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The Trivergent Spinal Fixation System is intended to provide immobilization of a single spinal segment in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of lumbar and sacral spine from L2-S1: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; and failed previous fusion.

The Trivergent Spinal Fixation System is a pedicle screw system intended to stabilize and immobilize the L2-S1 spinal segments as an adjunct to fusion. The system includes a variety of screws and plates along with guides, guidewires, drills, drivers, handles, and tans.

The Trivergent Spinal Fixation System plates and screws are available in a variety of geometries to accommodate various patient anatomies. The Trivergent screws come in lengths from 45mm to 60mm, and the Trivergent plates come in angles from 60° to 75°.

The Trivergent Spinal Fixation System implants and instruments are provided non-sterile and are to be sterilized by the end user.

The Trivergent Spinal Fixation System implants are machined from Ti-6A1-4V ELI per ASTM F136.

This document describes the Trivergent Spinal Fixation System, a medical device. Based on the provided text, it's a 510(k) Premarket Notification for a Class II medical device, specifically a pedicle screw system. These submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results for novel AI-powered diagnostics.

Therefore, the information typically found in an AI/ML medical device submission (such as acceptance criteria for AI performance, clinical study design for AI efficacy, expert adjudication, etc.) is not present in this document. The "Performance Testing Summary" section focuses on bench testing of the physical device (e.g., static compression, fatigue testing) and a cadaver usability study, which are standard for orthopedic implants, not AI/ML algorithms.

Based on the provided text, I cannot answer the questions directly as they pertain to an AI/ML device's acceptance criteria and proving its performance.

Here's why and what information is available:

• Device Type: This is a physical orthopedic implant (spinal fixation system), not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: 510(k) demonstrates substantial equivalence, primarily through non-clinical (bench) testing and comparison to predicates, not typically extensive human clinical trials to establish efficacy akin to AI-driven diagnostics.
• Lack of AI/ML Specifics: There is no mention of algorithms, machine learning, image analysis, or any other AI-related components.

Therefore, the questions regarding acceptance criteria for AI performance, sample sizes for AI test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance simply do not apply to the content of this particular document.

If this document were for an AI/ML device, the required information would be detailed under sections like "Clinical Performance Data," "Software Validation," or "Algorithm Performance Benchmarks." This document is focused on the mechanical and material properties of a physical implant.

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