(42 days)
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.
| Acceptance Criteria (for Substantial Equivalence to Predicate) | Reported Device Performance/Assessment (for 18mm and 22mm Rampart™-L) |
|---|---|
| Same or equivalent: Intended Use | Same Intended Use as predicate device |
| Same or equivalent: Indications for Use | Same Indications for Use as predicate device |
| Same or equivalent: Fundamental Scientific Technology | Same Fundamental Scientific Technology as predicate device |
| Same or equivalent: Principle of Operation | Same Principle of Operation as predicate device |
| Same or equivalent: Device Design | Same Device Design as predicate device |
| Same or equivalent: Materials of Construction | Same Materials of Construction as predicate device |
| Same or equivalent: Lengths | Same Lengths as predicate device |
| Same or equivalent: Heights | Same Heights as predicate device |
| Not a new worst-case device configuration compared to predicate | Spineology confirmed subject devices do not represent a new worst-case device configuration. |
| Predicate performance data and risk mitigation measures support safe and effective use. | Assessment confirmed predicate data and risk mitigation support safe and effective use of 18mm and 22mm devices. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.