Search Results

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).

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (from "Functional and Safety Testing")	Reported Device Performance
Mechanical testing in accordance with "Guidance for Industry and FDA staff, Guidance for Spinal System 510(k)s"	"The results of the examination and testing were successful and did not raise any issues of safety and effectiveness of the device."

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.

Ask a Question

Ask a specific question about this device

Page 1 of 1