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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, lyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediativ pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The Arsenal Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

The purpose of this Special 510(k) Premarket Notification is to add cannulated implants and MIS rods to the currently marketed Arsenal Spinal Fixation System.

The provided text is a 510(k) Premarket Notification for the Arsenal™ Spinal Fixation System. This document is a regulatory submission for a medical device and, as such, does not contain information on acceptance criteria for an AI/algorithm-driven device or a study proving that an AI device meets acceptance criteria.

The document discusses a spinal fixation system, which is a physical implant, not a software or AI-based device. The "Performance Data" section refers to mechanical testing (e.g., ASTM F 1717, ASTM F1798) to demonstrate the physical device's equivalence to predicate devices, not performance metrics of an AI.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device from this document.

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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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.

When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatic pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The Arsenal Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

The purpose of this Traditional 510(k) Premarket Notification is to add deformity implants to the currently marketed Arsenal Spinal Fixation System and expand the current pediatric indication of the Arsenal System to include treatment of progressive spinal deformities.

The provided text is a 510(k) premarket notification summary for the Alphatec Spine, Arsenal Spinal Fixation System. This document is a regulatory filing for a medical device and does not describe the acceptance criteria or a study proving the device meets performance claims related to diagnostic accuracy or clinical outcomes.

Instead, it focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that FDA has already approved. The "performance data" mentioned refers to mechanical and engineering tests, not clinical studies in the typical sense of evaluating diagnostic performance or clinical improvement in patients.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC studies. The document simply does not contain this type of information.

The only "performance data" mentioned is:

• ASTM F1717 Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsion Tests
• ASTM F1798 Static Flexion-Extension Moment (My) and Axial Gripping Capacity (FX)
• Axial & Maximum Angle Screw Body Pulloff Testing

These are biomechanical tests to assess the physical properties and strength of the spinal fixation system components. The "acceptance criteria" for these tests would typically be compliance with the standards (e.g., passing limits defined in the ASTM standards), but the specific numerical criteria and results are not provided in this summary.

In summary, the provided document does not contain the information required to populate the requested table and details about a study demonstrating device performance in a clinical or diagnostic context.

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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain 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; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The CBx screws are to be included in the currently marketed Arsenal Spinal Fixation System which is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of screws, rods, and connectors that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The CBx screws are made of Titanium Alloy (Ti 6Al 4V ELI) and are designed for placement in the cortical areas of the pedicle where the bone is typically harder, stronger and stiffer than the cancellous portion of the pedicle/vertebra. The threadform of the CBx screws allows the surgeon to use the screw that best suits the patient's anatomy where either cortical bone or both cortical bone and cancellous bone are present.

The provided text describes a 510(k) premarket notification for the "Arsenal Spinal Fixation System," specifically introducing CBx screws as part of this system. This document is focused on demonstrating substantial equivalence to predicate devices for a medical device (pedicle screw system), not an AI or software device.

Therefore, the information typically requested in an acceptance criteria and study section for an AI/software device (e.g., sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, ground truth establishment methods) is not applicable to this document. The document describes mechanical performance testing to prove substantial equivalence for a physical medical implant.

However, I can extract the relevant performance data and acceptance criteria as presented in the document concerning the mechanical aspects of the device.

Acceptance Criteria and Device Performance for the Arsenal™ Spinal Fixation System (CBx screws)

The document focuses on demonstrating substantial equivalence of the CBx screws to existing predicate devices (Zodiac Spinal Fixation System, K100685, and Arsenal Spinal Fixation System, K133221) based on mechanical performance. The "acceptance criteria" are implied by the performance of the predicate devices and the relevant ASTM standards, where the CBx screws must perform equivalently.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression Bending Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
  | ASTM F1717
• Dynamic Compression Bending Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
  | ASTM F1717
• Static Torsional Test | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
  | ASTM F1798
• Flexion extension moment (My) | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |
  | ASTM F1798
• Flexion extension moment fatigue run out (My) | Performance substantially equivalent to predicate devices (Zodiac and Arsenal Systems). | Test results demonstrate that the performance and functionality of the CBx screws are substantially equivalent to the Zodiac System and Arsenal System screws. |

Study Description:

The study conducted was a mechanical performance testing program, rather than a clinical or AI performance study.

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

• Sample Size: Not explicitly stated in terms of number of physical screws tested. The document generally refers to "the CBx screw" undergoing testing. Typically, mechanical tests for medical devices involve a statistically significant number of samples, but the exact count is not provided here.
• Data Provenance: The tests were conducted to specific ASTM standards (ASTM F1717 and ASTM F1798). The data originates from laboratory mechanical testing of the physical device components. Country of origin for the data is not specified, but it would have been generated in a testing facility. The nature of the testing is by definition prospective for the device being evaluated, as the tests are performed on newly manufactured devices to assess their properties.

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

• Not applicable. This relates to mechanical performance, not diagnostic interpretations or clinical outcomes requiring human expert "ground truth." The "ground truth" is defined by the objective physical properties and performance metrics measured according to established engineering standards.

4. Adjudication method for the test set:

• Not applicable. This refers to methods for resolving discrepancies in expert opinions, which is not relevant for mechanical 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:

• Not applicable. This is a physical medical device, not an AI system or diagnostic tool used by human readers.

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

• Not applicable. This is a physical medical device, not an independent algorithm.

7. The type of ground truth used:

• For mechanical performance, the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, as outlined by the specified ASTM standards. The performance of the predicate devices under the same tests serves as the benchmark for "substantial equivalence."

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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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The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

The Arsenal Spinal Fixation System is a Class III non-cervical, posterior approach pedicle screw system. The Arsenal Spinal Fixation System allows surgeons to perform posterior thoracolumbar spine fusion utilizing both implants for fixation and ergonomic instruments to meet the surgeon's needs.

This traditional 510(k) submission adds a new pedicle screw system to Alphatec Spine's current offering and provides the following:

• Polyaxial, Reduction, Sacral, and Cortical non-cannulated, titanium, self-tapping, pedicle . screws
• Cancellous, Sacral, and Cortical dual lead threadforms ●
• Titanium set screws .
• Straight and pre-contoured rods in titanium and cobalt chromium .
• Titanium connectors which include Variable Bridges, Offset Connectors, Revision Connectors, Axial Connectors and Domino Connectors
• . Instrumentation necessary to perform posterior fixation system procedures
• . Connects with other Alphatec Spine systems to provide fixation for the entire spine

The Arsenal Spinal Fixation System is a mechanical device, and its performance is evaluated through non-clinical mechanical testing rather than studies involving human or animal subjects or complex AI algorithms. Therefore, many of the typical acceptance criteria and study details requested for an AI/ML medical device submission are not applicable here.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for component and system-level tests and depend on the variability of the material and design, aiming to demonstrate reliability and robustness.
• Data Provenance: Not applicable in the context of typical clinical data provenance (such as country of origin, retrospective/prospective). This refers to non-clinical laboratory testing performed to established ASTM standards.

3. 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 device testing is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for mechanical properties and performance. These standards define the test methods and what constitutes acceptable performance for spinal fixation systems.

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

• Not applicable. This concept pertains to methods used to resolve disagreements among human reviewers of clinical data. For mechanical testing, results are quantitative and objective, measured by laboratory equipment against defined pass/fail criteria within the ASTM standards.

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 purely mechanical device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. There is no algorithm or AI component in this device.

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

• The "ground truth" for this device's performance is defined by the established benchmarks and criteria within specific ASTM International standards (e.g., ASTM F1717, ASTM F1798) for spinal implant mechanical performance. These standards are developed through a consensus process by experts in the field.

8. The sample size for the training set:

• Not applicable. This is a physical medical device undergoing mechanical testing, not an AI/ML algorithm requiring a training set.

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

• Not applicable, as there is no training set for this type of device.

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