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The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiosraphic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.

The Dymaxeon Spine System is a posterior pedicle screw system designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, connectors and fasteners. The implants are sold sterile.

The provided text is a 510(k) summary for the Dymaxeon Spine System. It focuses on the mechanical testing and substantial equivalence of the device, particularly the new eCarbon rods and rod connectors, to predicate devices. It does not describe a study involving an AI component or a device that has acceptance criteria related to performance metrics like sensitivity, specificity, or accuracy in a diagnostic context.

Therefore, I cannot extract the information required by your prompt, as it is designed for a medical device that utilizes AI and has performance-based acceptance criteria, which this document does not contain.

The document describes the device, its indications for use, materials, and mechanical testing results to demonstrate substantial equivalence, but it does not include:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI outputs.
2. Sample size used for a test set in the context of diagnostic performance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone (algorithm-only) performance.
7. Type of ground truth (expert consensus, pathology, outcomes data) for diagnostic tasks.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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The Dymaxeon Spine 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 of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6A14V per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, and connectors. The Dymaxeon Spine System can be used for single or multiple level fixations.

The purpose of this submission is to obtain clearance for a modification to the tulip and mating set screws.

This document describes a 510(k) premarket notification for the Dymaxeon Spine System, focusing on a modification to the tulip and mating set screws. The submission seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Demonstrate equivalent performance to predicate device for thread change (axial grip testing per ASTM F1798).	"Engineering rationale and non-clinical tests were performed to evaluate the thread change (axial grip testing per ASTM F1798)." (Implies successful demonstration of equivalence, though specific numerical results are not provided in this summary.)

   Note: The provided document is a 510(k) summary, which often provides high-level information. Specific quantitative acceptance criteria and detailed performance results for the axial grip testing (e.g., specific load values, displacement limits, or statistical equivalence margins) are not included in this summary. It only states that tests were performed to "evaluate the thread change" and that the device is "substantially equivalent."

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

   • Test Set Sample Size: This document does not specify the sample size for the "non-clinical tests" (axial grip testing). For mechanical testing, this would typically be a number of pedicle screws tested to failure.
   • Data Provenance: The tests are stated as "non-clinical tests," implying laboratory bench testing. The country of origin for the data is not specified, but it would typically be conducted by or for the manufacturer (Back 2 Basics Direct, LLC) in a testing facility. It is prospective testing, as it's performed to evaluate a new modification prior to market.

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

   • This question is not applicable to this type of submission. The ground truth for mechanical testing of a medical device like a spine system is not established by human expert consensus or clinical outcomes. Instead, it is established by adherence to recognized national or international standards (e.g., ASTM F1798 for axial grip testing) and objective physical measurements and engineering principles. The "truth" is the physical performance of the device under defined conditions.

4. Adjudication Method for the Test Set:

   • This question is not applicable. Mechanical tests are objective and quantitative. There is no need for human adjudication of results in the way there might be for clinical image interpretations. The "adjudication" is based on whether the measured values meet the specified engineering criteria or demonstrate equivalence to the predicate.

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

   • This question is not applicable. The Dymaxeon Spine System is a physical implant (pedicle screws, rods, hooks, connectors) for spine stabilization. It is not an AI-powered diagnostic or assistive technology that would involve human readers or image interpretation. Therefore, an MRMC study is irrelevant to this device.

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

   • This question is not applicable. As stated above, this is a physical implant, not an algorithm or AI system.

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

   • For the mechanical testing performed, the "ground truth" is the objective physical performance of the device components as measured against established engineering specifications and standards (e.g., ASTM F1798). The performance is compared to the known performance of the predicate device.

8. The sample size for the training set:

   • This question is not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical implant. Training sets are relevant for machine learning algorithms.

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

   • This question is not applicable for the same reasons as item 8.

In summary, the provided 510(k) summary focuses on demonstrating mechanical equivalence of a modified Dymaxeon Spine System to existing predicate devices through non-clinical laboratory testing. The criteria for demonstrating equivalence are based on established engineering standards (ASTM F1798). This type of submission does not involve clinical studies with human readers, AI algorithms, or "ground truth" established by expert consensus or pathology in the way that diagnostic devices might.

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The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, soliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The additional Ø5.5mm rod, cannulated screw, transverse connector, and hook components will be used in conjunction with the predicate Dymaxeon Spine System during the fixation of the spine. The components are manufactured from titanium alloy and come in a variety of lengths.

This document is a 510(k) premarket notification for the Dymaxeon Spine System, focusing on adding new components to an existing system. The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to establish acceptance criteria for an AI/CADe device or to present results from a clinical study comparing device performance against such criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable to this document.

This document describes a medical device, which is a physical implant, not an AI/CADe system. The preclinical testing mentioned refers to mechanical testing of the physical components, not software performance.

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The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1 - S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws, reduction screws, and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters.

The provided text describes the Dymaxeon Spine System, a posterior pedicle screw system, and its substantial equivalence to predicate devices based on preclinical testing. It does not describe a study involving humans or AI for diagnostic or predictive purposes. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness with AI assistance is not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not explicitly state numerical acceptance criteria in a table format. However, the reported device performance is that it met the requirements of the ASTM F1717 standard. The acceptance criterion is implied to be "substantially equivalent" to predicate devices, as demonstrated by meeting this standard.

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

This information is not applicable as the described study is preclinical biomechanical testing, not a human reader study or a study using clinical data.

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. Ground truth, in the context of this preclinical testing, would relate to the physical properties and performance of the device against established engineering standards, not expert medical opinions on diagnostic accuracy.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for preclinical 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

This information is not applicable. The provided text describes a medical device (spinal implant) and its preclinical testing, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. This document does not describe an algorithm or AI.

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

The "ground truth" for this preclinical testing was established by standardized biomechanical testing protocols, specifically ASTM F1717. This standard defines methods for testing spinal implant constructs, and meeting its requirements (as compared to predicate devices) serves as the basis for demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of preclinical mechanical testing of a spinal implant. This term is relevant for machine learning algorithms.

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

This information is not applicable for the reason stated above.

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