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The Trabecular Metal 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 Trabecular Metal Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

The Trabecular Metal 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 Trabecular Metal Vertebral Body Replacement (VBR) System is comprised wholly of Trabecular Metal Porous Tantalum. 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 provided 510(k) summary for the Trabecular Metal Vertebral Body Replacement System focuses on demonstrating substantial equivalence to predicate devices based on mechanical performance and biocompatibility. It does not describe a study involving acceptance criteria for device performance based on diagnostic accuracy or clinical outcomes, as would be the case for AI/ML-enabled devices.

Therefore, many of the requested fields are not applicable to this submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a vertebral body replacement system, the "performance" here refers to mechanical and biocompatibility data, not diagnostic accuracy. The acceptance criteria would likely be specified in the cited standards and in comparison to the predicate devices.

Study that proves the device meets the acceptance criteria:
The submission states, "Predicate devices that are a part of the Trabecular Metal Performance Data: Vertebral Body Replacement System were tested per applicable standards (reference K010378 and current submission)." It also mentions, "Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicate devices."

The results demonstrated that the device "will perform as intended and is equivalent to the cited predicate devices." This implies that the acceptance criteria for mechanical properties (e.g., maximum deflection, load-bearing capacity, fatigue life as defined by the applicable standards) were met, and the biocompatibility data was deemed acceptable by the FDA.

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

Not Applicable (N/A). This submission is for a physical implant, not an AI/ML-enabled device or a diagnostic tool that uses a "test set" of patient data. The "test set" would consist of physical devices tested in a lab. The number of devices tested for each mechanical performance criterion is not specified but would be conducted according to relevant ASTM or ISO standards for medical implants.

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

N/A. Ground truth in this context would be objective physical measurements of the device's mechanical properties or biological response in biocompatibility tests, not expert interpretation of images or clinical data.

4. Adjudication method for the test set

N/A. Adjudication methods are typically for resolving discrepancies in expert interpretations of data (e.g., in radiological reads). This is not relevant for mechanical testing or biocompatibility assessment of a physical implant.

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

N/A. This is a physical implant, not an AI-assisted diagnostic or clinical decision support tool.

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

N/A. This is a physical implant, not an algorithm.

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

For mechanical performance, the "ground truth" would be the objective measurements of force, displacement, cycles, wear, etc., obtained through standardized laboratory testing procedures. For biocompatibility, the "ground truth" would be established through laboratory assays and animal studies according to ISO 10993 or equivalent standards.

8. The sample size for the training set

N/A. This is a physical implant, not an AI/ML model that requires a training set.

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

N/A. This is a physical implant, not an AI/ML model.

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The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Hedrocel Trabecular Metal Reconstruction The System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds components with a variety of cross-sections and heights to the Hedrocel Trabecular Metal Reconstruction System.

Here's an analysis of the provided text regarding the Hedrocel Trabecular Metal Reconstructive System:

Summary of Acceptance Criteria and Study Details:

Based on the provided 510(k) summary, the device is a surgical mesh (The Hedrocel Trabecular Metal Reconstructive System) made of Hedrocel porous tantalum. The core of the submission relies on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance acceptance criteria for a novel device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical trials or algorithm validation. The "testing" refers to mechanical performance tests of the material itself. The document mentions "mechanical test data found in MAF #920," implying laboratory-based material characterization, not patient data.
• Data Provenance: Not applicable in the context of clinical data. The mechanical test data would be lab-generated.

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

• Not Applicable. This submission focuses on demonstrating substantial equivalence through material properties and mechanical testing, not through expert-verified clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no mention of adjudication, as this wasn't a clinical performance study requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is not mentioned. The submission is for a medical device (surgical mesh) and its mechanical performance, not an AI or imaging diagnostic tool that would typically involve human readers.

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

• No. This is not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the material's performance is derived from laboratory mechanical testing that quantifies properties like strength, and comparison to existing standards and predicate device performance. It is not based on expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the manufacturing process and material composition.

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

• Not Applicable. See point 8.

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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.

This document describes the 510(k) summary for the Hedrocel® Vertebral Body Replacement System. However, this is a medical device submission, not a study of an AI-powered device. Therefore, many of the requested categories for AI device evaluation are not applicable. I will extract the relevant information regarding acceptance criteria and performance data as presented in the provided text.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary for the Hedrocel Vertebral Body Replacement System focuses on demonstrating substantial equivalence to predicate devices through mechanical and biocompatibility testing, rather than a clinical study with specific performance metrics like sensitivity, specificity, or accuracy for an AI product.

Study Details (as applicable to a medical device submission of this nature)

Since this is a submission for a spinal implant and not an AI-powered diagnostic/therapeutic device, many of the typical AI study parameters are not relevant or not detailed in this type of regulatory document.

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

   • Sample size: Not explicitly stated as a "test set" in the context of human subjects or data. The testing refers to mechanical and biocompatibility evaluations of the device itself.
   • Data provenance: Not applicable. The "data" refers to the results of engineering and material science tests.

2. 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 testing is established by engineering standards and measurements, not expert human interpretation.

3. Adjudication method for the test set:

   • Not applicable. No human adjudication is mentioned for mechanical testing.

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:

   • Not applicable. This is not an AI device.

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

   • Not applicable. This is a physical medical implant, not an algorithm.

6. The type of ground truth used:

   • For biocompatibility: Biological assays and in-vitro/in-vivo studies conforming to established standards for medical device materials.
   • For mechanical performance: Engineering measurements (e.g., force, displacement, wear) using standardized test methods and equipment, compared against performance of predicate devices.

7. The sample size for the training set:

   • Not applicable for a physical device. There is no "training set" in the AI sense.

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

   • Not applicable.

Overall Conclusion from the document:

The Implex Hedrocel Vertebral Body Replacement System demonstrated sufficient mechanical performance and biocompatibility to be considered substantially equivalent to already legally marketed predicate devices (K010378, K021025, K021967). The device was tested per applicable standards, and the provided results indicated it performs as intended and is equivalent to the predicates.

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