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When used as a vertebral body replacement, the TETRIS™ II devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as an intervertebral fusion device, the TETRIS™ II devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the TETRIS™ II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

The information provided in the document describes the TETRIS™ II devices, which are spinal vertebral body replacement and intervertebral fusion devices. The FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting.

Instead, the performance data provided is related to bench testing and finite element analysis (FEA), which compares the new device to its predicates.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for TETRIS™ II Devices

The primary acceptance criteria for the TETRIS™ II devices in this submission hinge on demonstrating that their technological characteristics and mechanical performance are equivalent to predicate devices, ensuring they are "as safe and as effective."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: This notification does not detail a clinical test set with human or animal subjects. The "test set" in this context refers to the simulated models used in the finite element analysis. The specific number of models or simulations is not provided, but it states "Finite element analysis simulations of the worst case TETRIS™ and TETRIS™ II devices were compared."
• Data Provenance: The data provenance is from finite element analysis (FEA) simulations, which are computational models. It is not clinical data, and thus concepts like "country of origin" or "retrospective/prospective" don't apply in the traditional sense.

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

• Number of Experts: Not applicable. The "ground truth" for the FEA simulations is based on engineering principles, material properties (ASTM F136 for Ti-6Al-4V, ASTM F2026 for PEEK-OPTIMA® LT1, ASTM F560 for Tantalum), and the defined ASTM F2077 standards for mechanical testing of spinal implants. There's no indication of human experts establishing a ground truth in a diagnostic or clinical sense for these engineering simulations.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As this involves engineering simulations and comparison to established ASTM standards, a human adjudication method (like 2+1, 3+1 consensus) is not relevant. The outcome is determined by adherence to engineering analysis principles and the resulting numerical data.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission relies on engineering bench testing and FEA, not human reader studies of clinical cases.

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

• Standalone Performance: Not applicable in the context of an algorithm or AI. The "performance" assessment refers to the mechanical integrity and equivalence of the physical device design via FEA.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on established engineering standards and material properties. Specifically, the mechanical performance is evaluated against the requirements set forth in ASTM F2077 (Standard Test Methods for Static, Dynamic, and Torsional Axial Compression, Distraction, and Shear Testing of Spinal Arthrodesis Implants) and the material specifications of ASTM F136, ASTM F2026, and ASTM F560. The "ground truth" is that the device, when subjected to these simulated load conditions, performs comparably to the predicate devices and does not create a new "worst case."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This submission does not involve machine learning or AI, so there is no "training set." The FEA models are built based on geometries and material properties, not trained on data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set.

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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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