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FIDJI type 5 is a vertebral body replacement device that is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to turnor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. This device is intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System. Additionally, FIDJI type 5 is intended to be used in a paired configuration.

The Spine Next FIDJI Vetebral Body Replacement Type 5 devices are hollow blocks that are machined from extruded Polyetheretherketone (PEEK); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

The provided text describes a 510(k) premarket notification for a medical device, the Spine Next FIDJI Vertebral Body Replacement Type 5. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with specific acceptance criteria as you might see for a PMA (Premarket Approval) application for a novel device.

Therefore, the information you're asking for regarding acceptance criteria, specific study details (sample sizes, experts, adjudication methods, MRMC studies, standalone performance), and ground truth establishment, is generally not applicable to a 510(k) submission like this one. 510(k)s focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering and performance testing that shows the new device performs similarly within established standards, rather than generating new clinical data against specific performance targets.

However, I can extract the relevant information from the provided text that aligns with what is typically done for a 510(k) in terms of "comparison to predicate" which serves as the "proof" of meeting the implicit acceptance criteria of substantial equivalence.

Acceptance Criteria and Device Performance (Implicit through Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a legally marketed predicate device. This is primarily done by showing similar technical characteristics, indications for use, and performance. When comparing to a predicate, the "performance" often refers to engineering and bench testing rather than clinical study outcomes.

Study Details Not Applicable to This 510(k) Submission

As this is a 510(k) submission, the device did not undergo a clinical study in the traditional sense that would generate new clinical performance data. Instead, it demonstrated equivalence to existing predicate devices based on design, materials, and mechanical performance testing (implied by "All devices meet mechanical performance requirements"). Therefore, the following information is not provided or required for this type of submission:

1. Sample size used for the test set and the data provenance: Not applicable for a 510(k) unless specific clinical data was used to demonstrate equivalence (which is not indicated here). The "test set" would primarily refer to engineering bench tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as clinical ground truth establishment is not typically part of a 510(k) for this type of implant.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not indicated and generally not a requirement for an orthopedic implant 510(k).
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for an orthopedic implant. Ground truth for performance would come from validated mechanical testing methodologies against industry standards or predicate device performance.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is the comparison to predicate devices, primarily focusing on technical characteristics, materials, and functional equivalence, often backed by bench testing to ensure mechanical performance is comparable. The FDA's decision to clear the device (K042713) signifies their acceptance that this comparison adequately demonstrates substantial equivalence to legally marketed predicate devices.

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FIDJI types 1, 2, 3, and 4 are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). The device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft and supplemental fixation, such as the Spinal Concepts, Inc. InCompass System.

The FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4 devices are hollow blocks that are machined from PEEK OPTIMA® (polyetheretherketone, ASTM F2026); the blocks are tapered to aid in maintaining lordosis of the spine following implantation. The devices have angled teeth on the cephalad and caudal surfaces. The devices include tantalum inserts that serve as a location and orientation markers for radiographs.

The provided text describes a 510(k) premarket notification for a medical device called "FIDJI Vertebral Body Replacement Types 1, 2, 3, and 4." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, intended use, and mechanical testing.

It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive system.

Therefore, I cannot provide the requested information in the format of the table and points because the document is not about an AI-powered device or a study involving human readers or ground truth for an AI system.

The document's "Mechanical Testing" section states: "Mechanical testing demonstrated that FIDJI types 1,2,3, and 4 exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine." This indicates that physical, laboratory-based testing was conducted to ensure the device's structural integrity and performance, which is typical for implantable medical devices. However, this is not related to the type of AI/algorithm study information you've requested (e.g., sample size for test/training set, expert consensus, MRMC studies).

Ask a specific question about this device