Search Results

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.

Ask a specific question about this device

The eCarbon-C is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The eCarbon-C is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at one level or two contiguous levels from C2 - T1. The eCarbon-C is to be used with supplemental fixation. The implants are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion.
The eCarbon-P is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, the eCarbon-P can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The eCarbon-P is to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

The eCarbon IBDs are a collection of interbody devices. The cervical implants (eCarbon-C) have basic keystone shape in a columnar form while the lumbar devices (eCarbon-P) are essentially rectangular. All have a central cavity for bone graft and are offered in a variety of height, length, width and lordotic angulation combinations are available to accommodate the anatomic requirements of individual patients.

The provided text is a 510(k) Summary for the eCarbon IBDs, which are intervertebral body fusion devices. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance reporting as one might find for novel AI/imaging devices.

Therefore, the document does not contain the detailed information requested for acceptance criteria, device performance, study types (MRMC, standalone), sample sizes, ground truth establishment, or expert qualifications in the context of an algorithm's performance.

Instead, the "Performance Data" section describes mechanical testing performed to demonstrate that the eCarbon IBDs are mechanically equivalent to their predicate devices.

Here's the information that can be extracted related to performance and testing:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria in terms of a pass/fail threshold. Instead, it states that the test results "demonstrated equivalent mechanical performance... compared to the cited predicate devices under the same test conditions." This implies that the performance of the eCarbon IBDs was expected to be comparable to or better than the predicate devices in the specific tests.

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

• Sample Size: Not explicitly stated for each test, but refers to "worst case eCarbon cervical implant" and "worst case eCarbon lumbar implant," implying a limited number of samples representing the most challenging configurations. These would be physical samples for mechanical testing, not data samples in the context of an AI study.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country, retrospective/prospective). This refers to laboratory mechanical testing.

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. "Ground truth" in this context would refer to established mechanical testing standards (ASTM F2077, ASTM F2267) which define how the performance is measured, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. Mechanical tests follow predefined protocols, and the results are quantitative measurements, not subjective interpretations requiring adjudication.

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 (intervertebral body fusion devices) for which mechanical performance, not AI-assisted image interpretation, is being evaluated.

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

Not applicable. This device is not an algorithm, but a physical implant.

7. The type of ground truth used:

The "ground truth" for mechanical testing is established by recognized industry standards (ASTM F2077, ASTM F2267) and the physical properties and behavior of the identical predicate devices.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI device.

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

Not applicable. There is no "training set" as this is not an AI device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device