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Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The Hedrocel Vertebral Body Replacement System is a medical device designed to replace a diseased or damaged vertebral body in the thoracic and lumbar spine. The acceptance criteria and performance of the device are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing and biocompatibility data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample size used for the mechanical performance tests. It states that "Predicate devices that are a part of the Hedrocel Vertebral Body Replacement System were tested per applicable standards (reference K010378)." It also mentions "Performance testing was provided to support equivalent mechanical behavior to the predicate devices."

Data Provenance: The data appears to be from retrospective testing of the device and its predicate components/materials, conducted by the manufacturer, Implex Corp., in the United States (as indicated by the submission to the U.S. FDA).

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

Not applicable for this type of device. The "ground truth" for mechanical performance and material safety is established through adherence to recognized mechanical testing standards and biocompatibility testing guidelines, rather than expert consensus on imaging or clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., medical imaging) to resolve disagreements among experts. This submission focuses on objective mechanical and biocompatibility testing.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or screening devices where human readers interpret results, often with and without AI assistance, to assess improvements in diagnostic accuracy. This submission concerns a surgical implant, not a diagnostic tool requiring human interpretation of results.

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

Not applicable. This device is a physical surgical implant, not an algorithm or AI system. Its performance is evaluated through physical mechanical tests and biocompatibility, not through algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Mechanical Testing Standards: Established engineering standards for evaluating the static and dynamic strength, fatigue, and wear characteristics of spinal implants. The "ground truth" is that the device must meet or exceed the performance of predicate devices or established safety thresholds defined by these standards.
• Biocompatibility Standards: Standards to ensure the material (Hedrocel Porous Tantalum) is safe for implantation in the human body and does not elicit adverse biological responses. The "ground truth" is that the material must demonstrate satisfactory biocompatibility as per relevant ISO or ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This submission does not describe a training set in the context of machine learning or AI. The term "training set" is not relevant here as the device is a physical implant, not an AI or algorithm. The development of the device likely involved engineering design iterations and material selection, but not a "training set" in the computational sense.

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

Not applicable. As a training set for an AI or algorithm is not relevant, the establishment of ground truth for such a set is also not applicable. The design and validation of the Hedrocel VBR System would have relied on engineering principles, materials science data, and pre-clinical testing to optimize its mechanical properties and biocompatibility.

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The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.
The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.
The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.
The use of titanium or titanium alloy instrumentation is recommended.

This document describes the Implex Hedrocel® Vertebral Body Replacement System, a medical device, and its 510(k) premarket notification. The information provided focuses on the regulatory submission and does not describe a clinical study in the typical sense (e.g., relating to AI device performance). Instead, it describes engineering performance tests to demonstrate substantial equivalence to previously approved predicate devices.

Here's the breakdown based on your request, adapted to the nature of the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on demonstrating "equivalent mechanical behavior" to predicate devices, as assessed by various tests. The "reported device performance" refers to the successful outcomes of these tests.

Study Details (Adapted for this type of device submission)

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

   • Test Set Sample Size: The document does not specify the exact number of physical device units tested for each mechanical test. However, it implicitly refers to a "test set" of devices that underwent the described mechanical and biocompatibility evaluations.
   • Data Provenance: The data was generated through laboratory testing of the Hedrocel® Vertebral Body Replacement System. This is a prospective generation of engineering test data for regulatory submission. The country of origin for the testing is not specified, but the submission is to the US FDA.

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

   • This is not applicable in the context of this device and its testing. "Ground truth" usually refers to clinical classifications or diagnoses. Here, the "truth" is established by adherence to engineering standards and by comparing the device's mechanical performance to established predicate devices under controlled laboratory conditions. The experts involved would be engineers and material scientists conducting and evaluating the tests, but no specific number or detailed qualifications are provided in this summary.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical image interpretation where there might be disagreement among human readers. For engineering performance tests, the results are typically quantitative measurements and comparisons against predefined standards or predicate device performance.

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, a MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-powered diagnostic or assistive tool.

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

   • No. This concept is not applicable as this is not an algorithm or AI device. The device's performance is standalone in the sense that its mechanical properties were tested directly.

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

   • The "ground truth" for this submission is established through objective engineering measurements and compliance with recognized industry standards, alongside comparison to the established mechanical performance characteristics of predicate devices. Biocompatibility data would also adhere to specific material science standards.

7. The sample size for the training set:

   • This concept is not applicable to this device submission. "Training set" refers to data used to train an AI algorithm. The Hedrocel® system is a mechanical implant and does not involve AI.

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

   • This concept is not applicable, as there is no training set for an AI algorithm.

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The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated. The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine. The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine. The use of titanium or titanium alloy instrumentation is recommended.

The provided text describes a 510(k) premarket notification for the "Hedrocel Vertebral Body Replacement System." This is a medical device, and the acceptance criteria mentioned are related to its mechanical performance and biocompatibility, demonstrating substantial equivalence to predicate devices. The document does not describe a study involving human subjects or AI; therefore, many of the requested fields are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Static compression
• Dynamic compression
• Static torsion
• Dynamic torsion
• Abrasion | Test data provided regarding these aspects, demonstrating the device will perform as intended and is equivalent to cited predicate devices. |

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

The document does not specify sample sizes for mechanical testing. The data provenance is not explicitly stated beyond "Performance Data: The Hedrocel Vertebral Body Replacement System was tested per applicable standards (reference K010378)." This suggests laboratory-based mechanical testing, not clinical data from patients.

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

Not applicable. The ground truth for this device's performance is established through engineering standards and mechanical testing, not expert interpretation of clinical data in the context of AI.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical outcomes or image interpretations.

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

Not applicable. This submission is for a medical implant device, not an AI or diagnostic tool that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical implant, not an algorithm. The performance data refers to the mechanical integrity and biocompatibility of the implant itself.

7. Type of Ground Truth Used

The ground truth used for validating the device's performance primarily relied on engineering standards and direct physical measurements obtained through mechanical testing (static and dynamic compression, torsion, abrasion) and biocompatibility assessments. It is compared to the established performance of predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not a study involving machine learning where a "training set" would be used.

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

Not applicable.

Ask a specific question about this device

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.

The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.

The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The use of titanium or titanium alloy instrumentation is recommended.

The provided text describes a 510(k) premarket notification for a medical device, the Hedrocel Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study to prove efficacy and safety with specific acceptance criteria related to a new device performance.

Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable to this type of regulatory submission and is not present in the provided document.

Here's a breakdown of what can be extracted from the text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" and "reported device performance" are primarily focused on demonstrating mechanical equivalence to predicate devices. The acceptance criteria are implicit in the "applicable standards" referenced, and the "reported device performance" refers to the device meeting the mechanical safety and performance benchmarks set by those standards and the predicate devices.

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

• Sample Size for Test Set: Not specified. The document states "test data was provided regarding" various mechanical tests, but doesn't detail the number of units tested.
• Data Provenance: Not specified. These are likely in vitro mechanical tests conducted in a laboratory setting, not clinical data from patients in a specific country.

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

• Number of Experts: Not applicable. For mechanical performance testing, "ground truth" is established through engineering and biomechanical testing against defined standards, not expert clinical consensus on images or outcomes.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This concept is relevant for clinical studies involving expert review, not for mechanical bench testing.

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

• MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, and is not relevant to the mechanical performance of a vertebral implant.
• Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this device's performance is based on biomechanical and material science standards and benchmarks established by the predicate devices. These standards define acceptable levels of static compression, dynamic compression, static torsion, dynamic torsion, and abrasion.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This refers to training an AI model, which is not relevant to this device submission.

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

• How Ground Truth Was Established: Not applicable.

Summary of Inapplicability:

The requested information (points 2-6, 8-9) largely pertains to the validation of AI/software devices or clinical efficacy studies. The K021025 submission for the Hedrocel Vertebral Body Replacement System is a 510(k) for a physical implant, demonstrating substantial equivalence through mechanical and biocompatibility testing against predicate devices and applicable standards. This process does not involve clinical "test sets" or "training sets" in the traditional sense of AI/diagnostic imaging validation.

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