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The Rhausler RT2 Trabeculite Titanium Cervical Cage System is intended for spinal fusion procedures at one level (C3-T1) in skeletally mature patients with cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have at least 6 weeks of nonoperative treatment.

This device is intended to be used with supplemental spinal fixation systems.

The Rhausler RT2 Trabeculite Titanium Cervical Cage System is a cervical intervertebral body fusion device. The system is comprised of implants and instruments. The instruments are utilized for the implantation procedure. All implants are manufactured from medical grade Titanium alloy (Ti6 Al 4V).
The implant is rectangular in shape with lordotic configuration, i.e., with 4 degree profiles. It is offered in two cross sectional sizes and is available in various height options to accommodate variations in patient anatomy. The center of the implant has a hollow cylindrical shape fenestration for placement of autogenous bone. Trabeculite Titanium Cervical Cage implant is provided sterile.

This document is a 510(k) premarket notification for the RT2 Trabeculite Titanium Cervical Cage System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. It does not contain information about an AI/ML device or its performance study.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study for an AI/ML device, as this document pertains to a medical device (cervical cage) and its mechanical and biocompatibility testing, not an AI or algorithm.

If you have a document about an AI/ML medical device, please provide that, and I will be happy to extract the relevant information.

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Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile.

This document is a 510(k) premarket notification for the Rhausler Plage™ Anterior Cervical Fusion System, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets clinical performance acceptance criteria through a specific study with human subjects.

Therefore, many of the requested categories regarding clinical study design, sample sizes, expert ground truth, and AI performance metrics are not applicable to this type of submission. The performance testing here refers to mechanical testing, not clinical performance.

Here's a breakdown of the information that can be extracted or that is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Meets ASTM F2077 (static and dynamic compression and torsion) standards.	Mechanical testing performed per ASTM F2077 (static and dynamic compression and torsion). Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
   Meets ASTM F2267 (subsidence testing) standards.	Subsidence testing performed per ASTM F2267. Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
   Meets ASTM F1877 (wear testing) standards.	Wear testing performed per ASTM F1877. Results of performance testing are "substantially equivalent to the predicate devices." (No specific numerical results provided in this summary).
   Substantially equivalent in safety and effectiveness to predicate devices.	Performance test results confirm that design differences do not pose new issues of safety or effectiveness. Conclusion: "Based upon the design, technology, performance, and intended use, Rhausler Plage Anterior Cervical Fusion System is substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act."

2. Sample size used for the test set and the data provenance:

   • N/A. This document describes mechanical component testing, not a clinical study on a patient test set. The testing was done on the device components themselves.
   • The provenance is Rhausler Inc., located in San Carlos, CA, USA, where the device was developed and tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. No human experts were used to establish ground truth for this type of mechanical engineering test. The "ground truth" for mechanical testing is adherence to established ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. This is not a clinical study involving human assessment. The "adjudication" is based on whether the device's mechanical properties meet the specified ASTM standards and are comparable to predicate devices.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. This device is a physical implant, not an AI or imaging diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • N/A. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" in this context is adherence to recognized ASTM mechanical testing standards (F2077, F2267, F1877) and demonstrating substantial equivalence to existing predicate devices based on these mechanical properties.

8. The sample size for the training set:

   • N/A. This is not a machine learning or AI study, so there is no "training set." The mechanical tests are performed on a sample of the manufactured devices. The specific number of physical units tested is not provided in this summary, but would be detailed in the full test reports.

9. How the ground truth for the training set was established:

   • N/A. As there is no training set in the AI/ML sense, this question is not applicable.

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