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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion 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 vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The Lanx Fusion System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The implant has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The purpose of this submission is to expand the available plate options for the Lanx Lateral-SA implants. The Lanx Fusion System is provided non-sterile.

Here's an analysis of the provided text regarding the Lanx Fusion System, focusing on acceptance criteria and study details.

Based on the provided {0}-{5} text, this is a 510(k) summary for a spinal implant (Lanx Fusion System) seeking FDA clearance. The document describes the device, its intended use, and claims substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria or a study that "proves the device meets the acceptance criteria" in the way a clinical study for an AI/CADe device would.

Instead, the "Performance Data" section specifically refers to bench testing and engineering analysis performed to demonstrate substantial equivalence for a medical device implant. It evaluates mechanical properties of the implant, not diagnostic accuracy in interpreting medical images or data.

Therefore, many of your requested points regarding AI/CADe system evaluation metrics (such as test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device submission.

Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria	Reported Device Performance
   Compliance with ASTM F2077 (static/dynamic compression, static compression shear, static torsion)	"In all instances, the modified device met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F2077). Specific numerical performance values are not provided nor are the specific acceptance thresholds for these tests in this summary. Instead, it states the device met or exceeded the predicate device's performance.
   Compliance with ASTM draft expulsion testing standard Z8423Z (expulsion tests)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with Z8423Z). Specific numerical performance values are not provided.
   Compliance with ASTM F1877 (wear debris)	"...met or exceeded predicate device performance, functioned as intended..." (Implies compliance with F1877). Specific numerical performance values are not provided.
   Substantial Equivalence to predicate device (K123767)	"The modified Lanx Fusion System implants... have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Lanx Fusion System devices (K123767). The minor differences... do not raise any new issues of safety or effectiveness. Performance data presented also demonstrated comparable properties..."

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

   • Not Applicable / Not Provided. This document describes mechanical bench testing of an implant, not a clinical study involving a "test set" of patient data in the typical sense. The "performance testing" refers to physical tests on the device itself.

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 / Not Provided. Ground truth by medical experts is relevant for diagnostic devices or AI systems. This is an implant, and its performance is evaluated physically against engineering standards.

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

   • Not Applicable / Not Provided. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations. This is not a clinical 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

   • Not Applicable / Not Provided. MRMC studies are specifically for evaluating diagnostic performance, often for AI/CADe systems. This device is an implant for spinal fusion and replacement, not a diagnostic tool or an AI system.

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

   • Not Applicable / Not Provided. This concept applies to AI algorithms. The Lanx Fusion System is a physical medical implant.

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

   • Not Applicable. The "ground truth" for this device's performance would be the established engineering standards (ASTM F2077, ASTM draft Z8423Z, ASTM F1877) and the performance characteristics of its predicate device.

8. The sample size for the training set

   • Not Applicable / Not Provided. This is a physical implant, not an AI system that requires a "training set."

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

   • Not Applicable / Not Provided. As above, this is not an AI system. "Ground truth" for its design and manufacturing would come from engineering specifications, material properties, and regulatory standards.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior, approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone grafi in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplemental fixation. The Lanx Lateral-SA implants are to be used with supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion 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 vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. TI- L5) for partial replacement (i.e., partial vertebrectonv) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

The purpose of this 510(k) submission is to include additional PEEK spacer and titanium screw fixation configurations to the Lanx SA System. The new Lanx Lateral-SA system has the same intended use, principles of operation, and technological characteristics as the current Lanx SA svstem.

The Lanx Lateral-SA System devices are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6AI-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Lateral-SA System is provided non-sterile.

The Lanx Lateral-SA System is a medical device intended for spinal fusion procedures and vertebral body replacement. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes performance testing and engineering analysis to demonstrate substantial equivalence. It does not provide specific sample sizes (e.g., number of devices tested) for the ASTM tests mentioned (F2077, F2267, F1877). These tests typically involve a defined number of samples to ensure statistical validity, but the exact count is not disclosed in this summary.

The data provenance is laboratory-based engineering testing, rather than clinical data from human subjects. The report does not mention any country of origin for the data beyond being submitted to the FDA in the US, nor does it specify if the testing itself was retrospective or prospective in a clinical sense. It's prospective in the context of device development.

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

Not applicable. This submission relies on engineering and performance testing against established ASTM standards, not on expert interpretation of medical images or patient outcomes. Therefore, there's no "ground truth" in the sense of expert consensus on clinical findings.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. There was no clinical study involving human readers or interpretation requiring adjudication. Performance was evaluated against objective engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not describe an MRMC study or any study involving human readers with or without AI assistance. The submission focuses on the mechanical and material equivalence of the device to its predicate.

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

Not applicable. This is a physical medical device (spinal implant), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not relevant here.

7. The Type of Ground Truth Used:

The ground truth for the performance claim is based on established engineering standards (ASTM F2077, ASTM F2267, ASTM F1877) and a comparison to the mechanical properties of a predicate device (K102738). The "ground truth" is that the device must meet or exceed the performance of the predicate device under these standardized conditions.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable. As described above, there is no "training set" in the context of this device's evaluation.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Lanx Spinal Fixation System. The Lanx SA standalone interbody implants, when used with the integrated fixation screws, do not require use of supplemental fixation.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion 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 vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.

This submission is intended to seek clearance for a product line extension to the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System"). The product line extension includes the Lanx SA standalone implant models with titanium components for additional fixation.

All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and/or Titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The PEEK components include Tantalum markers per ASTM F560. The Fusion System has a hollowed out area to accommodate bone graft, and transverse grooves to improve fixation and stability. Additional fixation and stability is provided by screws which are made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

The additional models added to the product line have the same or similar intended use and indications, principles of operation and technological characteristics as the current Lanx Fusion System. The addition of titanium components for additional fixation, and indications for standalone lumbar interbody use, do not raise any new questions of safety or effectiveness. Mechanical testing and engineering analysis demonstrated comparable mechanical properties to the predicate devices.

Acceptance Criteria and Study for Lanx Fusion System

The Lanx Intervertebral Body/VBR Fusion System sought clearance for a product line extension, specifically for standalone implant models with titanium components. The study to prove the device meets acceptance criteria focused on demonstrating comparable mechanical properties to its predicate devices, thereby ensuring it did not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for each individual test (e.g., number of devices tested for static compression). However, it implies that the testing was conducted on "the Lanx Fusion System" as a representative sample of the product line extension.

The data provenance is not mentioned. It is common for such mechanical testing to be conducted in a laboratory setting, but the country of origin or whether it was retrospective/prospective is not specified.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Not applicable. This device clearance is based on mechanical performance data comparing the new device to predicate devices rather than clinical data requiring expert review of outcomes.

4. Adjudication Method (Test Set)

Not applicable, as the evaluation was based on objective mechanical testing results against established ASTM standards. No human adjudication of clinical outcomes or images was involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was conducted or mentioned, as the clearance was based on mechanical testing, not clinical performance with human readers.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a medical implant, not an AI algorithm. The performance discussed is the mechanical performance of the physical device.

7. Type of Ground Truth Used

The "ground truth" for this product line extension was established by the performance criteria defined in recognized ASTM standards (ASTM F2077 and ASTM F2267) for intervertebral body fusion devices. These standards provide objective metrics for mechanical performance parameters like compression, torsion, and subsidence.

8. Sample Size for Training Set

Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and existing knowledge of materials and biomechanics, rather than statistical training on a data set.

9. How Ground Truth for Training Set Was Established

Not applicable. (See #8 above). The design and development of the device would rely on established engineering principles, material science knowledge, and potentially prior device performance data, rather than a "ground truth" derived from a training set.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be level(s). combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system

All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136. The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

The Lanx Fusion System, a medical device for spinal fusion and vertebral body replacement, obtained 510(k) clearance (K083815) based on mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document refers to mechanical performance testing per ASTM F2077 and ASTM F2267. These are standard test methods for evaluating medical devices. The document does not specify the exact sample size (number of devices tested) for these mechanical tests, nor does it provide information about data provenance (e.g., country of origin, retrospective/prospective) for clinical or patient data, as this device's clearance was based on demonstrating substantial equivalence through engineering and mechanical testing, not new clinical data.

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

Not applicable. This device's clearance was based on mechanical testing and comparison to predicate devices, not on expert-adjudicated ground truth derived from clinical cases or images.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

• Engineering Standards: Compliance with established ASTM standards (F2077, F2267 for mechanical properties; F2026, F136 for materials).
• Predicate Device Performance: The mechanical characteristics of the new device were compared and found "comparable" to existing cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the sense of a data "training set."

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

Not applicable. See point 8.

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