Search Results

Intervertebral Body Fusion Device: The DeRoyal Spine Spacers are intended for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of non-operative treatment. The device is indicated for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the lumbar spine.

Vertebral Body Replacement Device: The DeRoyal Spine Spacer System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The device system is intended for use in the thoracolumbar spine from T1 to L5. The devices are intended for use with supplemental fixation and with autograft or allograft bone. The Spine Spacer System is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Device Description

The DeRoyal Spine Spacer System consists of PEEK cages having the basic shape of a structural column. The top and bottom surfaces feature teeth to engage the bony endplates. The implants include a large vertical cavity which is packed with bone graft material to promote fusion of the adjacent vertebral bodies. The implants are offered in a variety of heights, widths, lengths and lordotic angles to accommodate varying patient anatomy.

AI/ML Overview

The DeRoyal Spine Spacer System is a medical device and its performance is evaluated through mechanical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, ground truth types) are not applicable.

Here's an analysis of the provided text based on the nature of the device and its evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance	Comments
ASTM F2077 (Static and dynamic compression)	"Mechanical testing of the worst case Spine Spacer was performed according to ASTM F2077... The mechanical test results demonstrate that the Spine Spacer device performance is substantially equivalent to the predicate devices."	Specifically, compression testing (both static and dynamic) ensures the device can withstand the forces it will encounter in the spine without failing or deforming excessively.
ASTM F2077 (Static and dynamic torsion)	"Mechanical testing of the worst case Spine Spacer was performed according to ASTM F2077... The mechanical test results demonstrate that the Spine Spacer device performance is substantially equivalent to the predicate devices."	Torsion testing (both static and dynamic) assesses the device's ability to resist twisting forces, which are also present in spinal movements.
ASTM F2267 (Subsidence properties)	"The subsidence properties were evaluated according to ASTM F2267."	Subsidence testing determines how well the device resists sinking into the surrounding bone under load, which is critical for long-term stability and prevention of complications. The text implies the results met the standard's requirements, leading to substantial equivalence.
ASTM Draft Standard (29 August 2000) (Expulsion testing)	"Expulsion testing was performed according to the ASTM Draft Standard (29 August 2000)."	Expulsion testing ensures the device remains securely in place within the intervertebral space and does not migrate out due to forces such as coughing, straining, or spinal movement. The text implies the results met the standard's requirements, leading to substantial equivalence.
Substantial Equivalence to Predicate Devices	"The DeRoyal Spine Spacer System devices possess the same intended use and technological characteristics as the predicate devices. Therefore the DeRoyal Spine Spacer System is substantially equivalent for its intended use."	The overall acceptance criterion is demonstrating "substantial equivalence" to legally marketed predicate devices, meaning it is as safe and effective. The mechanical tests contribute to demonstrating this.

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

Sample Size: Not explicitly stated. For mechanical testing, devices are typically tested in batches to ensure consistency and statistical significance, but a specific number is not provided in this summary. It mentions "worst case Spine Spacer," implying representative samples.
Data Provenance: The mechanical testing was conducted by DeRoyal Industries, Inc. (the manufacturer) and presumably in a controlled laboratory environment. This is prospective testing of manufactured devices.
Country of Origin of the Data: United States (based on the sponsor's location and FDA submission).

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

Not Applicable. For mechanical testing of a medical implant, the "ground truth" is defined by established engineering standards (ASTM F2077, ASTM F2267, ASTM Draft Standard). There are no human experts "establishing ground truth" in the way one would for diagnostic imaging. The experts involved would be engineers and quality control personnel performing and interpreting the tests according to the standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints. Mechanical testing relies on objective measurements against predefined criteria and standards.

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

No. This is a mechanical device, not a diagnostic or AI-driven system that would involve human readers interpreting cases.

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

Not Applicable. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of AI does not apply.

7. The Type of Ground Truth Used

Engineering Standards and Predicate Device Performance. The "ground truth" for the DeRoyal Spine Spacer System's mechanical performance is defined by the requirements outlined in the specified ASTM standards (ASTM F2077, ASTM F2267, ASTM Draft Standard) and the performance characteristics of the legally marketed predicate devices that the DeRoyal system aims to be substantially equivalent to.

8. The Sample Size for the Training Set

Not Applicable. This device uses mechanical testing for performance evaluation, not machine learning, so there is no "training set."

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

Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Ask a Question

Ask a specific question about this device

Page 1 of 1