Search Results

The CRESCENT® Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The CRESCENT® Spinal System Titanium consists of a variety of hollow intervertebral body spacers featuring a bullet nosed, anatomically shaped design with axial voids designed to hold bone graft material. The subject devices are designed with diamond V teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The subject devices are manufactured from anodized medical grade titanium alloy (Ti-6Al-4V).

This document is a 510(k) summary for the CRESCENT® Spinal System Titanium, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to previously marketed devices through non-clinical testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of devices. The "tests" refer to engineering analyses (FEA) and mechanical testing (ASTM standards) of the device design and materials, not clinical patient data.
• Data Provenance: Not applicable in the context of clinical data. The data provenance is from engineering simulations and laboratory mechanical testing.

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

This information is not provided in the document. For mechanical testing or FEA, "ground truth" would typically be defined by engineering specifications and standards, and the work would be performed and verified by engineers with expertise in biomechanics, materials science, and computational modeling.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving expert review of patient data, which is not what this 510(k) summary describes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a medical device (spinal implant), which relies on non-clinical testing to demonstrate substantial equivalence, not clinical effectiveness studies comparing human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this device. This is a physical spinal implant, not an algorithm or AI system. Therefore, no standalone performance study in the sense of an algorithm's performance was conducted or is relevant.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on engineering specifications, established ASTM standards (F2077, F2267), and the performance characteristics of previously cleared predicate devices. The device's performance in FEA and supplemental testing was compared against these established benchmarks to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. This is not an AI/ML device, so there is no "training set" in that context. The device's design and material properties are developed through engineering processes, not machine learning training.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device