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When used as an intervertebral body fusion device, the Zuma System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

When used as a Vertebral Body Replacement Device, the Zuma System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, Zuma is intended for use with bone graft.

Zuma is an implantable spinal device made from polyetheretherketone (PEEK) and titanium with markers for radiographic visualization; it is secured to vertebral bodies with bone screws. The device has an open central area for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.

The provided text describes the 510(k) summary for the Zuma™ Interbody Fusion Device/Vertebral Body Replacement Device. It indicates that the device was deemed substantially equivalent to predicate devices based on comparisons in intended use, design, materials, and function. The only performance data mentioned is related to mechanical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The performance data mentioned is mechanical testing.

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

• Not Applicable. The submission states "Clinical data was not required for this device," and the performance data provided is mechanical testing, which typically does not involve expert ground truth for a test set in the same way clinical studies do.

4. Adjudication Method for the Test Set

• Not Applicable. As no clinical test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. A MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical data was not required for this device."

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

• Not Applicable. This device is a physical medical implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance mentioned is related to its mechanical properties.

7. The Type of Ground Truth Used

• The ground truth for the mechanical performance testing would be established by engineering standards and specifications for interbody fusion devices and vertebral body replacement devices. These standards define the acceptable mechanical properties (e.g., strength, stiffness, fatigue life) that the device must meet for its intended use.

8. The Sample Size for the Training Set

• Not Applicable/Not provided. This information is typically relevant for AI/ML models. For a physical medical device, there isn't a "training set" in the same sense. The device design and materials are developed based on engineering principles and preclinical testing, but a "training set" is not a concept explicitly applied here.

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

• Not Applicable/Not provided. Similar to point 8, this concept does not directly apply to the development of a physical medical device. The "ground truth" for the device's design and materials would be founded on established biomechanical and materials science principles, industry standards, and requirements for spinal implants.

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