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When used as an intervertebral body fusion device, the SeaSpine Spacer 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 autogenous bone graft and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer 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 SeaSpine Spacer 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, the SeaSpine Spacer System is intended for use with bone graft.

The SeaSpine Spacer System is a family of implantable devices (Hollywood™, Pacifica™, Redondo™/Redondo-L™, Ventura™) manufactured from polyetheretherketone (PEEK) and tantalum radiographic markers. The device has a central canal(s) for receiving bone graft and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.

The Redondoᵀᴹ/Redondo-Lᵀᴹ device by SeaSpine, Inc. is a vertebral body replacement device (VBR) and an interbody fusion device (spacer). The company claims that the Redondo-Lᵀᴹ device is substantially equivalent to existing predicate devices. The study conducted to demonstrate this equivalence focused on comparing the new cage geometry and design modifications of the Redondo-Lᵀᴹ to the predicate device.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

This study is not a clinical trial with human subjects. Instead, it is an engineering and clinical rationale verification study comparing the physical and design characteristics of a new medical device to a predicate device. Therefore, the concept of a "test set" in the context of patient data, sample size, or data provenance (country of origin, retrospective/prospective) as typically applied to AI/diagnostic studies is not applicable. The data provenance would be internal engineering and design specifications.

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

There is no mention of external "experts" establishing ground truth in the traditional sense of clinical interpretations. The "ground truth" for the acceptance criteria appears to be based on engineering standards and clinical rationale supported by existing medical knowledge regarding vertebral body dimensions, bone stress, and implant stability. This would likely involve internal engineering and clinical teams at SeaSpine, Inc. No specific number or qualifications of experts are provided, as this is an internal design control validation.

4. Adjudication Method for the Test Set

This study does not involve multiple human readers or a clinical test set that would require an adjudication method like 2+1 or 3+1. The verification was based on direct comparison of design characteristics against defined engineering and clinical rationale acceptance criteria.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted. This is a premarket notification (510(k)) for a physical medical device (vertebral body replacement) involving engineering and design comparisons, not an AI or diagnostic tool that would involve human readers interpreting images.

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

A standalone performance study for an algorithm was not done. This device is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used in this context is based on engineering specifications, established biomechanical principles, and clinical rationale for spinal implants. This includes comparative measurements (cross-sectional area, A/H ratio, wall thickness), considerations for anatomical fit (vertebral body dimensions), and functional performance (fixation, sublaxation).

8. The Sample Size for the Training Set

Since this is an engineering and design comparison for a physical medical device, not a machine learning model, the concept of a "training set" is not applicable.

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

As there is no training set in this context, the method for establishing its ground truth is not applicable.

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