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The LDR Spine ROI-C Titanium-Coated Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc 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 nonoperative treatment. The ROI-C Implants are to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.

The ROI-C Titanium-Coated Implant System consists of 'D' shaped blocks in two profiles, anatomic and lordotic, a variety of footprints within each profile, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat portion of the 'D' shape represents the anterior most portion of the device and includes features for attachment to instrumentation for insertion and slots for VerteBRIDGE® integrated fixation anchoring plates. The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) are coated with plasma-sprayed commercially pure titanium on the inferior and superior surfaces and feature two slots which allow for use with specially designed (and optional) supplemental fixation described below. The ROI-C Titanium-Coated Implant also features a tantalum radiographic marker on the posterior edge of the device. The VerteBRIDGE Anchoring Plates are made of titanium alloy (TiAl6V4) and can be inserted to obtain fixation to the vertebral bone and create a standalone cervical interbody fusion cage construct. The VerteBRIDGE Anchoring Plate used with ROI-C is curved, allowing it to be inserted into the ROI-C device in-line with the cage and then seated into the superior and inferior vertebral endplates. The ROI-C VerteBRIDGE Anchoring Plates are provided in two sizes: an 8mm length plate (intended for use with ROI-C devices height 4.5mm – 7mm) and a 9.5mm length plate (intended for use with ROI-C devices height 8mm -10mm). The anchoring plate locks into the ROI-C cage and provides stability to the construct via incorporated antiback out tabs and a central retaining ridge.

The provided document is a 510(k) premarket notification for the LDR Spine ROI-C Titanium-Coated Implant System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data (bench testing), rather than clinical studies proving efficacy in a human population. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria in the context of clinical performance, ground truth, expert consensus, or AI/human reader studies.

Here's what the document does provide regarding performance and testing:

Non-Clinical Performance Data: The document details the non-clinical (bench) testing performed to support substantial equivalence. These tests are conducted to ensure the physical and mechanical properties of the device are adequate for its intended use and comparable to predicate devices.

1. A table of acceptance criteria and the reported device performance:
The document does not provide a table specifying quantifiable acceptance criteria and reported device performance values for the non-clinical tests. It only lists the types of tests performed. To report this, I would need access to the detailed test reports that accompanied the 510(k) submission.

• Acceptance Criteria (Example for a fictional scenario): For Static Compression Testing, acceptance criteria might be "device must withstand X Newtons of force without permanent deformation or failure."
• Reported Device Performance (Example for a fictional scenario): For Static Compression Testing, reported performance might be "device withstood Y Newtons of force, exceeding the acceptance criteria."

2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for the non-clinical bench tests. The data provenance is "Non-clinical performance bench testing" conducted by the manufacturer, LDR Spine USA. These are laboratory tests, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. Non-clinical bench testing does not involve human subjects or expert consensus for ground truth on clinical outcomes. The "ground truth" for these tests would be the established engineering standards (e.g., ASTM standards) and the physical properties observed in the laboratory.

4. Adjudication method for the test set:
This information is not applicable to non-clinical bench testing. Adjudication methods are typically used in clinical studies involving human interpretation or outcome assessment.

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:
This information is not applicable. The device is an intervertebral body fusion implant, not an AI software/diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established engineering standards like ASTM F2077-11 for mechanical testing, and the observed physical properties of the materials and device. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of non-clinical bench testing for a surgical implant. Training sets are relevant for machine learning algorithms.

9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.

Summary of available information from the document:

• Device: ROI-C Titanium-Coated Implant System (intervertebral body fusion device)
• Indication: Degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1) in skeletally mature patients.
• Purpose of Submission: To extend the line of currently available ROI-C cages to include cages that incorporate a titanium coating.
• Performance Data Provided: Non-clinical (bench) testing only.
  • Static and dynamic compression testing per ASTM F2077-11
  • Static and dynamic compressive shear testing per ASTM F2077-11
  • Static and dynamic torsion testing per ASTM F2077-11
  • Subsidence testing and engineering analysis
  • Static cage expulsion testing
  • Static anchoring plate expulsion testing
  • Wear testing & debris analysis
  • Coating characterization
  • MRI compatibility testing
• Conclusion of Non-Clinical Testing: "The results of this non-clinical testing demonstrate that the strength and performance of the ROI-C Titanium-Coated Implant System are sufficient for its intended use and the device is therefore substantially equivalent to legally marketed predicate devices."
• Clinical Performance Data: "Clinical testing was not required to demonstrate substantial equivalence."

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