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When used as an Intervertebral Body Fusion System:

The Eclipse Vertebral Spacer System-Lumbar is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with accompanying radicular symptoms at one disc level from L2-S1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Lumbar implants are to be used with autogenous bone graft. Supplemental fixation is required.

When used as a Vertebral Body Replacement Device:

The Eclipse Vertebral Spacer System-Lumbar when used as a vertebral body replacement is intended for use for partial and total replacement of a vertebral body that has been resected or excised due to tumor and/or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine at a single level from TI-L5. These devices are intended to be used with autogenous bone graft. Supplemental fixation is required.

The Eclipse Vertebral Spacer-Lumbar acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. The device contains serrations on the superior and inferior surfaces and includes positioning pins that are advanced during placement. Pins are used to aid in the positioning and to allow for radiographic confirmation during device placement.

This document describes a 510(k) premarket notification for the "Eclipse Vertebral Spacer-Lumbar," an intervertebral body fusion device and vertebral body replacement device. This summary focuses on the safety and effectiveness studies, which are primarily non-clinical bench tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of Acceptance Criteria: The document explicitly states that "Test results for each of the above studies confirm that the Eclipse Vertebral Spacer is substantially equivalent to the predicate devices." For a 510(k) submission, "substantial equivalence" means the new device is as safe and effective as a legally marketed predicate device. Therefore, the implied acceptance criteria for each test is that the Eclipse Vertebral Spacer's performance must not be significantly different from, and ideally match or exceed, the performance of the identified predicate devices in these specific mechanical and material tests. The guidance document "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (FDA, June 12, 2007) would provide the specific test parameters and potentially quantitative acceptance ranges for such devices, against which the predicate and new device would be compared.

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

• Sample Size for Test Set: Not specified, as this refers to the number of physical device units tested in the non-clinical bench studies.
• Data Provenance: The studies are non-clinical bench tests. The document does not specify the location where these tests were conducted, nor if they were retrospective or prospective, as these terms are generally not applicable to bench testing.

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

• Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM standards) and objective physical measurements. Expert consensus in a medical context (like for image interpretation) is not relevant here.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or when reviewing medical images. This document describes mechanical bench testing only.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (intervertebral spacer), not an AI/software device that assists human readers.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

• Mechanical and Material Properties: The ground truth for these non-clinical tests is based on the established mechanical and material properties of the predicate devices and the requirements outlined in the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." This involves objective measurements of static and dynamic compression, shear forces, subsidence, and wear debris analysis.

8. The Sample Size for the Training Set:

• Not applicable. This submission describes non-clinical bench testing for a physical implant. There is no "training set" in the context of machine learning or AI algorithm development.

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

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