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The ARIX Rib System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.

The ARIX Rib System is composed locking bone plate and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. The ARIX Rib System is made of Unalloyed Titanium and Titanium Alloy (Ti-6Al-4V). The bone plates consist of straight type and curved type which has different lengths and number of plate holes. The bone screws are compatible with K181806 ARIX Sternal System Bone Screw previously cleared. The screws are 2.4 and 2.7mm in diameter with self-tapping and provided with lengths from 8.0 to 20.0mm.

This document describes the device as the ARIX Rib System, a metallic bone fixation appliance and accessory.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "No clinical studies were considered necessary and performed."
Therefore, there is no information regarding a test set, sample size, or data provenance from clinical trials. The evaluation was based solely on non-clinical (bench) testing.

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

Given the absence of clinical studies, there was no "test set" in the context of human data requiring expert ground truth establishment. The ground truth for the bench tests was the established performance specifications outlined in the ASTM standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No MRMC comparative effectiveness study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable to this device. The ARIX Rib System is a physical medical device (bone plates and screws), not an AI algorithm. Its "performance" is assessed through mechanical and material properties as per industry standards, not through algorithmic evaluations.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the ground truth was defined by the specifications and requirements outlined in the referenced ASTM standards:

• ASTM F382, Standard Specification and Test Method for Metallic Bone Plates
• ASTM F543, Standard Specification and Test Method for Metallic Medical Bone Screws

8. The Sample Size for the Training Set

Not applicable. The ARIX Rib System is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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The FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the FIX-C PEEK Anterior Cervical Interbody System should be packed with autogenous bone graft and implanted via an anterior approach. The FIX-C PEEK Anterior Cervical Interbody System is intended to be used with supplemental fixation.

The FIX-C PEEK Anterior Cervical Interbody System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The FIX-C PEEK Anterior Cervical Interbody System devices are designed for an anterior approach.

The provided document is a 510(k) summary for the "FIX-C PEEK Anterior Cervical Interbody System." This type of document is for a medical device that achieves FDA clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a process requiring a clinical study with detailed acceptance criteria for AI/ML performance.

Therefore, the requested information regarding acceptance criteria, study details involving AI/ML performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details is not applicable to this submission.

The document primarily focuses on demonstrating equivalence through:

1. Indications for Use: Stating the same intended use as the predicate device (FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease at one level from C2-T1).
2. Technological Characteristics Comparison: A table (on page 5) compares the subject device to the predicate device (K120275) showing "Equivalent" or "Similar" conclusions for parameters like design/shape, depth/width, height, bone graft contact area, materials (PEEK and Ti-6AL-4V ELI), sterilization, biocompatibility, and performance (based on ASTM standards for mechanical testing).

The "performance" mentioned in the document refers to mechanical and material performance testing (non-clinical verification), not to the performance of an AI/ML algorithm in image interpretation or diagnosis. Specifically, the performance criteria are based on recognized standards such as ASTM F2077 and ASTM F2267, which cover static and dynamic torsion, axial compression, compression shear testing, and subsidence testing of interbody fusion devices.

In summary, this document does not contain information about acceptance criteria or a study that proves an AI/ML device meets acceptance criteria because the device is a spinal implant, not an AI/ML diagnostic or assistive tool.

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