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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 Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 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. Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate CCX 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 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 lumbar spine.

The Calibrate CCX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 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. Additionally, the Calibrate Nanotec CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec CCX 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 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 lumbar spine.

The Calibrate PSX Interbody System is indicated for spinal fusion procedures from L1 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. Additionally, the Calibrate PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate PSX 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 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 lumbar spine.

The Calibrate PSX Interbody System with advanced NanoTec surface treatment is indicated for spinal fusion procedures from L1 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. Additionally, the Calibrate Nanotec PSX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate NanoTec PSX 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 allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograff bone with bone marrow aspirate and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.

The subject Calibrate Interbody Systems (inclusive of Calibrate CCX Interbody System, Calibrate NanoTec CCX Interbody System, Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System) are expandable lumbar intervertebral body fusion systems designed to be inserted through a posterior or transforaminal surgical approach. The interbody spacers are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and Polyetheretherketone (PEEK) Optima LT1 per ASTM F2026. The Calibrate Interbody Systems consist of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create parallel 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. The subject Calibrate NanoTec Interbody Systems interbody implant endplate surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the endplate surface, in addition to macro-/micro-scale topography existing from prior to treatment.

This document is an FDA 510(k) clearance letter for the Calibrate Interbody Systems. The purpose of this type of submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This process typically relies heavily on bench testing (non-clinical performance data) and comparison of technical specifications, rather than clinical studies involving human subjects or AI performance metrics.

Therefore, the requested information about acceptance criteria, study methodologies, expert ground truth establishment, MRMC studies, standalone AI performance, and training/test set details for proving device performance are not present in this document. This letter confirms the device's substantial equivalence based on non-clinical testing, primarily mechanical performance, and comparisons to predicate devices.

Here's a breakdown of why each point cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document mentions standard ASTM tests (ASTM F2077, ASTM F2267) and static push-out. It states "The results demonstrate that the subject Calibrate Interbody Systems are substantially equivalent to other predicate devices for nonclinical testing," but does not list specific numerical acceptance criteria or performance values.

2. Sample sizes used for the test set and the data provenance: Not applicable in the context of device approval based on substantial equivalence and non-clinical testing. The "test set" here refers to physical devices or materials undergoing mechanical stress tests, not patient data for an AI/algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI or diagnostic devices, is established by human experts (e.g., radiologists, pathologists). This document refers to the mechanical performance of an interbody fusion device, where "ground truth" would be established by engineering standards and measurements, not medical expert consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical studies or expert reviews of data/images to resolve discrepancies or establish a definitive "ground truth." This is not relevant for non-clinical, mechanical 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 conducted. MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices where human readers are involved. This device is an implantable interbody fusion system, not a diagnostic imaging or AI-based device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the conventional sense. For mechanical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM) and physical measurements.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."

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

In summary, this FDA 510(k) clearance is based on the substantial equivalence of the Calibrate Interbody Systems to legally marketed predicate devices, supported by non-clinical performance data primarily demonstrating mechanical integrity and adherence to standardized testing protocols (e.g., ASTM F2077, ASTM F2267). The document explicitly states this in the "PERFORMANCE DATA" and "CONCLUSION" sections. The questions posed are highly relevant for AI/ML-based medical devices or diagnostic tools, but not for traditional implantable devices like the one described here.

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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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The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral fixation in skeletally mature patients as an adjunct to 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, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Invictus® Small 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® Small Stature 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® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.

The Invictus® Small Stature Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The Invictus® Small Stature Spinal Fixation system is compatible with Arsenal® Spinal Fixation System and Invictus® Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods. The Invictus® Small Stature Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and cross connectors that provide internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and cross connectors are manufactured from surgical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The rods are available in commercially pure titanium (CP Ti Grade 4) per ASTM F67, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, and cobalt chrome (Co-28Cr-6Mo) per ASTM F1537.

The Invictus® Small Stature 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 non-sterile to be cleaned and sterilized by the end user. The instruments in this system are intended for use in surgical procedures.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Invictus® Small Stature Spinal Fixation System:

Summary of Device and Context:

The Invictus® Small Stature Spinal Fixation System is a medical device intended for non-cervical posterior and anterolateral fixation in skeletally mature patients and pediatric patients with certain spinal conditions, as an adjunct to fusion. It consists of various components like rods, screws, and connectors, made from surgical grade titanium alloy, commercially pure titanium, and cobalt chrome.

The document is an FDA 510(k) clearance letter, meaning the manufacturer, Alphatec Spine, Inc., is seeking to demonstrate that their new device is "substantially equivalent" to already legally marketed predicate devices, rather than requiring a full Premarket Approval (PMA) application. This typically means the focus of the performance data is on showing comparable safety and effectiveness, often through non-clinical (mechanical) testing, rather than extensive clinical trials with human subjects.

Acceptance Criteria and Device Performance

The provided document does not detail specific numerical acceptance criteria for a study involving AI or software. Instead, it focuses on the substantial equivalence of a physical medical device (spinal fixation system) through non-clinical (mechanical) testing.

Therefore, the "acceptance criteria" here are implied to be the successful demonstration that the Invictus® Small Stature Spinal Fixation System performs comparably to its predicate devices in various mechanical tests, within established industry standards. The reported device performance is that it met these standards.

Table of Acceptance Criteria and Reported Device Performance (as inferred):

The study described is a non-clinical, mechanical performance study, not a clinical study involving human patients or an AI/software assessment. As such, many of the typical questions for AI/software evaluations (sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance of an algorithm) do not apply to this specific document.

Information Not Applicable / Not Provided in the Document:

Given this is a physical device clearance (spinal fixation system) based on substantial equivalence through non-clinical testing, the following points are not applicable (N/A) or not detailed in this 510(k) summary:

1. Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): N/A, as this refers to mechanical testing, not a data-driven clinical or AI study. The "test set" would be the physical prototypes or samples of the device tested in a lab. The "data provenance" would relate to the manufacturing location and testing lab.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Mechanical testing relies on standardized ASTM methods, not expert interpretation of outputs or images.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Not relevant for mechanical testing.
4. 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: N/A. This is a study design for evaluating software/AI in a clinical context, which is not what this 510(k) addresses.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. There is no algorithm mentioned in the context of this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. Ground truth for mechanical testing is derived from the physical properties and performance measured by the specified ASTM standards.
7. The sample size for the training set: N/A. There is no AI/software component, hence no training set.
8. How the ground truth for the training set was established: N/A. No training set for AI/software.

In conclusion: The provided FDA 510(k) document pertains to the clearance of a physical medical device (spinal fixation system) based on a demonstration of substantial equivalence to predicate devices through non-clinical (mechanical) performance data, as per ASTM standards. It does not involve AI, software, or clinical efficacy studies as would be the case for new diagnostic or interpretation tools.

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The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery.

The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures. The IntraOp Alignment System is intended for use with patients aged 18 years and older.

The subject IntraOp Alignment (IOA) System consists of an optical tracking sensor, touchscreen computer, a mobile cart (stand) including an extension arm, and an electronics box with frame grabber, ports for video cables, power cables and external storage devices.

The subject IntraOp Alignment System is a software-based system that from one end interfaces with a mobile C-arm fluoroscope through a video cable and a frame capture device to receive fluoroscopic images as they are acquired, and from the other end connects to an optical position tracking sensor to track the position and orientation of a C-arm in real-time. By using subject IntraOp Alignment System along the side of mobile C-arm fluoroscopy equipment, the user of the system can combine multiple fluoroscopic images, as they are being acquired, into stitched long bi-planar radiographic images for intraoperative visualization and assessment. The user is required to identify the location of the spine in both bi-planar views to scale the image content and provide information regarding the depth of the operative anatomy. The user can then use the measurement tools available on the subject IntraOp Alignment System to visualize and assess the spinal alignment for intraoperative planning of the surgical procedure.

The subject IntraOp Alignment System has an optional capability to connect to a hospitalprovided Wi-Fi to import pre-operatively planned alignment parameters from an Alphatec cloud database. The subject IntraOp Alignment System also has the capability to export the post-operative alignment parameters to the cloud database.

The subject IntraOp Alignment System sits outside the sterile field and is provided non-The subject device is intended for use by trained healthcare professionals, and sterile. appropriately trained clinical and non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by trained non-clinical personnel.

The provided document is a 510(k) summary for the Alphatec Spine, Inc. IntraOp Alignment System. It describes the device's indications for use, technological comparison to predicate devices, and performance testing. However, it explicitly states: "Determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the document does not provide details about a study evaluating the device's performance against clinical acceptance criteria. It mentions "Verification testing to confirm that the system meets the accuracy specifications" and "Verification testing to verify that the following features: image stitching, C-arm tracking and spinal alignment measurements meet performance specifications" as nonclinical performance tests.

Given this limitation, I cannot provide a complete answer to all parts of your request. I will provide the information that is available in the document.

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

The document mentions that nonclinical performance testing was conducted to confirm the system meets accuracy specifications for image stitching, C-arm tracking, and spinal alignment measurements. However, it does not provide the specific numerical acceptance criteria or the reported device performance metrics from these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. As the document explicitly states that substantial equivalence is not based on clinical performance data, it likely refers to technical verification testing on phantoms or simulated data, but the details of such test sets are not included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. The document explicitly states that "Determination of substantial equivalence is not based on an assessment of clinical performance data."

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

The document refers to "nonclinical performance testing" which included "Verification testing to confirm that the system meets the accuracy specifications" and "Verification testing to verify that the following features: image stitching, C-arm tracking and spinal alignment measurements meet performance specifications". While these tests would assess the algorithm's performance, the document does not explicitly state whether this was a standalone (algorithm only) evaluation versus an integrated system test. It mentions the "IntraOp Alignment System" which includes software and hardware components.

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

The document does not specify the type of ground truth used for its nonclinical performance testing.

8. The sample size for the training set

The document does not provide information on a training set, as it primarily focuses on device comparison for substantial equivalence rather than AI/machine learning model development specifics.

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

The document does not provide information on a training set or how its ground truth was established.

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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

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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 ATEC Posterior Navigated Disc Prep Instruments are indicated to facilitate discectomy, bony resection, implant selection, and access during spinal surgery. Navigated instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ATEC Posterior Navigated Disc Prep Instruments are surgical instruments that are designed to be compatible with the Medtronic® StealthStation™ Surgical Navigation System. The navigated disc preparation instruments are intended to facilitate discectomy, and bony resection. The navigated trials are intended to facilitate implant size selection of Alphatec intervertebral body fusion devices during spinal surgery. All instruments are reusable and are offered non-sterile to be cleaned and steam sterilized by the end user.

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) summary for the "ATEC Posterior Navigated Disc Prep Instruments."

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample size used for the test set in the performance testing. It generally states that "Dimensional analysis of the instruments compared to Medtronic instruments" and "Testing to confirm performance and safety of the subject instruments when used with Medtronic StealthStation System" were conducted.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of performance testing for medical devices, it would generally be prospective testing conducted in a controlled environment to verify design specifications and system compatibility.

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

This information is not provided in the document. For device performance testing, "ground truth" might refer to engineering specifications, established performance benchmarks for predicate devices, or validated measurement techniques. The document does not detail how these "truths" were established or if specific experts were involved in defining them.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. "Adjudication method" typically refers to how discrepancies in human reader interpretations are resolved, which is relevant for studies involving human assessment (e.g., diagnostic image interpretation). This document describes performance testing of surgical instruments and their compatibility with a navigation system, not human interpretation of medical data.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a set of navigated surgical instruments intended to facilitate discectomy, bony resection, and implant selection, not an AI-assisted diagnostic tool that aids human readers. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this device.

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

This is not applicable in the typical sense of an algorithm. The device is a set of physical surgical instruments designed to be used with a navigation system. The "performance" being evaluated is the physical and functional interaction of the instruments with the navigation system, not an algorithm's standalone diagnostic capability. The closest analogy might be the performance of the navigation system itself (which the instruments are compatible with), but the document focuses on the instruments' performance and safety when used with that system.

7. The Type of Ground Truth Used

For dimensional analysis, the ground truth would be engineering specifications and drawings for the instruments. For performance and safety with the navigation system, the ground truth would involve defined functional and safety criteria based on the intended use and established performance of the Medtronic StealthStation System. This might include measurements of accuracy, precision, and successful navigation outcomes in a simulated or controlled environment. It is not expert consensus, pathology, or outcomes data in the usual clinical trial sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The development and testing of these surgical instruments do not involve a "training set" in the context of machine learning or AI models. Performance testing of physical medical devices relies on engineering principles and validation against specifications, not data-driven training.

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

This information is not applicable, as there is no "training set." The performance of the instruments is validated against established specifications and functional requirements as described in point 7.

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