Search Results

The Lanx Spinal Fixation System (SFS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The 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 (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, not intended for stand-alone use.

The purpose of this 510(k) submission is to modify the Surgical Technique for the Lanx Spinal Fixation System. No other changes have been made to the previously cleared system.

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 Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, ASTM F136 and 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 is a 510(k) summary for a medical device (Spinal Fixation System), not a study report for an AI/algorithm-driven device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm.

The request asks for details like:

• A table of acceptance criteria and reported device performance (for an AI/algorithm).
• Sample sizes, data provenance, expert ground truth establishment for a test set.
• Adjudication methods, MRMC studies, standalone performance, ground truth types.
• Training set details.

The provided document states: "Performance Data: No performance data was submitted to determine substantial equivalence." This means the submission is not based on new performance testing but rather on demonstrating substantial equivalence to a previously cleared predicate device due to a minor change (modification to the Surgical Technique).

Essentially, this device is a physical spinal implant, not an AI software/algorithm that would have "acceptance criteria" and "study results" in the way described in the prompt. The "performance data" if it were submitted for this type of device would typically relate to mechanical testing (e.g., fatigue, static strength) or biocompatibility, not clinical study outcomes or AI algorithm metrics.

Ask a specific question about this device

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 (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, 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 the addition of pedicle screw sizes to the SFS system.

The provided 510(k) summary for the Lanx Spinal Fixation System (K122145) describes a device modification, specifically the inclusion of additional pedicle screw sizes. As such, the submission primarily focuses on demonstrating substantial equivalence to the previously cleared predicate device rather than conducting a de novo study with acceptance criteria and a detailed comparative study for a novel device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not provide a table of explicit, quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device.

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

The document mentions "Engineering analysis" and "Engineering analyses" but does not specify:

• The sample size of any test set (e.g., number of pedicle screws or constructs tested).
• The data provenance (e.g., country of origin, retrospective or prospective nature).

These analyses would typically involve mechanical testing (e.g., fatigue, static strength) of various screw sizes and configurations.

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

This type of information is not applicable to this 510(k) submission. For a device modification like this, where the focus is on mechanical properties and substantial equivalence, "ground truth" established by experts in an clinical or imaging context is not relevant. The "ground truth" would be established by engineering standards and test methodologies.

4. Adjudication Method for the Test Set:

This is not applicable for the type of engineering analysis described. Adjudication methods (like 2+1, 3+1) are typically used for clinical or image-based studies where multiple readers assess outputs against a reference.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation devices, not for a spinal fixation system modification focused on mechanical properties. Thus, there is no mention of the effect size of human readers improving with or without AI assistance.

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

No, a standalone study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering standards and established mechanical test methodologies to evaluate the mechanical performance of the pedicle screws and the overall system. The comparison is made against the predicate device's known performance and relevant ASTM or ISO standards for spinal implants.

8. The Sample Size for the Training Set:

This concept is not applicable to this submission. The device is not an AI/machine learning model that requires a "training set." The engineering analyses performed are deterministic mechanical tests.

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

This is not applicable as there is no "training set" for this device.

Ask a specific question about this device

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 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); spondvlolisthesis: 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 purpose of this 510(k) submission is to add modified plates to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

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 Lanx Spinal Fixation System implants are fabricated from medical grade titanium alloy and/or cobalt chrome alloy per ASTM F67. 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.

The provided text is for a 510(k) premarket notification for a medical device, the Lanx Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and detailed performance studies typically associated with AI/ML devices or novel technologies.

Therefore, the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable or available within this document.

Here's why and what information is provided:

Explanation Regarding Missing Information:

This 510(k) submission for the Lanx Spinal Fixation System is for an orthopedic implant. For such devices, regulatory clearance is typically based on:

• Substantial Equivalence: Demonstrating that the new device has the same intended use, technological characteristics, and principles of operation as legally marketed predicate devices, and that any differences do not raise new issues of safety or effectiveness.
• Performance Testing (Benchtop): This usually involves mechanical and material testing to ensure the device meets engineering specifications and is comparable to predicates. It does not involve "performance" in the sense of predictive accuracy or diagnostic capability, which is relevant for AI/ML.

Information Extracted from the Document (and why other items are not applicable):

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance, as this relates to a mechanical device.
   • Reported Device Performance:
     • Performance Test: Static torsion tests using modified ASTM F 1717 methods.
     • Outcome: "The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate device."

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

   • N/A: The "test set" in this context refers to physical test specimens for mechanical testing, not a dataset for evaluating an algorithm. The document does not specify the number of physical components tested.

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

   • N/A: Not applicable for mechanical device testing.

4. Adjudication Method for the Test Set:

   • N/A: Not applicable for mechanical device testing.

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

   • N/A: This is not an AI/ML device, so MRMC studies are irrelevant.

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

   • N/A: This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • N/A: For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the materials and design.

8. The Sample Size for the Training Set:

   • N/A: This is not an AI/ML device, so there is no training set.

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

   • N/A: This is not an AI/ML device.

Additional Relevant Information from the Document:

• Device Type: Spinal Fixation System (orthopedic implant).
• Purpose of Submission: To add modified plates to an existing system.
• Materials: Medical grade titanium alloy and/or cobalt chrome alloy (ASTM F67, ASTM F136, ASTM F1537).
• Basis for Clearance: Substantial Equivalence to previously-cleared Lanx Spinal Fixation Systems (K043484, K071633, K071877, K090252, K083581, K092536, K093285, K100935, K103091, K103237, K120399, K120682).
• Conclusion: "The modified Lanx Spinal Fixation System has the same intended use, indications, technological characteristics, and principles of operation as the predicate system. The differences in the modified components do not raise any new issues of safety or effectiveness. Testing also demonstrated comparable properties to the previously cleared Lanx Spinal Fixation System. Thus, the modified Lanx Spinal Fixation System is substantially equivalent to the predicate device."

Ask a specific question about this device

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.

Ask a specific question about this device

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 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 (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, 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 Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, 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.

The provided text describes a 510(k) summary for the Lanx Spinal Fixation System, focusing on mechanical performance testing rather than performance in a clinical or diagnostic setting. Therefore, the questions related to clinical study design, human readers, ground truth establishment, and sample sizes for training sets are not applicable to the information contained in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to a comparison with a predicate device and adherence to ASTM standards. It does not explicitly state numerical acceptance criteria in a table format, but rather indicates that the modified device's performance was comparable to the predicate device and functioned as intended.

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

• Sample Size: Not explicitly stated in the document. The testing involved "the modified and predicate systems," implying an engineering test setup rather than a patient-based test set. The number of samples for each mechanical test (e.g., number of constructs tested) is not provided.
• Data Provenance: The data is generated from laboratory performance testing and engineering analysis of the physical device components. This is not patient-based data, so concepts like "country of origin" or "retrospective/prospective" do not apply.

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

This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717) and the physical properties of the materials and designs under controlled laboratory conditions, not by expert medical opinion.

4. Adjudication method for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when human expert consensus is required for ground truth. For mechanical testing, the "adjudication" is inherent in the adherence to established testing protocols and the direct measurement of physical properties.

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 document describes a mechanical spinal fixation system, not an AI-based diagnostic or treatment tool that would involve human readers or AI assistance.

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

This question is not applicable. This document describes a physical medical device (spinal fixation system), not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the performance testing is based on established engineering standards (ASTM F1717) for static and dynamic axial compression and static torsion, as well as additional expulsion, sheer, and compression tests. The performance of the modified device was compared directly to that of a predicate device under these standardized testing conditions.

8. The sample size for the training set:

This question is not applicable. The document describes a physical medical device undergoing mechanical performance tests, not a machine learning model that requires a training set.

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

This question is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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 (TI-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 (T I-S I). 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 purpose of this 510(k) submission is to add modified plates to the Lanx Spinal Fixation System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.

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 Lanx Spinal Fixation System implants are fabricated from medical grade titanium, titanium alloy and/or cobalt chrome alloy per ASTM F67, 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.

The provided documents describe the Lanx Spinal Fixation System, a medical device. The "study" described is a performance testing and engineering analysis rather than a clinical study. This type of testing is common for substantial equivalence submissions for implantable devices where functional equivalence to a predicate device is demonstrated through mechanical properties.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "Performance testing and engineering analysis," suggesting mechanical testing of a representative number of components or systems as per ASTM F1717. Specific numbers of constructs tested are not provided.
• Data Provenance: The testing was likely conducted in a lab environment (in vitro) and is prospective in nature for a device modification. The country of origin of the data is not specified, but the submitter is Lanx, Inc. in Broomfield, CO, USA.

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

• Not applicable. This study is a mechanical performance test comparing a modified device to a predicate device. There is no human interpretation or "ground truth" to be established by medical experts in this context. The "ground truth" here is adherence to engineering standards and demonstration of comparable mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. As this is a mechanical performance test, there's no human interpretation or adjudication in the medical sense. The "adjudication" is based on whether the test results meet the criteria for substantial equivalence when compared to the predicate device, as determined by engineering analysis.

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

• No. This document describes engineering performance testing on a medical device (spinal fixation system components), not a clinical or diagnostic imaging study that would involve human readers.

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

• Not applicable. This device is a physical spinal fixation system, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The device's performance is inherently "standalone" in its mechanical function.

7. The Type of Ground Truth Used

• Engineering Standards and Predicate Device Performance: The "ground truth" for the performance claims in this submission is the established performance of the legally marketed predicate device and compliance with recognized industry standards (e.g., ASTM F1717) for mechanical testing of spinal instrumentation. The goal was to prove "substantial equivalence" to the predicate.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI-based study; 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 AI algorithm, this question is not relevant to the provided document.

Ask a specific question about this device

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.

Ask a specific question about this device

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, 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 provided document is a 510(k) summary for the Lanx Spinal Fixation System, which is a medical device for spinal surgery. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does not contain any information about acceptance criteria, detailed study designs, sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device performance or clinical studies using human readers. The performance data section vaguely 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." This refers to mechanical and engineering testing, not a clinical study involving AI or human interpretation of data.

Therefore, I cannot provide the requested information from the given text. The device described is a physical surgical implant, not an AI or imaging diagnostic device that would typically have the kind of studies you're asking about.

Ask a specific question about this device

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 LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scollosis; 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 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 provided text describes the Lanx Spinal Fixation System, a medical device for spinal stabilization. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a diagnostic AI/ML device.

This document is a 510(k) summary for a physical medical implant (spinal fixation system), not a software or AI/ML diagnostic device. Therefore, the questions related to "acceptance criteria" and "performance studies" would be interpreted differently than for an AI/ML product. For a physical device like this, performance is typically demonstrated through engineering analyses and mechanical testing to ensure it meets pre-defined physical and mechanical properties and functions as intended, rather than through clinical studies with human readers or ground truth established by experts.

Given that context, here's an attempt to extract the closest relevant information based on the questions, acknowledging the significant mismatch in the type of device and study described:

1. Table of acceptance criteria and the reported device performance

For this physical device, "acceptance criteria" would typically refer to engineering specifications and mechanical performance benchmarks. The document states:

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

• Test Set Sample Size: Not applicable/not mentioned in the context of clinical data for a diagnostic device. The "test set" here would refer to components undergoing mechanical testing. The specific number of components or test specimens is not provided.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to mechanical test results.

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 a physical device is established through documented engineering standards, mechanical tests, and material science, not human expert consensus on clinical data.
• Qualifications of Experts: This would involve mechanical engineers, material scientists, and quality control personnel, but their specific roles or qualifications are not detailed in this summary.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert readings for diagnostic accuracy. For mechanical testing, results are typically determined by established test protocols and engineering analysis against acceptance limits.

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 a physical spinal fixation system, not a diagnostic AI device.

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

• Standalone Performance: Not applicable. There is no algorithm described.

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

• Type of Ground Truth: For a physical device, the "ground truth" for performance is defined by engineering specifications, validated mechanical test standards (e.g., fatigue, static strength), and material properties. The document implies compliance with these engineering standards to demonstrate substantial equivalence.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI/ML model or training set discussed.

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

• Ground Truth for Training Set: Not applicable. There is no AI/ML model or training set discussed.

Summary for an AI/ML context:

Based only on the provided text, there is no information about acceptance criteria or a study that typically applies to an AI/ML diagnostic device (e.g., sensitivity, specificity, clinical accuracy, reader studies). The document describes a traditional medical device (spinal fixation system) evaluated primarily through mechanical performance data and substantial equivalence to a predicate device.

Ask a specific question about this device

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.

Ask a specific question about this device