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The Trabecular Metal Vertebral Body Replacement System is comprised of vertebral body replacement devices 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 (VBR) System is designed to be used as a replacement for a diseased or damaged vertebral body and the adjacent disc when spinal surgery is indicated. The Trabecular Metal VBR System is wholly comprised of Trabecular Metal Porous Tantalum deposited on a vitreous carbon skeleton) and is available in a variety of configurations to accommodate the anatomical requirements of different patients.

This document does not contain information about studies that prove the device meets acceptance criteria as typically found for AI/ML medical devices.

The provided text (K070754) is a 510(k) summary for a physical medical device: the "Trabecular Metal™ Vertebral Body Replacement System." This type of device is a physical implant, not an AI/ML diagnostic or prognostic tool.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, MRMC studies, or standalone algorithm performance does not apply to this document.

The "Performance Data" section states: "The results of testing and analyses conducted demonstrate that the worst cases of the proposed System adequately meet the predetermined requirements established for its mechanical performance."

This refers to mechanical and material testing (e.g., fatigue strength, compression testing, biocompatibility) for a physical implant, not the kind of performance data, acceptance criteria, or study design relevant to AI/ML algorithms.

To directly answer your request based on the provided text, while acknowledging it's not an AI/ML device:

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

2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical implants, not data from a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant to mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 physical implant, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For a physical device, the "ground truth" would be established engineering standards and specifications.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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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 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 ropidoo a conalization Metal Vertebral Body Replacement is intended from tradition of the rital internal spinal fixation systems. The Trabecular Metal Vertebral Body Replacement may be used with bone graft.

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 text is a 510(k) summary for a medical device (Trabecular Metal Vertebral Body Replacement System), which focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical and biocompatibility testing. It does not describe a study involving algorithms, human readers, or assessment of clinical performance using metrics like accuracy, sensitivity, or specificity. Therefore, I cannot extract information related to acceptance criteria and device performance in the context of AI/algorithm evaluation.

The sections you requested (1-9) are typical for the evaluation of AI/ML-driven medical devices, especially those that process image data or make diagnostic predictions. This 510(k) pertains to a physical implantable device, and its evaluation relies on different types of evidence.

Here's what I can infer from the provided text relevant to a physical device, even though it doesn't fit the requested AI/ML framework:

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

The document states that "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." However, specific numerical acceptance criteria (e.g., minimum compression strength, torsion resistance) and the exact reported performance values are not detailed in this summary. It only lists the types of tests performed.

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

• Test Set (for mechanical & biocompatibility testing): The sample sizes for each mechanical test (static compression, dynamic compression, static torsion, dynamic torsion, abrasion) and biocompatibility tests are not specified in this summary.
• Data Provenance: The tests were likely conducted in a laboratory setting, as is typical for mechanical performance evaluation of orthopedic implants. No country of origin for "data" in the sense of clinical cases is applicable here, as it's a materials and mechanical performance study, not a clinical trial.

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

This is not applicable. The "ground truth" for mechanical testing is derived from established engineering standards and physical measurements, not expert consensus. For biocompatibility, it's evaluated against ISO standards or similar guidelines by toxicology or materials science experts.

4. Adjudication method for the test set:

This is not applicable. Mechanical and biocompatibility tests follow established protocols, and results are typically objective measurements.

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 is not applicable. This 510(k) is not for an AI device.

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

This is not applicable. This 510(k) is not for an AI device.

7. The type of ground truth used:

• Mechanical Performance: Ground truth is based on established engineering principles, material science, and comparison to the known performance of predicate devices.
• Biocompatibility: Ground truth is based on recognized biological safety standards for implantable materials.

8. The sample size for the training set:

This is not applicable. This 510(k) is not for an AI device, so there is no "training set."

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

This is not applicable. As above, no training set or medical image expert ground truth is relevant here.

In summary: The provided document is a 510(k) summary for a physical medical implant (a vertebral body replacement system), not for an AI/ML-driven device. Therefore, the requested information, which pertains to the evaluation framework of AI/ML technologies (e.g., sample sizes of test/training sets, expert readers, ground truth for image interpretation, MRMC studies), is not present and is not relevant to this specific premarket notification. The "study" described is a series of mechanical and biocompatibility tests for the device material and design, demonstrating equivalence to already cleared predicate devices.

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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 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 thoracolumbar 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 text describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one would expect for a novel AI/software as a medical device (SaMD).

Here's an analysis based on the information provided, highlighting what is present and what is not:

Acceptance Criteria and Device Performance Study (as per provided text)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implied as meeting or being equivalent to the predicate devices and applicable standards. Specific numerical thresholds for each test (e.g., "withstanding X N of static compression") are not provided in this summary.

2. Sample Size and Data Provenance for Test Set

• Sample Size (Test Set): Not explicitly stated. The documentation refers to "test data" and "performance testing" but does not specify the number of units or samples tested for each mechanical test.
• Data Provenance: Not explicitly stated. Given the nature of mechanical and biocompatibility testing for a physical implant, the data would typically be generated in laboratory settings. There is no indication of patient data (e.g., country of origin, retrospective/prospective) because this submission is not focused on clinical performance in patients but rather on mechanical and chemical properties.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable to this type of device submission. The ground truth for mechanical and biocompatibility testing is typically based on standardized testing procedures and material science principles, not expert consensus on interpretations of data like in diagnostic imaging.

4. Adjudication Method for Test Set

• Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for human interpretation tasks, especially in diagnostic studies, not for the direct measurement of mechanical properties or biocompatibility of an implant.

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

• Not applicable. This study type is used to evaluate the impact of AI on human reader performance for diagnostic tasks (e.g., imaging). The Trabecular Metal Vertebral Body Replacement System is a physical implant, not a diagnostic AI device.

6. Standalone Performance (Algorithm Only)

• Not applicable. This concept pertains to AI algorithms. The device is a physical implant, so there is no "algorithm only" performance to assess in this context.

7. Type of Ground Truth Used

• Mechanical Testing Results: The "ground truth" for the mechanical tests would be the measured physical properties (e.g., strength, durability) obtained through standardized engineering tests, compared against established performance benchmarks for predicate devices and relevant ASTM/ISO standards.
• Biocompatibility Data: The "ground truth" for biocompatibility would be the results of laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993 series standards, demonstrating that the material does not elicit an unacceptable biological response.

8. Sample Size for Training Set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which are not described here.

9. How Ground Truth for Training Set Was Established

• Not applicable. (See point 8).

Summary of what the document indicates for substantial equivalence:

The Zimmer TMT Trabecular Metal Vertebral Body Replacement System demonstrated substantial equivalence by showing that it performs equivalently to the cited predicate devices (K010378, K021025, K021967, K022563, K031823, and K032527) based on mechanical performance data and biocompatibility data. The mechanical tests included static compression, dynamic compression, static torsion, dynamic torsion, and abrasion. The conclusion was that the device will perform as intended and is equivalent to the predicate devices.

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