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The Avenue® T TLIF Cage system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Avenue T TLIF Cage is designed for use with or without integrated fixation and must be used in conjunction with supplemental fixation cleared by FDA for use in the lumbar spine. The device is implanted via a transforaminal approach and intended for use with autograft to facilitate fusion.

The Avenue T TLIF (Transforaminal Lumbar Interbody Fusion) Cage system is comprised of various size interbody cages, integrated fixation anchoring plates (VerteBRIDGE® Plating), and associated instrumentation. The Avenue T cage is intended for use as an intervertebral body fusion cage in the anterior column of the lumbar spine. The Avenue T cage is designed to be implanted obliquely via a transforaminal approach. The cages feature rows of uni-directional teeth on the superior and inferior surfaces to aid stability and a tapered bullet-shaped tip to ease insertion. The Avenue T cages have a hollow central cavity to contain autogenous bone graft for fusion.

After cage placement, the VerteBRIDGE integrated fixation anchoring plates may be inserted into the cage to provide further stability and fixation. The VerteBRIDGE anchoring plates pass through the cage via slots and lodge firmly into the superior and inferior vertebral endplates. The VerteBRIDGE anchoring plates lock into the Avenue T cages via an integral titanium locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in a variety of length, and lordosis combinations to best fit varying patient anatomies.

The provided text describes a medical device (Avenue T® TLIF Cage) and its FDA clearance. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance, which is what your request is focused on. This document is a 510(k) summary for a physical medical implant, not an AI or software as a medical device.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and study particulars for AI-related performance. The document explicitly states:

• "Clinical testing was not required to demonstrate substantial equivalence." This means no human clinical trials were performed to assess patient outcomes or the device's clinical effectiveness in a real-world setting.
• "Non-clinical performance bench testing conducted to support substantial equivalence for the Avenue T TLIF Cage included: ... The results of this non-clinical testing demonstrate that the strength of the Avenue T TLIF Cage is sufficient for its intended use and is therefore substantially equivalent to legally marketed predicate devices." The "acceptance criteria" here refer to engineering and biomechanical tests comparing the device to existing predicate devices, not performance against clinical endpoints or AI metrics.

The information you are asking for, such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, and ground truth types, are standard for AI/software medical devices undergoing regulatory review, but are not applicable to the documentation provided for this physical implantable device.

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The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine:

• 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 .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• . Tumor
• Pseudoarthrosis .
• Failed previous fusion ●

The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system consisting of various implant components. The 4.25 mm pedicle screws and curved rods represent a line extension to the previously cleared Easyspine Spinal System (K043094, K063794, and K082592). The subject devices are identical to their predicates with respect to general technological characteristics and intended use.

The provided document describes the LDR Spine Easyspine Posterior Spinal System, a medical device for spinal fixation. However, the document does NOT contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria in terms of clinical or algorithm performance.

Instead, the document focuses on:

• Device Description: The Easyspine Spinal System is a side-loading posterior spinal pedicle fixation system. The K123134 submission is for a line extension of 4.25 mm pedicle screws and curved rods to an existing system.
• Indications for Use: The system is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion for various spinal instabilities.
• Non-Clinical Testing: This section states that non-clinical testing was performed on the proposed 4.25 mm pedicle screws in accordance with ASTM standards (F-1717 and F-1798) for static and dynamic axial compression, static torsion, axial gripping capacity, and flexion-extension cantilever.
• Conclusion: The non-clinical testing results demonstrate that the performance of the proposed LDR Spine Easyspine implants is "substantially equivalent" to their legally marketed predicates. This is the basis for the FDA's 510(k) clearance, which is a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria for device performance and a study proving those criteria are met for a clinical or software-based outcome. The document describes a non-clinical (benchtop) study designed to demonstrate substantial equivalence to predicate devices based on mechanical performance standards, not a study evaluating human-in-the-loop performance, standalone algorithm performance, or using human expert ground truth.

If this were a submission for a software-as-a-medical-device (SaMD) or AI-based device, the requested information would be pertinent. However, for this spinal implant submission, the "study" is the non-clinical mechanical testing, and the "acceptance criteria" are implicitly defined by the chosen ASTM standards and the demonstration of substantial equivalence to predicate devices, rather than a quantifiable clinical performance metric.

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The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine:

• 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
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

When used as an intervertebral body fusion device, the MC+ Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with the device. The MC+ Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation is required to properly utilize this system.

When used as a vertebral body replacement device. the MC+ Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.

The ROI Partial Vertebral Body Replacement System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. ROI Partial Vertebral Body Replacement implants may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize the system.

When used as an intervertebral body fusion device. the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The ROI-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

When used as an intervertebral body fusion device, the ROI-T Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.

The ROI-T implants may be implanted singularly or in pairs.

The LDR Spine implant systems identified above are medical devices designed to stabilize and promote fusion in the cervical and thoracolumbar spine. The materials used in their manufacture are titanium alloy (ASTM F136), tantalum (ASTM F560), and PEEK OPTIMA® LT1.

The purpose of this 510(k) submission is solely to add MR Conditional labeling to LDR Spine's vertebral body replacement and interbody fusion cage systems (ROI, MC+, ROI-A, ROI-C, ROI-T), and to update the steam sterilization recommendations for all non-sterile instruments, cases, and trays for the above listed vertebral body replacement and intervertebral body fusion cages, as well as the Easyspine pedicle screw system.

The subject device systems remain unchanged relative to their predicates with respect to indications for use, material, design and performance characteristics.

The provided text is a 510(k) Summary for LDR Spine USA devices, specifically focusing on adding MR Conditional labeling and updating steam sterilization recommendations. It does not describe the acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based diagnostic or prognostic device.

Instead, the document details non-clinical performance data for MR compatibility and sterilization validation for physical implant systems.

Therefore, I cannot extract the requested information as it pertains to AI/algorithm-based device performance. The document focuses on:

1. MR Compatibility Testing:

   • Acceptance Criteria (Implied): Meeting ASTM recommendations for MR-Conditional labeling in terms of device heating, magnetically induced displacement, and MRI artifacts.
   • Study: Non-clinical performance testing conducted on ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants.
   • Methods: Described in ASTM F2052-06, ASTM F2213-06, ASTM F2119-07, and ASTM F2182-09.
   • Reported Performance: Test results indicate that the PEEK interbody fusion cages and anchor plates (where applicable) and vertebral body replacement devices meet these ASTM recommendations.

2. Steam Sterilization Validation:

   • Acceptance Criteria: Achieving a Sterility Assurance Level (SAL) of 10^-6 (although the document states 10^-8, which is an even higher level of assurance) when exposed to a steam sterilization cycle meeting recommended parameters.
   • Study: Steam sterilization validation for non-sterile devices associated with the EasySpine pedicle screw system and the ROI, MC+, ROI-A, ROI-C, and ROI-T implants.
   • Methods: Performed in accordance with AAMI TIR12, ANSI AAMI ST79, ISO 17655-1, and AAMI TIR 39.
   • Reported Performance: Confirmed that the non-sterile devices achieved a SAL of 10^-8.

Regarding the specific points of your request for an AI/algorithm device:

1. Table of acceptance criteria and reported device performance: Not applicable to this document's content.
2. Sample size for the test set and data provenance: No test set in the context of AI/algorithm is described. The tests were on physical implant samples.
3. Number of experts and their qualifications: Not applicable. Testing involved engineering and lab evaluations.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. This document is not about human reader performance with or without AI.
6. Standalone performance study: Not applicable. This refers to the physical properties of the implants, not an algorithm's standalone performance.
7. Type of ground truth used: Not applicable in the AI/algorithm sense. The "ground truth" for MR compatibility is adherence to ASTM standards and for sterilization is achieving a specific SAL.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

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The Avenue® L Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation (e.g. pedicle screws). The device system is intended to be used with autograft to facilitate fusion.

The Avenue L Interbody Fusion System is intended for use as an interbody fusion device in the lumbar spine. The device consists of intervertebral cages manufactured from medical grade PEEK OPTIMA® LT1 (ASTM F2026) with embedded titanium alloy markers (ASTM F136) to facilitate visibility in x-ray imaging. The Avenue L is available with VerteBRIDGE titanium alloy anchoring plates which facilitate fixation to the superior and inferior vertebra, in addition to supplemental fixation. The Avenue L is designed for placement using a lateral surgical approach.

The provided text describes the LDR Spine Avenue® L Interbody Fusion System, an intervertebral fusion device. No information about AI/ML device acceptance criteria or studies involving AI performance, human readers, or ground truth establishment for AI models is present in the document.

The document mainly focuses on the regulatory submission (510(k) summary) for a medical device and describes its intended use and conformance to established standards.

Therefore, I cannot fulfill the request for information on acceptance criteria and studies proving an AI device meets those criteria. The provided text does not describe an AI/ML device.

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The SpineTune™ TL Spinal System is a posterior, non-cervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

• Spondylolisthesis (Grade 3 and 4) .
• Degenerative spondylolisthesis with objective evidence of neurological . impairment
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, . kyphosis, and/or lordosis)
• Tumor .
• Pseudoarthrosis .
• Failed previous fusion .

The SpineTune TL Spinal System is a top-loading posterior spinal pedicle fixation system consisting of various pedicle screws, rods, set screws, and transverse, lateral, axial, and domino type connectors. The 8.0mm and 8.5mm polyaxial screws are a design modification of the 8.0mm and 8.5m polyaxial screws cleared in the predicate SpineTune TL Spinal System (K100575, K102331). Cannulated 8.0mm and 8.5mm polyaxial screws, additional lengths of 7.5mm polvaxial, monoaxial, and reduction screws and curved rods, and several device specific instruments, are additions to the previously cleared SpineTune TL Spinal System.

The provided text describes a 510(k) summary for the LDR Spine USA SpineTune TL Spinal System, focusing on mechanical non-clinical testing for substantial equivalence to a predicate device. It does not contain information about the performance of an AI/ML powered device, or any clinical study involving human readers or AI assistance. Therefore, it is impossible to answer the questions related to AI/ML device performance, human readers, or ground truth establishment based on the provided input.

However, I can extract information related to the acceptance criteria for the mechanical tests:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the study:
The study involved non-clinical mechanical testing of the modified 8.0mm and 8.5mm diameter polyaxial screws of the SpineTune TL Spinal System. The purpose was to demonstrate substantial equivalence to the predicate SpineTune TL Spinal System (K100575, K102331). The specific tests performed were Dynamic Compression Bending, Flexion-Extension Cantilever, Axial Gripping Capacity, Overtightening, and Static Torsion, all conforming to relevant ASTM standards. The conclusion was that the device met the acceptance criteria and performed as well or better than the predicate device.

Information not available in the provided text:

• 2. Sample sized used for the test set and the data provenance: The document does not specify the number of samples used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or provided as it is non-clinical mechanical testing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML powered device, and no "ground truth" in the context of expert review is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML powered device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML powered device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the performance standards and criteria set by the predicate device and relevant ASTM standards.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML powered device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML powered device.

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The LDR Spine Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Cervical Interbody Fusion System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

The ROI-C Lordotic implant is an extension of the currently cleared ROI-C cervical interbody fusion system and is intended for use as an interbody fusion device in the cervical spine. The device is manufactured from medical grade PEEK OPTIMA® LT1 in accordance with ASTM F2026 and has tantalum markers conforming to ASTM F136 embedded in the implant extremities to facilitate visibility in x-ray imaging. The subject device is designed for placement using an open anterior approach.

The provided 510(k) summary describes a spinal interbody fusion device, not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable and cannot be extracted from this document.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria, based on the non-clinical testing performed for this type of medical device.

Acceptance Criteria and Device Performance for Non-AI/ML Medical Devices (Spinal Interbody Fusion System)

Study Description (for a Non-AI/ML device):

• Study Type: Non-clinical bench testing, specifically Finite Element Analysis (FEA) and physical testing simulating relevant loads.
• Proof of Meeting Criteria: The results of the non-clinical testing (Finite Element Analysis) demonstrated that the mechanical performance of the ROI-C Lordotic implant, under static axial compression and static axial torsion, was "substantially equivalent" to its legally marketed predicate devices. "Substantial equivalence" is the regulatory standard for 510(k) clearances, meaning the new device is as safe and effective as a legally marketed device.

Information Not Applicable or Not Available from the Provided Text (as this is not an AI/ML device):

1. Sample size used for the test set and the data provenance: Not applicable for non-clinical bench testing of a spinal implant in the context of an AI/ML study. Data provenance (country, retrospective/prospective) also not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert human assessment.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For this device, the "ground truth" for proving substantial equivalence relates to the mechanical properties and biocompatibility of the materials and design, compared against established standards (e.g., ASTM F2077) and the performance of predicate devices. This is not "expert consensus, pathology, or outcomes data" in the AI/ML context.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

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