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510(k) Data Aggregation
(84 days)
RANGE SPINAL SYSTEM (MESA AND DENALI)
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
| Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | In accordance with ASTM F1717 for static compression, static torsion, and dynamic compression. | Worst case components of the modified implants were tested in static compression, static torsion and dynamic compression in accordance with ASTM F1717 and compared with the original Range Spinal System components. The modified implants were determined to be substantially equivalent to the predicate devices. |
| Material | To meet ASTM and ISO standards for Titanium Alloy and Cobalt Chrome. | The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards. |
| Design/Sizing | Substantially the same as predicate devices. | The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems. |
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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(127 days)
RANGE SPINAL SYSTEM (MESA AND DENALI)
The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples. The Range 4.5mm Small Stature Rod System is indicated for the following:
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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
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, hooks, transverse connectors, and rod connectors (axial, parallel and offset lateral). The screws range from 4.5mm in diameter, 20mml 10mm in length and attach to a 5.5mm rod.
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 provided text describes a 510(k) summary for the Range Spinal System, focusing on modifications. This document outlines the device, its intended use, and a comparison to predicate devices, particularly concerning its mechanical performance.
However, the provided text does not contain information about acceptance criteria for device performance in a clinical or diagnostic context, nor does it describe a study involving human subjects or AI performance. The "study" mentioned is a mechanical bench test comparing the modified implants to previous versions and predicate devices.
Therefore, I cannot populate most of the requested fields as they pertain to clinical performance studies, AI algorithms, human expert evaluation, or statistical analysis of diagnostic accuracy.
Here's a breakdown of what can be extracted and why other fields cannot be filled:
- Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (from text) |
|---|---|
| Mechanical: | "modified implants were tested... in static compression, static torsion and dynamic compression in accordance with ASTM F1717" |
| Not explicitly stated what "passing" values were for specific forces or cycles. | "The modified implants were determined to be substantially equivalent to the predicate devices." (This implies they met mechanical performance comparable to predicates under ASTM F1717.) |
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from the text. The "test set" refers to mechanical samples, not patient data. The text does not specify the number of modified implants tested or their origin.
-
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. No human experts were used to establish "ground truth" for this type of mechanical testing. The "ground truth" is defined by the ASTM F1717 standard itself for mechanical properties.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is relevant for mechanical bench testing.
-
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 mechanical device, not an AI diagnostic tool. No MRMC study was conducted.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a mechanical device, not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" is the performance specifications outlined by ASTM F1717, which dictates how spinal implant assemblies should be tested for static and dynamic properties. The goal was to show "substantial equivalence" to predicate devices, implying performance within an acceptable range defined by industry standards and comparison to previously cleared devices.
-
The sample size for the training set
- Not applicable. This is a mechanical device. There is no "training set" in the context of machine learning or AI.
-
How the ground truth for the training set was established
- Not applicable. As above.
In summary, the provided document details a regulatory submission for modifications to a spinal implant system, focusing solely on the mechanical performance of the modified components compared to existing predicate devices using standardized bench testing. It does not involve any clinical studies, AI, or human performance evaluations.
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(79 days)
RANGE SPINAL SYSTEM (MESA AND DENALI)
The Range Spinal System is comprised of the DENALI, 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 LS-S 1 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 degencration 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 fision.
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 provided document is a 510(k) premarket notification for the Range Spinal System: Mesa Modifications. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. Therefore, the information typically requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment for AI/diagnostic devices will not be present in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Substantial equivalence to predicate Range Spinal System components regarding static compression, static torsion, and dynamic compression as per ASTM F1717. | The modified implants were tested in static compression, static torsion, and dynamic compression in accordance with ASTM F1717. The modified implants were determined to be substantially equivalent to the predicate devices. |
| Design Features and Sizing: | |
| Substantially the same as predicate devices. | The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. The submission relies on mechanical testing of components, not human test subjects or clinical data in the context of diagnostic performance. The sample size for the mechanical tests (e.g., number of screws or rods tested) is not specified in this summary.
- Data Provenance: Not applicable in the context of clinical data. The data provenance is from laboratory mechanical testing.
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. Ground truth as typically understood for diagnostic or AI devices (e.g., expert consensus on medical images) is not relevant for this type of mechanical device submission and testing. The "ground truth" here is compliance with ASTM standards and comparison to a predicate device's mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving human readers or interpretation of results that would require an adjudication method.
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 spinal fixation system, not an AI or diagnostic device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to an AI/algorithm's performance, which is not relevant to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the established performance characteristics and mechanical properties of the legally marketed predicate devices, and the compliance with established ASTM standards (like F1717) for mechanical testing.
8. The sample size for the training set:
- Not applicable. This submission does not involve machine learning or AI models with training sets.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned in this submission.
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(80 days)
RANGE SPINAL SYSTEM (MESA AND DENALI)
The Range Spinal System is comprised of the DENALI, 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 firstien 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-S I 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 tordosis); 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.
Here's the analysis of the provided text regarding the Range Spinal System:
This document is a 510(k) summary for component modifications to an existing device, the Range Spinal System. It does not describe a clinical study in the traditional sense, but rather a mechanical testing comparison to establish substantial equivalence with predicate devices. Therefore, many of the requested categories related to clinical studies and expert review will not be applicable.
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | The modified components of the Range Spinal System must perform equally to or better than the predicate devices in static compression, static torsion, and dynamic compression. This testing is to be conducted in accordance with ASTM F1717. (This is inferred from "The modifications to the Range Spinal System were mechanically tested and compared to predicate devices. The modified component performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.") | The modified component performed equally to or better than the predicate systems in static compression, static torsion, and dynamic compression. |
| Substantial Equivalence | Design Features: Similar to predicate devices. (Inferred from "The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.") | |
| Function: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | ||
| Material: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | ||
| Intended Use: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") | The Range Spinal System's design features and sizing were found to be substantially the same as predicate systems. | |
| The device maintains substantial equivalence to other devices in design, function, material, and intended use. | ||
| There are no significant differences that would adversely affect product use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This was a mechanical engineering test on components, not a clinical study on human subjects or clinical data. The "sample" would be the number of test articles (modified components) subjected to mechanical loads, which is not specified but would follow ASTM F1717 guidelines.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective. The data comes from mechanical laboratory testing of device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for mechanical performance tests is established by adhering to standardized testing protocols (e.g., ASTM F1717) and engineering measurements, not by expert clinical consensus.
4. Adjudication Method for the Test Set
- Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is not a clinical study involving human readers or assessment of AI performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This is not an AI/algorithm-based device.
7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: For mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements of force, displacement, cycles to failure, and other mechanical properties obtained through standardized testing methods (ASTM F1717). The performance of the predicate devices under these same conditions serves as the benchmark.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is not an AI/machine learning device.
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