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The Opticage® Expandable Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage Expandable Interbody Fusion Devices are provided gamma sterilized and are for single use only. The devices are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. They are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM F136. Each device consists of five components: an upper and lower titanium plate, two titanium wedges and a central shaft. The faces of the upper and lower plates of the devices contain teeth and fenestrations to enhance bony in growth. The two titanium wedges are connected by the central shaft. The shaft can be rotated clockwise to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated counter clockwise to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted through a range of 5mm. A cavity internal to each device is intended to hold autogenous bone graft. The Opticage is available in a variety of configurations.

This appears to be a 510(k) summary for the Opticage® Expandable Interbody Fusion Device. Based on the provided text, the submission is a "special 510(k)" to obtain market clearance for additional models of the device, implying that the fundamental device design and efficacy have been previously established.

Therefore, the "acceptance criteria" and "study" described herein refers specifically to the new models' performance relative to the predicate device, rather than a de novo clinical trial demonstrating the primary safety and effectiveness of interbody fusion devices in general.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The text explicitly states: "Design verification testing was conducted via Finite Element Analysis (FEA) to assess the device modification."

• Sample Size for the Test Set: This refers to the number of simulations/analyses performed in the FEA. The document does not specify a numerical sample size for the FEA. It implies a single, comprehensive FEA study comparing the modified designs to the predicate.
• Data Provenance: This is not applicable in the traditional sense of patient data. The "data" here are the computational results from the Finite Element Analysis. As this is a simulation, there is no "country of origin" or "retrospective/prospective" aspect beyond the origin of the device manufacturer and the analysis itself.

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

Not applicable. The "ground truth" for the performance of the modified device, in this context, is established through the engineering principles and computational models used in the Finite Element Analysis, and then compared to the known performance of the predicate device. There is no mention of experts establishing a ground truth in the context of interpreting patient data or clinical outcomes for this specific submission.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication. The assessment of substantial equivalence relies on the analytical results of the FEA.

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

No, an MRMC comparative effectiveness study was not done. This submission is for additional models of an implantable medical device, and the performance assessment was conducted via Finite Element Analysis, not clinical (human reader) studies.

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

This question is typically relevant for AI/software as a medical device. For this implantable device, the closest equivalent is the Finite Element Analysis (FEA), which is a standalone computational simulation of the device's mechanical performance without human-in-the-loop interaction in the performance assessment itself. The analysis determines the mechanical properties of the device.

7. The Type of Ground Truth Used

The ground truth for this special 510(k) submission is the mechanical performance of the legally marketed predicate device (K152156). The FEA of the modified device is compared to this established performance to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning model. The "training" for the Finite Element Analysis (if one were to use that analogy) would be the development and validation of the FEA model itself, which is a complex engineering task and not typically described in terms of a "training set sample size" in this context.

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

Not applicable. As above, this is not a machine learning context. The FEA models are developed based on established engineering principles, material properties (e.g., Ti-6Al-4V per ASTM F136), and validated against physical testing methods, but the document does not detail this specific validation process for the FEA model used.

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