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Rampart™ L is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative studies. Rampart™-L is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Rampart™-L is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. The device is made of PEEK-OPTIMA LT1 with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.

Based on the provided document, the device in question is the Rampart™ L Lumbar Interbody Fusion Device. This document is a 510(k) premarket notification letter from the FDA, evaluating the substantial equivalence of new sizes (18mm and 22mm wide) of the device to an already cleared predicate device (12mm wide Rampart™-L).

Therefore, the document does not describe a study proving a new device meets acceptance criteria through performance evaluation. Instead, it describes how new sizes of an existing device are determined to be substantially equivalent to a previously cleared device. This means that extensive performance studies (such as those involving AI or human reader improvement, which are typical for new medical software or diagnostic devices) were not performed for this submission, as the core technology and function remain the same.

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

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the sense of performance metrics for a new device's function (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria for this submission are based on demonstrating substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not applicable. This submission is for new sizes of an existing device, and "new performance testing was not performed." The assessment relied on comparison to the predicate device's existing performance data and design characteristics.
• Data Provenance: Not applicable in the context of new performance data. The document refers to "Review of predicate performance data" and "Review of predicate risks and risk mitigation measures," implying the data originates from the studies previously conducted for the 12mm Rampart™-L predicate device. The provenance of that original data (country, retrospective/prospective) is not disclosed in this document.

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

Not applicable. No new test set requiring expert ground truth establishment was created for this submission. The evaluation was based on demonstrating design and functional equivalence to a predicate, relying on pre-existing data for the predicate.

4. Adjudication method for the test set

Not applicable. There was no new test set requiring adjudication.

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 device is an implanted medical device (intervertebral body fusion device), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.

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

Not applicable. This refers to an algorithm's performance, which is not relevant for an intervertebral body fusion device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable for this submission. The "ground truth" for the substantial equivalence determination relied on the physical and functional characteristics of the devices and reference to the established safety and effectiveness of the predicate. For the predicate device, it would have relied on mechanical testing, biocompatibility, and potentially clinical outcomes data, but this document does not detail those.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

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