to be inserted through a lateral or anterolateral surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELD per ASTM F136. The subject Calibrate NanoTec LTX Interbody System interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The Calibrate LTX Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and grit-blast treatment on the bone-contacting endplate surfaces. Certain Calibrate LTX Interbody Systems' offerings also accept fixation bone screws manufactured from titanium alloy per ASTM F136.

The purpose of this Traditional 510(k) is to receive clearance for the new sizes of the modified design of the interbody spacer, including a sterile offering of interbody spacer with hydroxyapatite surface treatment, sterile offering of AMP-LTX anti-migration plate and expanded indications for use for the Calibrate LTX Interbody System, previously cleared in K223611.

This looks like a 510(k) clearance letter and summary for a medical device, specifically the "Calibrate LTX Interbody System" and "Calibrate NanoTec LTX Interbody System". This type of document declares substantial equivalence to predicate devices, meaning it doesn't typically include acceptance criteria or detailed study results for a new device's performance against specific metrics in the way a PMA application or a clinical trial report would.

Here's an explanation based on the provided text:

• No acceptance criteria or study data for the device's performance against predefined metrics are present in this document.
• The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This strongly indicates that a clinical study designed to test the device's performance against specific acceptance criteria (like sensitivity, specificity, accuracy, etc.) was not performed or submitted for this 510(k) clearance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details.

Instead, I can explain why this information is absent in this document and what was used for clearance:

This 510(k) submission relies on "Substantial Equivalence" to previously cleared predicate devices. This means the manufacturer demonstrated that the new device (Calibrate LTX Interbody System) is as safe and effective as a legally marketed predicate device (e.g., NuVasive Thoracolumbar Interbody Systems and NuVasive Attrax Putty - K203714, among others).

The "performance data" section in the document, under "VII. PERFORMANCE DATA", states:

• "An engineering analysis was utilized to determine that no new worst-case implants are being introduced compared to the predicate devices to support clearance of Calibrate LTX Interbody Systems."
• "The engineering analysis demonstrates that the subject Calibrate LTX Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing."

This implies that the clearance was based on:

1. Bench testing and non-clinical performance data: This would typically involve mechanical testing (e.g., static and fatigue strength, expulsion resistance), material characterization, and potentially biocompatibility testing to ensure the device meets established standards and performs comparably to or better than the predicate devices. The document refers to "engineering analysis" and "nonclinical testing" as the basis for demonstrating substantial equivalence. It does not provide specific acceptance criteria or results from these tests in this summary, but they would have been submitted to the FDA.
2. Comparison of technological characteristics: The document explicitly states, "The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function, and technology and it was demonstrated that they are substantially equivalent."

In summary, based on the provided document:

• No acceptance criteria or specific device performance data (like sensitivity, specificity, accuracy for an AI system) are detailed because this is a 510(k) clearance based on substantial equivalence, not a new clinical efficacy study.
• No information on sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for clinical performance is available here. This type of data would be required for devices where clinical performance is a primary metric for safety and effectiveness, often under a PMA pathway or for novel AI/software as a medical device (SaMD) requiring significant de novo clinical validation.

This document focuses on the mechanical and material equivalence of spinal implants to existing ones, rather than the performance of a diagnostic or AI algorithm.

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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 Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.

The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend NanoTec VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.

The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.

The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite 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.

This document is a 510(k) premarket notification for a medical device – the Ascend™ VBR System and Ascend™ NanoTec™ VBR System, which are vertebral body replacement devices. The content focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for FDA clearance.

The provided text does not contain any information about an AI/ML-based device or its performance criteria. The entire document pertains to physical medical devices (spinal implants) and their mechanical, chemical, and biological performance characteristics.

Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document details traditional medical device testing, such as:

• Static and Dynamic Axial Compression per ASTM F2077
• Static and Dynamic Torsion per ASTM F2077
• Static Subsidence per ASTM F2267
• Static Push-out
• Gravimetric Analysis per ASTM F1714
• Particulate Analysis per ASTM F1877
• Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
• Biocompatibility Testing per ISO 10993-1

These tests are standard for evaluating the mechanical and biocompatibility properties of physical implants, not the performance of an AI/ML algorithm.

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The Invictus™ OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniccervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Invictus OCT Spinal is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphates Spine using various rod-to-rod connectors and/or transitional rods.

The purpose of this submission is to add occipital components to the previously cleared Invictus™ CT Spinal Fixation System (K200936). The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.

The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

This is not a medical device that uses AI. This is a spinal fixation system. As such, information regarding acceptance criteria, study details, and AI-specific performance metrics (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for AI) are not applicable or found in the provided document.

The document discusses the regulatory review of a physical medical device. It confirms the device, the Invictus™ OCT Spinal Fixation System, is substantially equivalent to legally marketed predicate devices based on its intended use, indications for use, design, technology, and nonclinical performance data.

Here's the relevant information that is provided:

1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):

2. Sample size used for the test set and the data provenance: Not applicable for this type of nonclinical, physical device testing. The "test set" would refer to the physical devices themselves and the conditions under which they were tested according to ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device mechanical testing is based on established engineering standards and measurements, not expert consensus on diagnostic images.

4. Adjudication method for the test set: Not applicable for this type of nonclinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal fixation system, not an algorithm.

7. The type of ground truth used: For the nonclinical performance data, the "ground truth" is defined by the objective physical measurements and engineering criteria outlined in the ASTM standards (F2706 and F1798).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Invictus Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Invictus Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Invictus Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus Spinal Fixation System is a thoracolumbosacral pedicle screw system designed to be implanted through a posterior surgical approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, commercially pure titanium (CP Ti Grade 2) per ASTM F67 and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus System consists of a variety of shapes and sizes of screws, hooks, rods, connectors, and cross-connectors to create a rigid construct as an adjunct to fusion for temporary internal fixation and stabilization of the thoracic, lumbar and sacral spine.

The purpose of this submission is to add new components to the Invictus Spinal Fixation System.

The provided text describes the 510(k) premarket notification for the Invictus™ Spinal Fixation System. This document is a regulatory submission for a medical device that does not involve Artificial Intelligence (AI). It focuses on demonstrating substantial equivalence to existing predicate devices based on mechanical and material properties, rather than an AI algorithm's performance.

Therefore, the information required to answer your request (acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not present in this document. The document explicitly states:

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

This clarifies that no clinical performance study (which would be the context for AI model evaluation) was conducted for this submission. The "acceptance criteria" discussed are related to the mechanical performance of the spinal fixation system (e.g., ASTM F1717 Dynamic Compression Bending, ASTM F1798 Static Flexion-Extension Moment), not the output of an AI algorithm.

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The Invictus™ OsseoScrew® System (for use with the Invictus™ Spinal Fixation System and the transition rods from the Invictus™ CT Spinal Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Invictus OsseoScrew is a pedicle screw system that consists of pedicle screws and associated general instruments. Implant components are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The subject cannulated polyaxial pedicle screws are in diameters of 6.5 mm and 7.5 mm with lengths ranging from 40 to 55 mm. The Invictus OsseoScrew is designed to be compatible with the Invictus Spinal Fixation System screws, hooks, rods, connectors, and cross-connectors for the thoracolumbar spine and Invictus CT Spinal Fixation System for the cervical (C1 to C7) to thoracic (T1-T3) spine. The Alphatec Spine Invictus OsseoScrew System is an implantable pedicle screw device whose core is manufactured from titanium alloy (Ti-6A1-4V ELI) conforming to ASTM F136 and the expandable screw shank is manufactured from CP2 Titanium conforming to ASTM F67 which are both industry recognized standards.

The device described is the Invictus™ OsseoScrew® System, a pedicle screw system. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study data for device performance against specific acceptance criteria for AI/ML.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. The document pertains to a medical implant and its mechanical performance.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis of the information that can be extracted or inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document discusses nonclinical testing for mechanical properties of the implant, not performance criteria for an AI/ML powered device. The "performance data" section lists mechanical tests according to ASTM standards for spinal implant systems. The "results demonstrate that the subject device is substantially equivalent to other predicate devices for nonclinical testing," implying that the performance met regulatory expectations for substantial equivalence based on these mechanical tests.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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 information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. The device is a physical pedicle screw system, not an algorithm.

7. The type of ground truth used:

Not applicable. For the mechanical testing mentioned, the "ground truth" would be established by the physical properties and failure points observed during the ASTM standard tests, compared against industry standards and predicate device performance. It's not a concept of "ground truth" as used in AI/ML validation.

8. The sample size for the training set:

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

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

Not applicable. This information is relevant for AI/ML studies, not for the mechanical testing of a pedicle screw system described here.

In summary, the provided document does not contain information related to the acceptance criteria or study design for an AI/ML powered medical device. It details a 510(k) submission for a physical medical implant (pedicle screw system) and its nonclinical mechanical testing for substantial equivalence.

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