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The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 6 months of non-operative treatment. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.

The SOVEREIGN® Spinal System consists of interbody cages, screws, coverplates, instruments, and accessories. The subject instruments include:
• Trial Handle
• Trials
• Coverplate Inserter
• Interbody Inserters

This document, a 510(k) Pre-market Notification for the SOVEREIGN® Spinal System, focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting primary clinical study data for acceptance criteria. As such, it does not contain the detailed information typically found in studies designed to prove a device meets specific performance acceptance criteria related to diagnostic or treatment efficacy.

Therefore, many of the requested details, such as the specific acceptance criteria for device performance in terms of clinical outcomes, sample sizes for test and training sets, expert qualifications, ground truth methods, and results of comparative effectiveness studies (MRMC or standalone AI performance), are not present in this regulatory submission.

This submission primarily relies on:

1. Comparison of Technological Characteristics: It argues that the new device is substantially equivalent to existing predicate devices based on design, materials, sterilization, intended use, indications, and surgical technique.
2. Performance Data (Validation and Mechanical Testing): It states that a pre-clinical validation study demonstrated the proposed instruments could be used as intended, and mechanical testing was performed in accordance with FDA guidance to support substantial equivalence. It explicitly states that "testing is not warranted for the subject instruments as they do not present a new worst case when compared to the predicate instruments".

Given this context, here is a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" for clinical performance are not explicitly defined in the provided text, as the focus is on substantial equivalence to predicate devices through technical and manufacturing aspects. The "performance" reported is primarily related to the mechanical and functional aspects of the hardware, not clinical outcomes in human subjects.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "pre-clinical validation study" was conducted in "spine models," which suggests bench testing or cadaveric testing, not a clinical test set from human data.
• Data Provenance: The nature of "spine models" doesn't allow for country of origin or retrospective/prospective classification in the typical sense of clinical data. It refers to laboratory or simulation environments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As the "test set" was in "spine models" for pre-clinical validation and mechanical testing, there would be no ground truth established by medical experts in the way it is done for clinical diagnostic or treatment studies. The "ground truth" for mechanical testing would be engineering specifications and successful functional operation within the models.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among experts on clinical ground truth. For mechanical and pre-clinical validation studies, conformity to specifications and successful operation are typically assessed by engineers and technicians.

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

Not applicable. This is a spinal implant system (intervertebral body fusion device and associated instruments), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or performed for this type of device.

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

Not applicable. This is a physical medical device (spinal implant system) and its instruments, not an algorithm or AI product.

7. The type of ground truth used

For the pre-clinical validation and mechanical testing, the "ground truth" would be:

• Engineering Specifications: Adherence to design parameters, material properties, and dimensional tolerances.
• Functional Success in Spine Models: The ability of instruments to perform their intended surgical steps without failure or deviation.
• Compliance with Standards: Verification that mechanical properties meet or exceed requirements outlined in relevant FDA guidance (e.g., "Guidance for Industry and FDA Staff – Spinal System 510(k)'s").

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "design predicate" information refers to existing devices that serve as comparators for substantial equivalence, not a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as no training set for an algorithm was used.

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