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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stcnosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pscudarthrosis: and/or failed previous fusion.

Except for hooks, when used as an anterolatcral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pediale screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks. rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add 6.35mm implants to the system.

This FDA submission describes a spinal fixation system, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (like accuracy, sensitivity, specificity, and MRMC studies) are not applicable.

The submission focuses on establishing substantial equivalence to previously marketed devices based on design features and material properties. The primary way this device meets its "acceptance criteria" is by demonstrating it is as safe and effective as existing, legally marketed spinal systems.

Here's an analysis based on the provided document, addressing the original prompt's categories where applicable for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. For mechanical testing, the "worst case components" were selected for testing, implying a representative sample of components or configurations were tested to cover the range of mechanical properties. The specific number of components or implants tested is not provided in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance. The mechanical test data would be generated in a laboratory setting (likely within the company or a certified testing facility).

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

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic tool requiring expert interpretation of outputs to establish ground truth. Substantial equivalence for this device is based on technical comparisons and mechanical testing against recognized standards.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication" in the sense of reconciling clinical interpretations for this type of device. The determination of "worst case" for mechanical testing would be an engineering assessment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a spinal implant.

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

• No, a standalone algorithm performance evaluation was not done. This device is a physical medical implant, not a software algorithm.

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

• For mechanical testing, the "ground truth" is defined by established engineering standards (ASTM F1717) and successful performance within those standards, demonstrating adequate strength and durability.
• For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use an AI/ML "training set."

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

• Not applicable. As there is no AI/ML component, there is no "training set" or ground truth for it.

Summary regarding the device's "acceptance":

The Range Spinal System gained FDA clearance (K141147) by demonstrating substantial equivalence to predicate devices already on the market. This means the FDA concluded that the new device is as safe and effective as the existing devices. The key elements for this determination were:

• Design and Material Comparison: The new components (6.35mm implants) were found to be "substantially the same" in design features and materials (Titanium Alloy and Cobalt Chrome per ASTM/ISO standards) as predicate devices.
• Mechanical Performance: The "worst case components" of the system were previously tested against established standards (ASTM F1717) for static compression bending, static torsion, and dynamic compression. The proposed new implants were determined by engineering analysis not to represent a "new worst case," implying they perform comparably or better than previously tested components and meet the required mechanical integrity.
• Intended Use: The indications for use are consistent with those of the predicate devices.

Essentially, the "study" for this device was a combination of engineering analysis and mechanical testing against industry standards, alongside a direct comparison of its technical characteristics and intended use to already cleared predicate devices.

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RANGE /DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis: curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Range Spinal System may also be used for the same indications as an adjunct to fusion. Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA and DENALI®) Spinal Systems, all of which are cleared for the following indications: Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation): spinal stenosis: curvatures (i.e.. scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion. Except for hooks. when used as an anterolaicral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion. When used for posterior non-cervical pedicle screw fixation in pcdiatric patients the Everest Spinal System implants arc indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices arc to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range and Everest Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consist of pedicle screws, rods, locking set screws, hooks, rod connectors and transverse connectors.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

This submission is for a spinal fixation system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, and training set information is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, intended use, and mechanical performance testing (static compression, static torsion, and dynamic compression in accordance with ASTM F1717). The "acceptance criteria" here refer to the device's ability to meet these established ASTM standards and demonstrate equivalence to previously cleared devices.

Summary of Relevant Information from the Provided Text:

• Device: Range Spinal System, Everest Spinal System (spinal fixation systems)
• Purpose of Submission: To expand the indications for use for these systems.
• Performance Data: The Range and Everest Spinal System components were previously tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717.
• Conclusion: The devices were determined to be substantially equivalent to predicate devices based on these tests and a review of literature concluding expanded indications do not result in new safety/effectiveness issues.
• Regulatory Class: Class III

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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System.is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to incorporate additional screws and rods into the system.

The provided text is a 510(k) summary for the K2M Range Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study where a device's performance is measured against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document.

The document states:

• Acceptance Criteria/Reported Device Performance: Not explicitly defined or reported in terms of specific performance metrics. The claim is based on substantial equivalence to predicate devices.
• Study Proving Acceptance Criteria: The study proving substantial equivalence is an "Engineering rationales were used to compare the modified implants to predicate devices that were previously tested in static compression, static torsion and dynamic compression in accordance with ASTM F 1717." This is a mechanical engineering comparison, not a clinical study involving human or animal data.
• Sample Size for Test Set and Data Provenance: Not applicable as it's an engineering comparison to predicate devices, not a test set for an algorithm or a clinical trial.
• Number of Experts and Qualifications: Not applicable as no ground truth was established by experts for a test set.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No MRMC study was performed or mentioned.
• Standalone Performance Study: No standalone clinical performance study was done; the evaluation relied on substantial equivalence through engineering rationales.
• Type of Ground Truth Used: The ground truth used is the ASTM F 1717 standard for mechanical testing, which served as the benchmark for comparing the modified implants to the predicate devices.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, this 510(k) submission successfully demonstrated substantial equivalence based on engineering comparisons and previous testing of predicate devices against established ASTM standards, rather than presenting a performance study against novel acceptance criteria with clinical data.

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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degencration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.c. fracture or dislocation); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System.is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pediale screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, connectors, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add titanium bilateral contoured unit rods to the system.

The provided text describes a 510(k) summary for the Range Spinal System, a medical device for spinal fixation. It aims to demonstrate substantial equivalence to predicate devices, focusing on the addition of titanium bilateral contoured unit rods.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a "test set" in the context of clinical data. The performance comparison refers to mechanical testing of implants. There's no mention of human subject data, and therefore no provenance information (e.g., country of origin, retrospective/prospective).

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

This information is not applicable as the summary focuses on mechanical and design equivalence, not clinical performance requiring expert ground truth or assessment of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. This submission is for a spinal fixation system, a physical implant, not an AI-assisted diagnostic device.

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

This information is not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" for this device appears to be:

• Predicate Device Performance: The established performance and safety of the previously cleared K2M Range Spinal System and Synthes USS, Click'X, VAS. Dual -Opening, Small Stature (K022949).
• ASTM F1717 Standards: These provide the engineering standards for testing spinal fixation devices, against which the modified implants were evaluated.
• Engineering Rationale: An engineering assessment determining that the changes do not introduce a "new worst case."

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical device testing or clinical data for an implant.

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

This information is not applicable for the same reasons as point 8.

Study That Proves the Device Meets the Acceptance Criteria:

The study that proves the device meets the acceptance criteria is an engineering and mechanical testing comparison study.

• Methodology: The "modified implants were compared to constructs previously tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717."
• Conclusion: Based on this comparison, an "engineering rationale determined that the proposed implants do not represent a new worst case" and were "therefore determined to be substantially equivalent to the predicate devices."

In essence, the study was a benchtop mechanical performance evaluation demonstrating that the updated components of the Range Spinal System (specifically the bilateral contoured unit rods) meet the established mechanical performance standards and do not introduce new risks compared to the previously cleared predicate devices. The acceptance criteria were met by showing equivalence in mechanical properties to previously cleared devices under standardized test conditions.

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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients recciving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add Small Stature connectors and transition Rail/Rods to the system.

The provided document is a 510(k) summary for the K2M Range Spinal System, specifically for "Small Stature, Additional Components." This document is a premarket notification to the FDA for a medical device and does not describe a study involving patient data or AI. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through design and performance characteristic comparisons.

Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of submission.

Here's an attempt to answer based on the information available and the nature of a 510(k) submission for spinal systems:

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

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

This submission does not involve a "test set" in the context of patient data or algorithm performance. The "testing" referred to is mechanical testing of physical implants. The document does not specify the number of implants tested or the provenance of any data beyond mechanical testing according to ASTM standards. It's a regulatory submission affirming mechanical equivalence.

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. There is no "ground truth" derived from expert review of patient data in this submission. The "ground truth" for substantial equivalence is based on engineering and regulatory review of device specifications and mechanical test results against established predicate devices.

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

Not applicable. There is no expert adjudication of a test set in this context.

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 medical device submission for a spinal implant system, not an AI-based diagnostic or assistive technology.

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

Not applicable. This device is a physical spinal implant system, not a software algorithm.

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

Not applicable. The "ground truth" for this 510(k) submission is the pre-established safety and effectiveness of the identified predicate devices, as demonstrated through their prior FDA clearance and mechanical testing standards (ASTM and ISO). Substantial equivalence is established by showing the new device shares fundamental technological characteristics and performance (mechanically) without raising new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. There is no training set involved as this is a physical medical device, not an AI model.

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

Not applicable. There is no training set for an AI model.

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RANGE /DENALI/MESA, SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skelcially mature patients reveiving fusion by autogenous bone graft having implants attached to the lumbar and sucral spine ( L3 10 sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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.c. fracture or dislocation); spinal stenosis; curvatures ( i.c. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical lixation in pediatric patients. The Runge Spinal System for pediatric use is intended to be used with autografi. Pediatric pediale screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add modified rods and hooks and to incorporate previously cleared implants that were not included in the pediatric submission.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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: The document refers to "Constructs representing the worst case components." It does not specify a numerical sample size but implies a selection of representative configurations rather than a large statistical sample of individual implants.
• Data Provenance: The study was a comparison to previously tested predicate devices. The document does not explicitly state the country of origin or whether the data for the Range Spinal System was retrospective or prospective, but it's implied to be data generated to support the 510(k) submission.

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

• This document describes a mechanical performance study, not a clinical study involving ground truth established by medical experts for a test set. Therefore, this section is not applicable to this submission. The "ground truth" here is the performance according to ASTM standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

• This document describes a mechanical performance study, not a clinical study requiring adjudication of expert interpretations. Therefore, this section is not applicable to this submission. The results were likely validated by engineers and testing personnel.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a submission for a spinal fixation system, and the studies described are mechanical performance tests comparing the device to predicates, not clinical studies evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop performance)

• This question is not applicable. The device is a physical spinal implant system, not an algorithm or AI software. The performance studies conducted were mechanical strength and durability.

7. Type of Ground Truth Used

• The "ground truth" for this submission is based on engineering standards (ASTM F1717) and direct comparative mechanical testing against predicate devices. The performance of the Range Spinal System was measured against established benchmarks for spinal fixation devices.

8. Sample Size for the Training Set

• This question is not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device is the engineering design and manufacturing process to meet specified standards.

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

• This question is not applicable. As stated above, this is not an AI/machine learning device.

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RANGE /DENALI, MESA and SMALL STATURE and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scollosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skelctally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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: curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices.are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this submission is to add modified Small Stature components (screws, hooks and connectors) to the system.

The provided text describes a 510(k) submission for the Range Spinal System, focusing on adding modified Small Stature components. This is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of an AI algorithm or diagnostic device. Therefore, much of the requested information (e.g., acceptance criteria for a diagnostic device, sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth details) is not applicable to this document.

However, I can extract the relevant information regarding the device's acceptance criteria (in terms of performance) and the study that demonstrates it meets these criteria based on the provided text.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text refers to "modified implants" and "predicate devices" but does not quantify the number of implants or tests performed.
• Data Provenance: Not explicitly stated, but the testing was conducted in accordance with ASTM standards, suggesting a controlled testing environment rather than patient data. It is neither retrospective nor prospective in the context of a human study.

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

• This information is not applicable. This document describes physical testing of spinal implants, not a diagnostic device requiring expert interpretation for ground truth.

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

• This information is not applicable as it pertains to expert review of diagnostic data, which is not relevant here.

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 information is not applicable. This is not an AI-assisted diagnostic device, and no human reader studies are mentioned.

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

• This information is not applicable. This document describes physical device testing, not an algorithm.

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

• The "ground truth" in this context is the performance of the predicate devices as established through prior testing (static and dynamic compression, static torsion per ASTM). The modified implants' performance in these same physical tests serves as the comparison to demonstrate substantial equivalence.

8. The sample size for the training set

• This information is not applicable. There is no training set as this is not a machine learning or AI device.

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

• This information is not applicable. There is no training set. The "ground truth" for the comparison was established by the previously validated performance of the predicate devices.

Summary of the Study:

The study proving the device meets its acceptance criteria is a mechanical performance study. The "modified implants" of the Range Spinal System were subjected to physical tests:

• Static compression
• Static torsion
• Dynamic compression

These tests were performed in accordance with ASTM standards. The results of these tests were then compared directly to the performance of predicate devices that had undergone the same battery of tests previously. The conclusion was that the modified implants were "substantially equivalent" to the predicate devices in these mechanical performance aspects, as well as in design, function, material, and intended use. This substantial equivalence determination allowed the device to proceed to market.

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RANGE/ DENALI/ MESA and ARI are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion, in skeletally mature patients, for the following indications: 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; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Except for the ARI staples, the Range Spinal System .is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the Range Spinal System:

The provided text does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the way one would typically expect for a software or AI-driven medical device submission. This 510(k) is for a spinal implant system (mechanical device), and its evaluation relies on different methodologies.

Therefore, many of the requested fields cannot be answered from the provided text. I will fill in what can be inferred or explicitly stated, and note when information is absent.

Acceptance Criteria and Device Performance for the Range Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of this submission. The "test set" here refers to mechanical testing. The submission does not specify the number of implants tested in the mechanical studies.
• Data Provenance: The mechanical tests were performed by K2M, Inc. to ASTM F1717 standards. The "clinical results" are from "similar devices" (predicates), implying published literature, but no specific provenance (country, retrospective/prospective) for these clinical results is provided for the original predicates' studies.

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

• Not applicable. This device is a mechanical implant. Ground truth as typically defined for AI/software devices (e.g., expert radiological reads, pathology) is not relevant here. The "truth" for this submission is established through engineering principles and compliance with mechanical testing standards.

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

• Not applicable. This is not a study requiring adjudication of interpretations of clinical data.

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. This is a spinal implant, not an AI software device.

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

• No. This is a spinal implant, not an AI software device.

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

• For the mechanical performance, the "ground truth" is defined by the specifications and acceptable failure modes within the ASTM F1717 standard and the comparative performance to predicate devices.
• For the clinical aspects, the submission relies on the historical clinical safety and efficacy of the predicate devices, which would have been established through their own clinical trials or post-market surveillance. No new clinical ground truth was established for this specific 510(k).

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that uses a "training set."

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

• Not applicable. This is not an AI/software device that uses a "training set."

Summary of the Study per the 510(k):

The "study" or rather, the evaluation presented for the Range Spinal System in K121630, is primarily a comparative engineering and material performance assessment against predicate mechanical devices.

• Mechanical Testing: The Range Spinal System implants underwent static compression, static torsion, and dynamic compression testing in accordance with ASTM F1717. The results of these tests indicated that the implants were substantially equivalent to the predicate devices.
• Design and Material Comparison: The design features, sizing, and materials (Titanium Alloy and Cobalt Chrome per ASTM and ISO standards) were compared to predicates and found to be substantially the same.
• Clinical Efficacy (Indirect): The submission explicitly states that "Published clinical results for similar devices supported the safety and efficacy of these devices." This indicates reliance on the established clinical history of the predicate devices rather than new clinical data generated for the Range Spinal System itself.

Conclusion of the 510(k):

The submission concludes that there are "no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product." It is deemed substantially equivalent in design, function, material, and intended use to its predicates. The purpose of this specific submission was to expand the indications for use to include adolescent idiopathic scoliosis, based on this substantial equivalence argument.

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The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: 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; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors. The purpose of this submission is to add larger Mesa screws, transition rods, hooks, transverse connectors and rod connectors to the system.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the posterior thoracic and lumbar spine.

The provide 510(k) summary does not contain information typically associated with the acceptance criteria and study design for AI/ML devices, such as performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training data, expert qualifications, or details about standalone or MRMC studies.

Instead, this document describes a traditional medical device (Range Spinal System - spinal fixation system components) and its submission for 510(k) clearance based on substantial equivalence to predicate devices. The "performance data" referred to in the document relates to mechanical testing of the components, not clinical performance or AI/ML algorithm performance.

Therefore, I cannot fulfill the request as the provided text does not contain the required information for an AI/ML device.

However, I can extract the information that is present regarding the device's technical performance relative to acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a mechanical testing study comparing the modified components of the Range Spinal System to its predicate devices and original components.

Information on requested AI/ML specific aspects (Not applicable to this device type based on the provided text):

• Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical device components for mechanical testing. No patient data is mentioned for performance evaluation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on standardized tests and measurements, not expert consensus on clinical data.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For mechanical properties, the "ground truth" is derived from the physical properties of the materials and the results of the standardized ASTM F1717 tests.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The Range Spinal System is comprised of the DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( LS to sacrum) with removal of the implants after the attainment of a solid fusion.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: 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; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Range Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The K120899 submission is for the Range Spinal System, specifically to add a "unit rod" component. This is a spinal fixation system, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested categories for AI/ML device studies, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for training sets, are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices through design comparisons and mechanical performance testing.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices and adherence to ASTM standards for mechanical testing. The reported performance demonstrates substantial equivalence to these established benchmarks.

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

Not applicable. This is a physical device, and the "test set" refers to physical implants undergoing mechanical stress testing, not a dataset of patient information or images.

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

Not applicable. Ground truth, in the context of device performance, refers to objective mechanical measurements rather than expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing involves quantitative measurements, not expert adjudication.

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

No, an MRMC study was not done. This is a physical spinal implant system, not a diagnostic or prognostic AI/ML algorithm that would involve human readers interpreting cases.

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

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

7. The Type of Ground Truth Used

For the mechanical performance testing, the "ground truth" would be the objective, quantitative measurements obtained from the physical tests (e.g., force, displacement, cycles to failure) as defined by ASTM F1717. For the design comparison, the "ground truth" was a comparison of design features and sizing against legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm.

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

Not applicable. This is a physical device, not an AI/ML algorithm.

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