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When used as a vertebral body replacement, the TASMIN® R devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumaffracture. 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 TASMIN® R 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 I 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 TASMIN® R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. 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 TASMIN® R device is a spinal intervertebral body fixation orthosis and intervertebral body fusion device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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: The documentation refers to "worst case TETRIS™ and TASMIN® R devices" for finite element analysis and "worst case TASMIN® R devices" for physical testing. It does not specify the exact number of devices or scenarios considered. It is implied that representative "worst-case" configurations were selected for the evaluation.
• Data Provenance: The studies are described as "Finite element analysis simulations" and "Static and dynamic compression testing." This indicates the data was generated from engineering analyses and laboratory bench testing performed by the sponsor, SIGNUS Medizintechnik GmbH. The country of origin of the data is not explicitly stated, but the sponsor is based in Germany. The data is prospective in the sense that it was generated specifically for the premarket submission.

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

This information is not applicable as the studies performed were bench testing and finite element analysis, not clinical studies requiring expert consensus on patient data. The "ground truth" for these types of studies is established by adherence to recognized ASTM standards and engineering principles.

4. Adjudication Method for the Test Set

This information is not applicable for bench testing and finite element analysis. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of imaging or clinical outcomes.

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

An MRMC comparative effectiveness study was not conducted. The device is a medical implant, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was derived from:

• Recognized Industry Standards: ASTM F2077 (for compression, torsion, compression-shear) and ASTM F2267 (for subsidence properties). These standards define the methodology and expected performance for intervertebral body fusion devices.
• Engineering Principles: Finite element analysis relies on established biomechanical and engineering principles to simulate mechanical behavior.
• Material Specifications: ASTM F2026 for PEEK-OPTIMA® LT1 and ASTM F560 for Tantalum, defining the accepted properties of the materials.

8. The Sample Size for the Training Set

This information is not applicable. The studies performed were bench testing and simulations, not machine learning studies that require a training set.

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

This information is not applicable as there was no training set for a machine learning algorithm. The "ground truth" for the device's performance was established by adherence to ASTM standards and engineering principles as described in point 7.

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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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