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The Curved PEEK Tetris™ Spinal Implant is 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.

The Curved PEEK Tetris ™ may be implanted singularly or in pairs.

The supplemental internal fixation systems that may be used with the Curved PEEK Tetris™ Spinal Implant is the same as the Curved PEEK Tetris™ Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The Curved PEEK Tetris® Spinal implant is a hollow, slightly curved frame with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.

The frame is forged from PEEK (PEEK-OPTIMA™ LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.

The Curved PEEK Tetris™ Spinal Implant is available in a variety of sizes ranging from 7mm to 48mm. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The Curved PEEK Tetris™ may be implanted individually or in pairs.

The provided text is a 510(k) summary for the Curved PEEK Tetris™ Spinal Implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through clinical trials or performance testing.

Therefore, the input does not contain information on acceptance criteria, a study that proves the device meets specific criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details.

The document primarily focuses on establishing substantial equivalence based on similarities in:

• Intended Use: Used to replace a vertebral body resected due to tumor or trauma/fracture in the thoracolumbar spine (T1 to L5), with supplemental internal fixation.
• Operating Principle: Not explicitly detailed beyond being a vertebral body replacement.
• Basic Design: Hollow, slightly curved frame with tapered edges, open upper and lower aspects, and walls featuring spikes for anchorage.
• Materials: PEEK (PEEK-OPTIMA™ LT1) with Titanium alloy (TiAl6V4) marker pins.
• Surgical Techniques and Equipment: Same as the predicate device.
• Supplemental Internal Fixation Systems: Same as the predicate device (e.g., DePuy AcroMed titanium plate or rod systems).
• Manufacturing Environment, Sterilization Process, and Packaging Configurations: Same as the predicate device.

Conclusion stated in the document: The Curved PEEK Tetris™ is substantially equivalent to the predicate device, PEEK Tetris™ (cleared under K031757), based on functional design, indication for use, principles of operation, materials, and performance characteristics.

Since the provided text does not contain the information requested in the prompt regarding acceptance criteria, studies, and data specific to performance validation, I cannot fill out the requested table or provide those details. The 510(k) process relies on demonstrating equivalence to an existing device, rather than providing new performance data against specific acceptance criteria for a novel device.

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The PEEK Tetris™ Spinal Implant is 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). The PEEK Tetris™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the PEEK Tetris™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The PEEK Tetris™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from PEEK which is radiolucent and incorporates Titanium alloy marker pins so the device can be located within the body. The PEEK Tetris™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition.

The provided text describes a 510(k) submission for the PEEK Tetris™ Spinal Implant and focuses on demonstrating its substantial equivalence to a predicate device, the Titanium Tetris™.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance results. Instead, it relies on demonstrating comparable functional and performance characteristics to the predicate device through testing. The key acceptance criterion is that the PEEK Tetris™ must perform equivalently or superiorly to the Titanium Tetris™ regarding its intended use as a vertebral body replacement.

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

The document states: "Representative samples of the device underwent testing to demonstrate comparable functional and performance characteristics to the predicate device."

• Sample Size: "Representative samples" implies a test set was used, but the exact number of devices or experimental units is not specified.
• Data Provenance: The document does not specify the country of origin for the data. It's safe to assume the testing was conducted in a controlled lab environment. It is a prospective study in the sense that the testing was performed specifically for this 510(k) submission.

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

This type of information is not applicable to this submission. The device is a physical medical implant, and its "performance" for regulatory purposes is evaluated through mechanical testing, material characterization, and comparison to a predicate device, not through expert assessment of clinical outcomes or images in a diagnostic context. Ground truth, in this context, would be established by direct physical measurements and material properties obtained from laboratory tests, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human observers (e.g., radiologists interpreting images) where conflicting interpretations need to be resolved. For mechanical testing of an implant, the results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or decision-support systems that influence human interpretation. The PEEK Tetris™ is a surgical implant and does not involve AI assistance or human readers in its direct use or regulatory evaluation for this 510(k).

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

This is not applicable. The PEEK Tetris™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for evaluating the PEEK Tetris™ (in comparison to the predicate) would be based on:

• Physical and Mechanical Testing: Direct measurements of properties like strength, stiffness, fatigue resistance, and geometric conformity.
• Material Characterization: Verification of the PEEK material composition and its properties.
• Biocompatibility Standards: Compliance with established biocompatibility standards, demonstrated by analogy to other legally marketed devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical implant. Training sets are relevant for machine learning algorithms.

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

This is not applicable for the same reason as point 8.

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The TETRIS™ Spinal Implant is 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).

The TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

The TETRIS™ Spinal Implant is a hollow, rectangular frame with lateral fenestrations. The upper and lower aspects of the implants are open and the walls feature spikes, which assist in the positive anchorage and seating of the implants between the superior and inferior vertebral bodies. The frame is forged from a titanium alloy (Ti6Al4V).

The TETRIS™ Spinal Implant is available in a variety of sizes and a wedge shaped option. This enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The TETRIS™ may be used individually or paired based on anatomy and amount of bone resected by the surgeon. When using two implants, care should be taken not to mix flat and wedged shaped devices.

The provided text describes a 510(k) premarket notification for a medical device called the TETRIS™ Spinal Implant. The information focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories are not applicable.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The study involved mechanical testing, not a clinical test set with human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This was mechanical testing, not an assessment requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

Not applicable. This submission concerns a physical medical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm. The device itself is a standalone implant.

7. The Type of Ground Truth Used

The ground truth used was based on mechanical engineering standards and validated testing protocols as outlined in the "Guidance for Spinal System 510(k)s."

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set. The device's design and manufacturing rely on established engineering principles and materials science.

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

Not applicable. As above, this is not an AI algorithm.

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