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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 DPZ Pedicular Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
• Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

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

• Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

4. Adjudication method for the test set:

• Not applicable, as this refers to human reader review and consensus, which was not performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done, as "No clinical studies were performed."

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

• Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

7. The type of ground truth used:

• The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

8. The sample size for the training set:

• Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

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

• Not applicable for the same reason as above.

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The CosmoLock Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

The CosmoLock Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

The CosmoLock Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials:

Ti-6Al-4V per ASTM F136 CoCr per ASTM F1537

This document is a 510(k) Summary for the CosmoLock Pedicle Screw System. It describes the device and its intended use and claims substantial equivalence to predicate devices. However, it does not contain the detailed information needed to answer many of your questions, as it explicitly states that no clinical studies were performed.

Here's an analysis based on the provided text:

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 information is not provided in the document. The studies mentioned are non-clinical (mechanical tests), and details about sample sizes for these tests are not specified.

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)

This information is not applicable/provided. No clinical studies were performed, and therefore no ground truth established by experts is relevant to the data presented.

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

This information is not applicable/provided. No clinical studies were performed.

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 document states, "No clinical studies were performed."

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

This information is not applicable. The device is a mechanical pedicle screw system, not an AI or algorithm-based device. No standalone performance study in this context was performed.

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

The ground truth for the non-clinical tests would be the established mechanical testing standards (ASTM F1717) and the performance of the predicate devices. There is no biological or expert-defined "ground truth" in the typical medical imaging/diagnosis sense, as this is a mechanical implant.

8. The sample size for the training set

This information is not applicable/provided. No clinical studies were performed, and there is no mention of an algorithm or AI requiring a training set.

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

This information is not applicable/provided. No training set or associated ground truth was established, as no clinical studies or AI development are described. The focus is on demonstrating mechanical equivalence to predicate devices.

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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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The XENON Pedicle Screw System is intended for posterior, non-cervical pedicle 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. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft.

The system is comprised of XENON standard polyaxial screws, hightop polyaxial screws, set screws, rods. The XENON polyaxial screw features a dual lead thread, 3 prong drive instrument interface and is self tapping. The polyaxial screws are offered in various diameters ranging from 4.5mm to 8.0mm and lengths ranging from 25mm and 80mm. The polyaxial screws range of motion is 50 degrees Medial/Lateral and 50 degrees Inferior/superior. The 5.5mm diameter rods are offered in lengths 35mm to 600mm. The rods are also offered in two profiles, straight and precontoured. The adjustable bridges are offered in 4 different sizes. The implants are manufactured from surgical grade titanium alloy (Ti6AI-4V).

Here's a breakdown of the acceptance criteria and the study that proves the XENON™ Pedicle Screw System meets them, based on the provided document:

This document is a 510(k) summary for a medical device (XENON™ Pedicle Screw System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results against predefined acceptance criteria for a novel device. Therefore, much of the requested information regarding sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies of AI/diagnostic devices, is not present in this type of submission.

The "acceptance criteria" here are implicitly the performance standards set by recognized consensus standards for spinal implant mechanical testing, and the "proof" is that the device met these standards and was substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing "demonstrated that XENON Pedicle Screw System is substantially equivalent to the predicate Zodiac Polyaxial Spinal Fixation System device." This implies that the XENON system met or exceeded the performance of the predicate device when tested against ASTM F1717. Specific numerical thresholds for these tests are not provided in this summary but would be part of the full test reports.

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

• Test Set Sample Size: Not applicable/not specified in this 510(k) summary. The "test set" here refers to the device specimens used for mechanical testing, not patient data. The number of physical units tested to satisfy ASTM F1717 standards is not disclosed in this summary.
• Data Provenance: Not applicable. This study involves mechanical testing of physical device components, not human data.

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

• Number of Experts: Not applicable. Ground truth as typically defined for AI or diagnostic devices (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by the specifications and outcomes of the standardized tests (ASTM F1717) and the performance of the predicate device.
• Qualifications of Experts: Not applicable. Material scientists, engineers, and technicians would be involved in conducting and interpreting the mechanical tests according to industry standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical testing results are typically objective measurements, not subject to human adjudication in the same way clinical diagnoses or image interpretations are. Calibration and adherence to test protocols ensure consistency.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a pedicle screw system, not an AI or diagnostic tool that requires human interpretation of medical cases. The study was mechanical testing of physical hardware.

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

• Standalone Study: Yes, in a broad sense. The "standalone" performance here refers to the mechanical performance of the device itself, without human intervention once the tests begin. However, this terminology typically applies to AI algorithms. For this device, it implies that the mechanical tests measured the intrinsic properties and performance of the pedicle screws and system components independent of surgical implantation technique (which would involve human-in-the-loop aspects).

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this submission is established by recognized consensus standards (ASTM F1717) for mechanical testing of spinal implants and the demonstrated performance of the predicate device when subjected to these same standards. The "truth" is that the XENON system's mechanical capabilities are equivalent to a device already deemed safe and effective.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission describes mechanical testing, not a machine learning model. There is no "training set" in this context.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of submission.

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