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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

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

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

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

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

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

• MRMC Study: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

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

• No. (This device is a spinal fixation system, not an algorithm.)

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

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

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

• N/A (Not applicable for this type of submission.)

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is to add rod to rod connectors and lateral rod connectors to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

This document describes a 510(k) premarket notification for the Coral™ Spinal System by Theken Spine, LLC. It aims to add rod-to-rod and lateral rod connectors to an already approved system. The submission emphasizes substantial equivalence to existing predicate devices based on design, materials, indications for use, and manufacturing processes.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. The document is a regulatory submission for a medical device that focuses on demonstrating substantial equivalence to previously approved devices, primarily through comparison of design, materials, and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The sections below will indicate that the information is not available in the provided document.

Acceptance Criteria and Device Performance Study Information

The provided document is a 510(k) summary for a medical device (Coral™ Spinal System) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results. Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Information Not Available in the Provided Text. The document does not describe specific acceptance criteria or report performance metrics for the Coral™ Spinal System beyond declaring it substantially equivalent to predicate devices.

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

• Information Not Available in the Provided Text. No test set, data provenance, or sample sizes related to a performance study are mentioned. The submission relies on design, material, and functional comparisons for substantial equivalence.

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

• Information Not Available in the Provided Text. The document does not describe a performance study involving ground truth establishment by experts.

4. Adjudication method for the test set

• Information Not Available in the Provided Text. No adjudication method for a test set is described.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system. Performance is assessed through mechanical testing and comparison to predicate devices, not through standalone algorithm performance.

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

• Information Not Available in the Provided Text. No ground truth for a performance study is mentioned as no such study is detailed.

8. The sample size for the training set

• Information Not Available in the Provided Text. No training set is mentioned as the document is not describing a machine learning or AI-based device.

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

• Information Not Available in the Provided Text. No ground truth for a training set is mentioned.

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The Vu e.POD Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (ie. fracture).

The Vu e.POD Vertebral Body Replacement is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.

The Vu e.POD Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the Theken Surgical. LLC, BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Surgical, LLC, Coral Spinal System (K041592, Approved 9/04).

The Vu e•POD Vertebral Body Replacement is comprised of PEEK concave cages with fenestrations and radii on all sides and toothed spikes used in combination with a titanium spacer component. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the concave cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. The Vu e•POD Vertebral Body Replacement may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the construct oriented vertically.

The provided documentation describes a 510(k) submission for the "Vu e•POD Vertebral Body Replacement" device. 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 reporting of reader performance. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and reader performance (human or AI) is not typically part of a 510(k) summary for a spinal implant.

Instead, the submission focuses on demonstrating that the new device has the same indications for use, basic design, operating principle, materials, surgical techniques, supplemental fixation requirements, manufacturing environment, sterilization process, and packaging configurations as the predicate devices. The "study" mentioned is primarily a series of mechanical tests and design comparisons rather than a clinical trial.

Here's a breakdown based on the provided text, addressing your points where possible and noting where the information is not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device, not necessarily quantitative performance metrics against a predefined clinical or diagnostic standard in the way an AI/diagnostic device might have. The "device performance" is therefore implicitly that it functions equivalently to the predicate devices.

Note: The above table reflects the criteria for demonstrating substantial equivalence, which is the core "acceptance criterion" for a 510(k) device. Specific quantitative performance metrics like sensitivity, specificity, or reader improvement in an MRMC study are not applicable to this submission type.

Study Details (as inferable from a 510(k) for a spinal implant):

1. 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 in the context of a clinical trial. The "test set" here would refer to the physical devices subjected to mechanical testing. The number of devices tested is not specified but would typically follow ISO/ASTM standards for medical device testing.
   • Data Provenance: Not applicable. The "data" primarily consists of mechanical test results and material characterization, not patient data.

2. 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" in the clinical/diagnostic sense is not established for this type of device. The ground truth for mechanical testing would be established by validated test methods and engineering principles. Expertise would come from engineers/scientists performing the tests, not medical professionals interpreting diagnostic data.

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

   • Not applicable. This concept pertains to resolving discrepancies among expert readers in diagnostic studies. For mechanical testing, resolution of discrepancies would follow standard engineering practices or test method protocols.

4. 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, an MRMC study was not done, and it is not relevant for this type of device (a vertebral body replacement implant). This is a surgical implant, not a diagnostic AI device.

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

   • No, a standalone algorithm performance study was not done. This device is not an algorithm or AI.

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

   • Not applicable in the clinical/diagnostic sense. For the mechanical testing performed, the "ground truth" is based on established engineering principles, material specifications (ASTM standards for PEEK, Tantalum, Titanium), and validated test protocols designed to assess mechanical properties like strength, fatigue, and stability.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an algorithm or AI for this device.

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

   • Not applicable. There is no "training set" for this device.

In summary: The provided document is a 510(k) summary for a medical implant, the Vu e•POD Vertebral Body Replacement. Its regulatory pathway relies on demonstrating "substantial equivalence" to existing cleared predicate devices, primarily through comparison of design, materials, indications for use, and mechanical testing, rather than extensive clinical trials or performance assessments against specific diagnostic criteria. Therefore, most of the questions pertaining to AI/diagnostic study design (like sample size, number of experts, ground truth, MRMC studies) are not applicable to this submission.

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The x•POD Adjustable Vertebral Body Replacement is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (e.g., fracture).

The x•POD Adjustable Vertebral Body Replacement is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. It is recommended that bone graft material be packed in the interior openings of the device prior to implantation.

The x•POD Adjustable Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems, such as the BodyForm Thoracolumbar Fixation System (K983622, SE 12/98) or Coral Pedicle Screw System (K041592, SE 9/04).

The x•POD Adjustable Vertebral Body Replacement is comprised of a cylindrical titanium (Ti-6Al-4V) mechanism with rectangular endplates. The system has fenestrations axially and laterally to maximize bone graft placement. The implants are manufactured in a variety of geometric combinations to better fit each patient's pathology. The anatomically designed endplates are designed to minimize expulsion and rotation of the implant postoperatively. The x•POD Adjustable Vertebral Body Replacement is manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136 and ISO 5832-3 standards. The x•POD Adjustable Vertebral Body Replacement construct is used individually and is always implanted with the construct oriented vertically.

This is a 510(k) premarket notification for a spinal implant device (x•POD Adjustable Vertebral Body Replacement), not a diagnostic AI device. Therefore, the provided text does not contain information about acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the approval process for this type of medical device.

The approval is based on "substantial equivalence" to legally marketed predicate devices, meaning it has similar intended use, design, and physical characteristics, and performs comparably in mechanical testing, not through clinical performance metrics like sensitivity or specificity.

Therefore, I cannot provide the requested information.

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The Theken VU MESH VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or otherwise unstable vertebral body due to tumor or trauma (i.e. fracture).

The Theken VU MESH VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. Bone graft material is recommended for packing in the interior opening of the device prior to implantation.

The Theken VU MESH VBR SYSTEM is intended for use with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622, Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

The Theken Vu Mesh VBR system is comprised of square footprint polymer cages with fenestrations axially and laterally. It includes toothed endplates, which are used in combination with optional spacer components to extend the range of the cage in smaller increments. The cages, spacers and endplates can be assembled in a variety of combinations to fit each individual patient's pathology. The toothed endplates engage with the superior and inferior endplates of the neighboring vertebral bodies to resist rotation and migration. The Vu Mesh cage may be used individually or in a pair depending on the surgical need, however, the device is always implanted with the mesh cage oriented vertically.

This is a 510(k) summary for a medical device called the "Theken Vu Mesh VBR System," which is a vertebral body replacement device. 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the requested information regarding acceptance criteria, study details, and human reader performance with AI assistance is not available in this document.

This document primarily outlines:

• Device Information: Trade name, common name, classification, materials, and description.
• Intended Use: For thoracolumbar spine (T1-L5) to replace unstable vertebral bodies due to tumor or trauma, to restore biomechanical integrity, and for use with supplemental spinal fixation systems.
• Predicate and Comparative Devices: A list of previously cleared devices to which the Vu Mesh VBR System claims substantial equivalence.
• Substantial Equivalence Argument: The argument is based on similarities in intended use, design, physical characteristics, and material composition to existing devices. Mechanical testing and engineering analysis are mentioned as part of the evidence.

Therefore, I cannot provide the specific details about acceptance criteria and study data as requested because this information is not typically included in a 510(k) summary focused on substantial equivalence.

For completeness, if this were a document that did contain such a study, here's how I would apply your requested framework (displaying what would be absent in this specific document):

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: (Not available in this 510(k) summary)
• Data Provenance: (Not available in this 510(k) summary. Given the nature of a 510(k) for an implant, any testing would likely be bench testing rather than clinical data from human subjects unless specifically required for novel aspects.)
  • If clinical data were involved, it would specify: e.g., "Retrospective, multi-center data from 3 US hospitals" or "Prospective, single-center study in Germany."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: (Not available in this 510(k) summary)
• Qualifications of Experts: (Not available in this 510(k) summary)
  • If applicable, this would state: e.g., "3 board-certified orthopedic surgeons with >15 years of experience in spinal surgery."

4. Adjudication Method for Test Set

• Adjudication Method: (Not available in this 510(k) summary)
  • If applicable, this would state: e.g., "2+1 consensus: two readers independently reviewed cases, and a third senior reader resolved disagreements."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, this document does not describe an MRMC study.
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC study with AI assistance is described.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No, this document describes a physical medical device (vertebral body replacement system), not an algorithm or AI. Performance is assessed through substantial equivalence to existing devices and mechanical testing.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not applicable as this is a physical device and the 510(k) focuses on substantial equivalence based on design and materials, supported by mechanical testing, rather than an AI/diagnostic algorithm using clinical ground truth.)
  • If applicable (e.g., for an AI diagnostic device), this would specify: e.g., "Pathology reports (gold standard)" or "Clinical outcomes data (e.g., patient follow-up over 12 months)."

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for Training Set Was Established

• Method for Establishing Ground Truth: Not applicable. This is not an AI/ML device that requires a training set with established ground truth.

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The Theken VU VBR SYSTEM is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The Theken VU VBR SYSTEM is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absences of fusion for a prolonged period. Bone graft material is recommended to be packed into the interior openings of the device prior to implantation.

The Theken VU VBR SYSTEM is intended to be used with supplemental internal spinal fixation systems, such as the Theken BodyForm Thoracolumbar Fixation System (K983622), Approved 12/98) or the Theken Coral Pedicle Screw System (K041592, Approved 9/04).

The Theken VU VBR SYSTEM is comprised of rounded rectangular and rectangular cages with fenestrations and radii on all sides and toothed spikes which are used in combination with spacer components. The cages and spacer can be locked together into a variety of geometric configurations to fit each individual patient's pathology. The toothed spikes of the rounded rectangular and rectangular cages engage with the superior and inferior end plates of the neighboring vertebral bodies to resist rotation and migration. A single construct is sufficient to be used at all spinal levels and pathologies.

The provided document is a 510(k) summary for the Theken VU VBR SYSTEM, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish acceptance criteria for device performance in terms of accuracy, sensitivity, or specificity.

Therefore, the document does NOT contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The 510(k) summary explicitly states: "Establishment of equivalence is based on similarities of intended use, design, and physical characteristics. All implants are used to treat the same conditions, have essentially the same precautions and contradictions for use, and have equivalent potential for complications for the risk of use. In addition they all represent a basic design concept in terms of safety and effectiveness, and differ only in minor details. Based on the design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis (adherence to GLP), Theken Surgical believes that sufficient evidence exists to reasonably conclude that the VU VBR SYSTEM is substantially equivalent to existing legally marketed devices."

The study that "proves the device meets the acceptance criteria" in this context refers to the comparison against predicate devices and mechanical testing, not a clinical study to establish diagnostic performance. The "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity but rather as conformity to the design, materials, and intended use of equivalent devices already on the market and adherence to good laboratory practices (GLP) for mechanical testing.

Since this is a medical device and not an AI/algorithm-based diagnostic tool, many of the requested fields are not applicable to this type of regulatory submission.

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