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The VerteFIT™ Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace collapsed, damaged or unstable vertebral bodies due to tumor or trauma (i.e., fracture). The VerteFIT Corpectomy Cage System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The VerteFIT Corpectomy Cage System device may be used with allograft or autograft. The VerteFIT implants are intended to be used with supplemental spinal fixation systems that have been cleared by FDA for use in the thoracic and/or lumbar spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems).

VerteFIT Corpectomy Cages are vertebral body replacement devices used to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy. The components include central PEEK cores and titanium-coated PEEK endcaps which are available in a range of sizes and options to accommodate the anatomical needs of a wide variety of patients. The core and endcaps can be intraoperatively assembled to best fit patient anatomy requirements. Each endcap has a central axial chamber to allow autogenous bone graft or allograft to be packed inside of the spacer. Unidirectional teeth on the superior and inferior surfaces grip the endplates of the adjacent vertebrae to resist expulsion. VerteFIT endcaps (superior and inferior) have slots to accommodate VerteBRIDGE anchoring plates.

This document describes the VerteFIT™ Corpectomy Cage System, a vertebral body replacement device. The provided text outlines the device's indications for use and non-clinical performance data, but it does not describe an acceptance criteria table, a study proving device adherence to acceptance criteria, nor does it contain information typically associated with studies of AI/ML devices (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The information provided pertains to the non-clinical performance data which focuses on mechanical testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI/ML-specific study details.

Here's a breakdown of the available information based on your request:

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

• Acceptance Criteria: Not explicitly stated in a table format. The document implies compliance with standards and guidance documents, such as "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s., May 3, 2004" and various ASTM standards (F2077, F2267, F2129).
• Reported Device Performance: The document states that "Mechanical testing was conducted... to demonstrate substantial equivalence to the predicate system(s)." Specific numerical performance results or whether these results "met" an explicit acceptance criterion are not detailed in this summary.

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

• Sample Size: Not applicable. The document refers to mechanical testing, not clinical studies involving patient data.
• Data Provenance: Not applicable. No patient data or clinical data is mentioned.

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)

• Not applicable. This is a mechanical device, and "ground truth" as typically understood in AI/ML clinical studies is not relevant. Mechanical testing relies on engineering standards and measurements.

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

• Not applicable. No form of adjudication is mentioned as it's not a clinical study involving human interpretation.

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 document pertains to a physical medical device (spinal implant), not an AI/ML diagnostic or assistive device. No MRMC study or human reader performance is mentioned.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering specifications and performance within defined limits of the ASTM standards mentioned.

8. The sample size for the training set

• Not applicable. There is no AI/ML component; therefore, no training set.

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

• Not applicable. There is no AI/ML component; therefore, no training set ground truth.

Summary of Non-Clinical Performance Data (as provided):

• Tests Conducted:
  • Static & dynamic compression (ASTM F2077)
  • Static & dynamic shear compression (ASTM F2077)
  • Static & dynamic torsion (ASTM F2077)
  • Subsidence (ASTM F2267)
  • Cage and anchor expulsion (F-04.25.05.02)
  • Corrosion testing (ASTM F2129)
• Purpose: To demonstrate substantial equivalence to predicate device(s) based on mechanical performance.
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

This document focuses on the regulatory clearance for a physical medical device through a 510(k) pathway, which typically involves demonstrating substantial equivalence to a legally marketed predicate device, often through non-clinical performance testing and comparison of technical characteristics, rather than extensive clinical efficacy studies or AI/ML performance evaluations.

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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 and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft 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 or allogenic 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 locking pin.

The Avenue T cage is manufactured from PEEK-OPTIMA® LT1 with embedded ASTM F136 titanium alloy radiographic markers and ASTM F2063 wrought nickel-titanium shape memory alloy anchoring plate locking pins. The VerteBRIDGE anchoring plates are manufactured from ASTM F136 titanium alloy.

The Avenue T cages are designed in 30mm and 34mm lengths, 8mm to 19mm heights, and an 11mm width with lordosis angles ranging from 0° to 9°.

This looks like a 510(k) submission for a medical device, specifically an intervertebral body fusion device (Avenue T TLIF Cage). The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, much of the information you've requested regarding AI algorithm performance, ground truth, expert consensus, and reader studies is not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily refers to general performance criteria through mandated ASTM standards and other non-clinical tests. It doesn't present precise numerical acceptance criteria with corresponding performance values in a direct table format as might be seen for an AI algorithm. Instead, it states that the device "is sufficient for its intended use" and "conformance to endotoxin limits."

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

This question is not applicable as there is no "test set" in the context of an AI algorithm or clinical study with human patients used for demonstrating performance in this 510(k) submission. The non-clinical tests would have their own sample sizes (e.g., number of devices tested for mechanical properties), but these are not specified in the summary.

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

This question is not applicable. There is no "ground truth" establishment in the context of medical image interpretation or diagnosis by experts as this submission is for a physical implant device, not a diagnostic AI tool.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as (3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. This submission is for a physical medical device (spinal cage), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This question is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used:

This question is not applicable. For an intervertebral body fusion device, "ground truth" would relate to successful fusion or clinical outcomes, which are not assessed in this non-clinical submission. The "truth" for the bench tests is adherence to engineering specifications and performance standards.

8. The Sample Size for the Training Set:

This question is not applicable. This is not an AI algorithm.

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

This question is not applicable. This is not an AI algorithm.

Summary of Relevant Information from the Document:

• Device Type: Avenue® T TLIF Cage (Intervertebral body fusion device with integrated fixation, lumbar).
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device via non-clinical performance data.
• Performance Data Provided: Non-clinical bench testing, including:
  • Finite Element Analysis
  • Dynamic compressive shear testing per ASTM F2077-11
  • Static anchoring plate expulsion testing
  • Wear testing & debris analysis
  • Corrosion testing
  • Limulus Ameebocyte Lysate (LAL) endotoxin testing
• Conclusion: The non-clinical testing demonstrated that the Avenue T TLIF Cage is sufficient for its intended use, conforms to endotoxin limits, and is substantially equivalent to legally marketed predicate devices.
• Clinical Data: "Clinical testing was not required to demonstrate substantial equivalence." (Page 5)

This document is a typical 510(k) clearance letter and summary for a Class II medical device, relying heavily on engineering and material performance tests rather than clinical trials or AI performance evaluations.

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The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:

• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity.

· Spondylolisthesis,

· Spondylolysis.

· Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,

· Degeneration of the facets with instability,

· Trauma including spinal fractures and/or dislocations.

The FacetBRIDGE® System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion.

Each FacetBRIDGE® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

This document is a 510(k) premarket notification for the FacetBRIDGE® System, specifically for a line extension that includes an additional washer design. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable/provided in this document in the context of device performance as typically defined for new medical devices requiring extensive clinical data.

Here's what can be extracted based on the provided text, and where information is missing:

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

Explanation: The document states that the purpose of the submission is to introduce a line extension and that the non-clinical performance bench testing conducted was to support substantial equivalence. The "performance" described here is in the context of ensuring the new washer design does not negatively impact existing functionality or mechanical strength. No specific quantitative performance metrics (e.g., maximum load, fatigue cycles, specific dimensional tolerances) or their corresponding acceptance thresholds are provided in this summary. Instead, a general statement of compliance or completion of these tests is made.

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

• Test Set Sample Size: Not specified. The document mentions "functional verification study utilizing sawbones" but does not give a sample size (e.g., number of sawbones tested, number of devices tested on sawbones).
• Data Provenance: Not specified. Given it's non-clinical bench testing, geographical provenance is less relevant than for clinical data. The study appears to be proprietary data from the manufacturer (LDR Spine USA, Incorporated). It is a non-clinical, prospective bench study.

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

• Number of Experts: Not applicable/provided. This was a non-clinical bench study. Ground truth in this context would typically refer to objective measurements from engineering tests rather than expert interpretation.

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

• Adjudication Method: Not applicable/provided. This was a non-clinical bench study.

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

• MRMC Study: No. This is not applicable to a non-clinical submission for a spinal implant. It's a physical medical device, not an AI or diagnostic software.

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

• Standalone Performance Study: No. This is not applicable to a physical medical device.

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

• Type of Ground Truth: For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, material standards, and verifiable physical measurements. For example, during dimensional analysis, "ground truth" would be the engineering drawings and metrology results. For endotoxin testing, it would be a validated assay and defined pass/fail criteria.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would involve specific samples for each test type mentioned.

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

• Ground Truth for Training Set Establishment: Not applicable/provided, as there is no "training set."

Summary of Device and Study Context:

This 510(k) submission, K161798 for the FacetBRIDGE® System, is for a line extension (new washer design) to an already cleared device. The regulatory strategy applied here is to demonstrate "substantial equivalence" to a predicate device (K152137), meaning the new design does not introduce new questions of safety or effectiveness. For such a submission, extensive de novo clinical trials are often not required. The clinical performance data section explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." The non-clinical data primarily consists of engineering analysis, functional verification using sawbones, and endotoxin testing, which are standard for changes to mechanical devices to confirm continued safety and performance without needing full clinical re-validation.

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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 InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device intended for single-level use only in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

• . Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Trauma (fracture or dislocation) .
• . Tumor
  The InterBRIDGE® system is not intended for stand-alone use.

The InterBRIDGE® System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion.
The system is implanted via a posterior approach to the spine. The InterBRIDGE® System includes various sizes of titanium plate constructs. The implants are provided sterile and single use. The instrumentation is non-sterile and reusable.

This 510(k) summary describes a medical device, the InterBRIDGE Interspinous Posterior Fixation System, which is a physical implant, not an AI/software device. Therefore, the typical acceptance criteria and study designs relevant to AI devices (such as those involving sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable here.

Instead, this document focuses on the mechanical and material performance of the physical implant to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information, framed within the context of a physical medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to mechanical and material properties, and "reported performance" indicates that the device met these criteria. The document states that the testing demonstrated sufficient strength and substantial equivalence to predicates. Specific numerical acceptance criteria are not explicitly listed in this summary but would be detailed in the full submission.

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

• Sample Size: Not applicable in the context of an AI/software device. For a physical device, this refers to the number of test articles (implants) subjected to mechanical testing. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of an AI/software device. For a physical device, the data provenance relates to the testing facility and the standards followed (e.g., ASTM F1717-12a).

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

• Not applicable. This question pertains to subjective assessments or diagnostic interpretations typically associated with AI/software performance. For a physical implant, ground truth is established through objective, quantifiable mechanical tests against established engineering standards.

4. Adjudication Method for the Test Set

• Not applicable. This question is relevant to situations where multiple human readers or classifiers make subjective judgments that need to be resolved. Mechanical testing of a physical device does not involve adjudication.

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

• No, not applicable. This type of study is specifically designed for AI-assisted diagnostic tools that involve human readers. The InterBRIDGE system is a physical surgical implant.

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

• No, not applicable. This concept applies to AI algorithms. The InterBRIDGE system is a physical implant.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Objective Mechanical Testing Standards: Performance against established ASTM (American Society for Testing and Materials) standards (modified ASTM F1717-12a) for spinal implants. These standards define the expected biomechanical behavior for such devices.
• Comparison to Predicate Devices: The key "ground truth" for substantial equivalence is the
  demonstrated performance being comparable (equivalent) to legally marketed predicate devices that have already been deemed safe and effective.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for a physical medical implant in the way there is for an AI algorithm. Design and development are based on engineering principles and preclinical testing, not machine learning training data.

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

• Not applicable. As there is no training set in the AI sense, this question is not relevant. The design and validation of the InterBRIDGE system relied on established engineering principles, material science knowledge, and biomechanical testing methods rather than ground truth data for training.

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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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