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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The System is intended for use with autograft or allograft.

The Lanx Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, 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; and failed previous fusion.

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). 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 (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The modifications contained herein consist of a modification to the threadform of the existing pedicle screws as well as a reduced size offset connector and accompanying set screw.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lanx Spinal Fixation System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes modifications to an existing device, the Lanx Spinal Fixation System, and states that these modifications do not raise new issues of safety or effectiveness. Therefore, the acceptance criteria are not explicitly numerical performance metrics in the way one might see for a diagnostic device. Instead, the acceptance criteria are based on demonstrating comparable mechanical properties and substantial equivalence to the predicate device.

Note: While specific numerical acceptance values for these mechanical tests are not provided in this summary, they would have been defined within the ASTM standards and the internal study protocols. The summary states the device "functioned as intended" and showed "comparable mechanical properties."

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

This is a mechanical testing study, not a clinical study involving patients or patient data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable here. The "sample size" would refer to the number of individual components tested within the mechanical studies. The document does not specify the exact number of components or samples used for the ASTM F1717 and ASTM F1798 testing.

The "data provenance" is derived from laboratory mechanical testing of the device components. There is no mention of country of origin for data as it's not clinical data, and it's not a retrospective or prospective clinical study.

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

Not applicable. This study involves mechanical testing against engineering standards, not expert-derived ground truth from medical images or clinical observations. The "ground truth" here is the specified performance criteria within the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in mechanical testing. The results are quantitative measurements against predefined engineering specifications.

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 a mechanical performance study of a spinal fixation system, not an AI-powered diagnostic device. Therefore, no MRMC study with human readers or AI assistance was performed.

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

Not applicable. This device is a physical medical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used

The ground truth used for this study is based on established engineering standards and specifications. Specifically, the device's mechanical performance was evaluated against the requirements outlined in:

• ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
• ASTM F1798: Standard Guide for Evaluating the Static and Fatigue Performance of Intervertebral Body Fusion Devices Under Combined Compression-Shear Loading.

The "ground truth" is that the device must meet or exceed the performance parameters defined by these standards and demonstrate comparability to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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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 intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:

• Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis .
• Spinal Stenosis .
• Trauma/Fracture/Dislocation .
• Atlanto-Axial Fracture with Instability .
• Occipito-Cervical Dislocation .
• Failed Previous Fusion .
• Tumor .
  The use of occipital bone screws is limited to placement in the occiput only.
  The use of polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The purpose of this Special 510(k) is to add a modified screw configuration in multiple sizes. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.
The Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F136 and ASTM F1537. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

This document describes the Lanx Posterior Cervicothoracic Spinal Fixation System, which is a spinal fixation system that provides supplemental stabilization of spinal segments to support fusion. This submission is a Special 510(k) to add a modified screw configuration in multiple sizes. The device is substantially equivalent to a predicate device and is intended for use in the occipito-cervico-thoracic region of the spine in skeletally mature patients for various conditions.

Here's the information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device." This implies that the acceptance criteria for the modified device were to perform comparably to the previously-cleared predicate device in the specified mechanical tests. The specific quantitative thresholds for "substantial equivalence" or "functioned as intended" are not provided in this summary.

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

• Sample Size: Not explicitly stated. The document mentions "Performance testing was conducted to characterize the modified components of the system. Tests were performed on the modified and predicate systems..." This implies a comparative test, but the number of units tested is not specified.
• Data Provenance: Not applicable in the context of device performance testing. The tests are experimental/laboratory-based, not based on patient data.

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

Not applicable. This is mechanical performance testing of a physical device, not an AI/software device that requires expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical performance testing of a physical device.

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

No. This document describes the mechanical performance testing of a spinal fixation system, not a study involving human readers or AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This document is about a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" is established by the standardized test methods outlined in ASTM F1717 and ASTM F1798. The performance of the predicate device serves as the benchmark against which the modified device's performance is compared to establish substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

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

Not applicable. This is a physical medical device, not a machine learning model.

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Lanx SFS is 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 or deformities of the thoracic, lumbar and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinous Process Fusion Plate (SPFP) is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-SI). 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 (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material, not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, hooks, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

This submission pertains to the Lanx Spinal Fixation System. The provided document is a 510(k) summary and associated FDA correspondence, which primarily focuses on establishing substantial equivalence for a medical device.

Based on the provided text, there is no acceptance criteria or study that proves a device meets specific acceptance criteria in the context of an AI/ML device. This document is for a traditional spinal fixation system, not an AI-powered diagnostic or therapeutic device.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document discusses the performance of a traditional medical device (spinal fixation system) based on engineering analysis and mechanical testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the "Performance Data" section in the context of this traditional device:

The document states:
"Performance testing and engineering analysis was performed and submitted to characterize the modified components of the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

Summary of Device Performance and Substantial Equivalence:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics in the provided text. The implicitly accepted criterion is that the device, after modifications, "functioned as intended" and demonstrated "comparable mechanical properties" to the predicate device. The ultimate acceptance criterion from an FDA perspective is showing "Substantial Equivalence" to a legally marketed predicate.
• Study Proving Acceptance: "Performance testing and engineering analysis" was performed.
• Specifics of the study (as much as can be inferred from the text):
  • Nature of Study: Mechanical testing and engineering analysis.
  • Purpose: To characterize modified components and demonstrate that the device functioned as intended, and to show comparable mechanical properties to the previously cleared Lanx Spinal Fixation System (the predicate).
  • Outcome: The testing and analysis "demonstrated comparable mechanical properties" leading to the conclusion of "substantial equivalence."

Key points from the document regarding substantial equivalence that replace the requested AI/ML specific information:

• Predicate Device: Lanx Spinal Fixation System (implicitly the pre-modified version).
• Basis for Substantial Equivalence:
  • Same intended use.
  • Same indications for use.
  • Same technological characteristics.
  • Same principles of operation as the predicate device.
  • Modifications do not raise new issues of safety or effectiveness.
  • Testing and engineering analysis demonstrated comparable mechanical properties.

In conclusion, the provided text describes a 510(k) submission for a non-AI spinal fixation system. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence through mechanical testing and engineering analysis, rather than the performance metrics typically associated with AI/ML device evaluation.

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When used as a cervical intervertebral body fusion device, the Lanx Small Intervertebral Body/VBR 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 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 Small Intervertebral Body/VBR 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. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

When used as vertebral body replacement, the Lanx Small Intervertebral Body/VBR 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 vertebrectory) of a diseased vertebral body resected or excised for the treatment of turnors 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 Small Intervertebral Body/VBR Fusion system is made of PEEK-OPTIMA® or titanium alloy. 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 Small Intervertebral Body/VBR Fusion System is provided non-sterile.

The provided text describes a medical device, the Lanx Small Intervertebral Body/VBR Fusion Device, and its 510(k) summary for FDA clearance. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance data.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide information regarding:

• The specific sample sizes used for the testing.
• The data provenance (e.g., country of origin of the data, retrospective or prospective) for the performance tests.

The performance data refers to "Performance testing was conducted per ASTM F2077-03 and ASTM F2267-04," which are standard testing methods for intervertebral body fusion devices. These standards typically define the methodologies for mechanical testing (e.g., static and dynamic axial compression, torsion), but the exact number of samples tested by the manufacturer to meet these standards is not specified in this document.

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

This information is not applicable to the type of performance data presented. The performance testing described is mechanical, conducted according to ASTM standards, and does not involve human expert evaluation for establishing "ground truth" in the way a clinical study or diagnostic AI would.

4. Adjudication Method for the Test Set:

This information is not applicable as the performance data relates to mechanical testing against engineering standards, not human evaluation or ground truth establishment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned. This document describes the clearance of a physical medical device, not an AI software or diagnostic tool that would typically undergo such a study.

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

This is not applicable. The device is a physical intervertebral body fusion device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the specified mechanical performance requirements and limits outlined in ASTM F2077-03 and ASTM F2267-04. The device's ability to withstand certain forces, displacements, and cycles without failure (as defined by these standards) serves as the ground truth for its mechanical performance.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."

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

This information is not applicable for the reasons stated above.

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The Lanx Intervertebral Body Fusion Device ("Lanx Fusion System") is indicated for use 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. Approved supplemental fixation systems include the Lanx Spinal Fixation System,

The Lanx Fusion System is made of PEEK-OPTIMA® 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 accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

Here's an analysis of the provided text regarding the Lanx, LLC's Intervertebral Body Fusion Device, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance for Lanx Intervertebral Body Fusion Device (K073144)

Based on the provided 510(k) summary, the device is a mechanical implant, and its performance evaluation relies on engineering standards rather than clinical study endpoints that would involve human physiological measures.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Standards:

• ASTM F2077-03: Standard Test Methods for Intervertebral Body Fusion Devices - This standard covers static and fatigue compression, compression-shear, and torsion testing methods for intervertebral body fusion devices. It establishes a repeatable method for the mechanical evaluation of these implants.
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression - This standard describes a method for measuring the subsidence (or sinking) of an intervertebral body fusion device into vertebral bone under static axial compression. It helps assess the short-term stability and potential for implant migration.

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

• The document does not specify the exact sample sizes (number of devices tested) for the ASTM F2077-03 and ASTM F2267-04 tests. These standards typically define minimum sample sizes for reliable testing, but the specific number used by Lanx, LLC is not disclosed in this summary.
• Data Provenance: The data is from engineering performance testing, not human clinical data. Therefore, there is no country of origin or retrospective/prospective classification in the context of clinical studies. The testing was conducted by Lanx, LLC or a contracted lab under their purview.

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

• This question is not applicable to this device. As discussed, the device underwent mechanical engineering testing to established ASTM standards. Ground truth for these tests is defined by the physical properties and performance characteristics dictated by the standards themselves, not by expert medical interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable to this device. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical trials or image interpretation studies where expert consensus is needed to establish a "ground truth" for diagnostic accuracy. For engineering tests, the "ground truth" is defined by the measurement protocols and pass/fail criteria of the specified ASTM standards.

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. This type of study is relevant for evaluating the diagnostic performance of software, particularly in imaging, to see how it affects human reader performance. The Lanx Intervertebral Body Fusion Device is a physical implant, not a diagnostic or AI-powered imaging device.

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

• This question is not applicable to this device. A standalone performance study refers to the performance of an AI algorithm without human intervention, typically in diagnostic tasks. The Lanx device is a physical implant, so this concept does not apply.

7. The Type of Ground Truth Used

• The "ground truth" for the performance data in this instance is compliance with pre-defined mechanical engineering standards (ASTM F2077-03 and ASTM F2267-04). These standards define the expected mechanical behavior (e.g., strength, stiffness, fatigue resistance, subsidence) of intervertebral body fusion devices. The device met these objective, measurable criteria.

8. The Sample Size for the Training Set

• This question is not applicable to this device. "Training set" refers to data used to train machine learning models. The Lanx Intervertebral Body Fusion Device is a physical implant, not an AI or machine learning product. Its design and performance are based on engineering principles and materials science, not statistical learning from a training dataset in the AI sense.

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

• This question is not applicable to this device for the reasons stated in point 8.

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When intended to promote fusion of the cervical spine and the thoracic spine (C1-T3) in skeletally mature patients, the LANX Posterior Cervicothoracic Spinal Fixation System (PCFS) is indicated for the following:

• · Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• · Spondylolisthesis
• · Spinal Stenosis
• · Fracture/Dislocation
• · Failed previous fusion
• · Tumor

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine,

The Lanx Posterior Cervicothoracic Spinal Fixation System consists of various titanium alloy screws, rods, hooks, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient.

The provided text describes a 510(k) premarket notification for the LANX Posterior Cervicothoracic Spinal Fixation System. This is a spinal fixation device, which typically undergoes mechanical performance testing rather than studies involving human readers or AI algorithms for diagnostic purposes. As such, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: Not specified for the mechanical tests. Mechanical testing typically involves a set number of device components or constructs rather than patient data.
• Data Provenance: Not applicable in the context of mechanical performance testing. This is not a study involving patient data.

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. Ground truth for mechanical testing is established by adherence to specified test methods and measurable physical properties, not expert consensus.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. Mechanical testing results are objective measurements against established standards, not subject to adjudication in the human-reader sense.

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:

• No MRMC comparative effectiveness study was done. This device is a physical spinal implant, not a diagnostic AI device that would involve human readers.

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

• No standalone algorithm performance study was done. This device is not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is objective mechanical properties and structural integrity as measured against established ASTM standards (F1717 and F1798), and comparison to the mechanical properties of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device.

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

• Not applicable. This is not a machine learning device.

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The Lanx Spinal Fixation System (SFS) is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.

The Lanx SFS is 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 or deformities of the thoracic, lumbar and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinous Process Fusion Plate (SPFP) 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 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 (i.e., fracture or dislocation); and/or tumor. The Lanx SPFP is intended for use with bone graft material and is not intended for stand-alone use.

The Lanx Spinal Fixation System consists of various screws, rods, plates, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, allowing the surgeon to tailor the construct to the particular needs of the patient. The purpose of this 510(k) is to add the Spinous Process Fusion Plate to the Lanx SFS.

The provided document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with many of the requested parameters.

This document is a 510(k) summary for a medical device (Lanx Spinal Fixation System), which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Here's a breakdown of what can and cannot be extracted from the document:

What can be extracted:

• Device Name: Lanx Spinal Fixation System
• Intended Use/Indications for Use: Clearly stated in the document.
• Technological Characteristics: Describes the components and their purpose.
• Performance Data (General Statement): "Performance testing was performed and submitted to characterize the new components being added to the system. The Lanx Spinal Fixation System functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices."

What CANNOT be extracted from this document:

• Specific Acceptance Criteria: The document states that performance testing was done, but it does not specify what those criteria were (e.g., specific thresholds for fatigue life, pull-out strength, etc.).
• Reported Device Performance (Quantitative): While it states the device "functioned as intended" and demonstrated "substantial equivalence," it doesn't provide actual numerical results from the performance tests.
• Sample size used for the test set: Not mentioned.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts used to establish ground truth & qualifications: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable. This is a spinal fixation system, not an AI/imaging device intended to assist human readers.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used: Not applicable, as this refers to clinical outcomes or expert labels, which are not detailed for mechanical testing.
• Sample size for the training set: Not applicable (no AI/machine learning model).
• How ground truth for the training set was established: Not applicable.

Summary Table of Unavailable Information:

Explanation:

The document describes a Spinal Fixation System, which is a physical implant, not a software algorithm or AI device. Therefore, many of the requested points related to AI performance, ground truth establishment by experts, and reader studies are not relevant or present in this type of 510(k) submission.

For mechanical devices like this, "performance data" typically refers to biomechanical testing (e.g., fatigue strength, static bending strength, pull-out strength, torsional strength). The 510(k) summary only states that such testing was performed and demonstrated substantial equivalence to predicate devices, without detailing the specific tests, methodologies, acceptance criteria, or quantitative results. This level of detail is often found in the full 510(k) submission and not typically in the publicly available summary.

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The Lanx Spinal Fixation System is 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 or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Lanx Spinal Fixation System is a posterior attachment pedicle fixation system. The system consists of a series of polyaxial screws, rods, cross connectors and interlocking mechanisms. The components are manufactured from alloyed titanium. This submission is intended to address a line extension to the Lanx Spinal Fixation System. The line extension includes additional pedicle screw sizes/configurations, hooks, connectors and the introduction of unalloyed titanium rods.

This document, K071633, is a 510(k) summary for a medical device (Lanx Deformity System - a spinal fixation system) and does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices.

Instead, this 510(k) submission is for a line extension of an existing spinal fixation system. For such devices, acceptance criteria and "studies" usually refer to mechanical testing to demonstrate performance and equivalence to a predicate device for regulatory approval, rather than clinical studies with human participants or AI/ML model performance metrics.

Here's a breakdown based on the provided text, and where your requested information would typically not apply to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Implied): Mechanical properties comparable to the predicate device.
• Reported Device Performance: "Mechanical testing also demonstrated comparable mechanical properties to the predicate device."

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

• Not Applicable. This is a hardware submission, not based on a "test set" of patient data for AI/ML. The "test set" would be the physical samples of the device undergoing mechanical testing. The specific number of samples tested is not mentioned in this summary but would be detailed in the full test report. Data provenance (country of origin, retrospective/prospective) is irrelevant in this context.

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

• Not Applicable. Ground truth in this context would be engineering specifications and standards for mechanical testing, verified by qualified engineers, not medical experts.

4. Adjudication method for the test set:

• Not Applicable. Mechanical testing results are compared against established engineering standards or predicate device performance, not adjudicated by multiple reviewers in a clinical sense.

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 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 device.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" would be established engineering standards, material specifications, and performance data from the predicate device.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. There is no "training set."

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

• Not Applicable.

Summary of the Study (as described in the 510(k) summary):

The "study" refers to mechanical testing that was conducted on the Lanx Deformity System to demonstrate that its components (new pedicle screw sizes/configurations, hooks, connectors, and unalloyed titanium rods) have "comparable mechanical properties" to the predicate device (Lanx Spinal Fixation System, K043484). The core argument for substantial equivalence is that "The minor differences in the line item extensions items do not raise any new questions of safety or effectiveness" and are supported by this mechanical testing.

In essence, the "acceptance criterion" for this submission was demonstrating that the new elements of the system perform mechanically at a level equivalent to the already approved predicate device, thereby ensuring safety and effectiveness.

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The Lanx VBR 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 TI to LS) The Lanx VBR System may also be used in the thoracolumbar spine (i.e., Ti- 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 VBR System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx VBR 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.

Implants: The Lanx VBR implants consists of a series of flat, trapezoidal, rectangular and curved shaped The device is offered in different size/configurations to better approximate the anatomical implants. variation observed in different vertebral levels and/or patient anatomy. The devices are manufactured with a hollowed out central area to accommodate bone graft material. The upper and lower surfaces are manufactured in such a way that a series of transverse slots or grooves are formed to improve stability and fixation once the device is inserted.

Materials: all implants are made from implant grade PEEK with titanium position markers, Instruments: The instruments are made from instrument grade stainlens steel.

The provided 510(k) summary describes a spinal intervertebral body fixation orthosis (Lanx VBR) and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/Software as a Medical Device (SaMD) submission.

This document is a 510(k) Premarket Notification for a physical medical device (a spinal implant made of PEEK with titanium markers), not a software device or AI algorithm. Therefore, the questions related to AI/MRMC studies, ground truth, training sets, and sample sizes for test sets in the context of AI/SaMD are not applicable to the information provided.

The "Testing Summary" section is the only part that mentions device performance.

Here's an analysis based on the provided text, highlighting the absence of information relevant to AI/SaMD acceptance criteria and studies:

Acceptance Criteria and Device Performance (as described for this physical device)

Regarding the specific questions which are geared towards AI/SaMD:

1. A table of acceptance criteria and the reported device performance: See table above. It describes general testing results for a physical device, not typically quantitative metrics for AI.

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. This information is for AI/SaMD. The document refers to "samples" for fatigue and static testing, which would be physical implant units, not data sets. No specific sample size for these physical tests is provided, nor is data provenance relevant.

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 information is for AI/SaMD. Ground truth in this context would typically refer to clinical diagnoses or annotations for an AI algorithm. For a physical implant, "ground truth" might refer to engineering standards or clinical outcomes observed during physical testing, but no specific expert involvement for this is detailed.

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

   • Not applicable. This information is for AI/SaMD.

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 a physical implant, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This is a physical implant, not an AI algorithm.

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

   • For the physical device, the "ground truth" for the fatigue and static testing would be accepted engineering and scientific principles and comparison to predicate device performance. For biocompatibility, it would be data from a device material Master File (MAF) recorded with the FDA. No clinical ground truth (expert consensus, pathology, outcomes data) as understood in an AI/SaMD context is mentioned.

8. The sample size for the training set:

   • Not applicable. This is for AI/SaMD.

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

   • Not applicable. This is for AI/SaMD.

Conclusion:

The provided 510(k) summary is for a traditional, physical medical device (spinal implant). It establishes substantial equivalence based on design, material composition, surgical technique, intended use, and fatigue/static testing outcomes that are equivalent to comparison devices. It also references a Material Master File for biocompatibility.

The document does not contain any information pertaining to the development or validation of an Artificial Intelligence (AI) or Software as a Medical Device (SaMD) product. Therefore, the specific questions regarding AI/SaMD acceptance criteria, test/training sets, ground truth establishment, expert adjudication, or MRMC studies cannot be answered from this text.

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