(113 days)
The standard and oblique Rampart One devices are integrated intervertebral body fusion devices 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 I 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 had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous bone graft.
The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.
The oblique Rampart One device must be used with supplemental fixation systems cleared by FDA for use in the lumbar spine.
Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.
Regarding the Rampart™ One Lumbar Interbody Fusion Device and its K180002 submission for expanded indications of use, the document states that no new performance or clinical testing was performed or required. Therefore, there are no specific new acceptance criteria or studies associated with this particular submission that prove new performance.
The document instead refers to previously conducted performance testing for the Rampart One device and a review of published clinical data for similar stand-alone devices.
Here's a breakdown based on the provided text, focusing on what is mentioned or not mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
Since new performance testing was not conducted for this specific submission, there isn't a table of new acceptance criteria and device performance. The document states that the initial performance testing for the Rampart One device remains valid. That initial testing established conformance to the following standards:
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| ASTM F2077 - Static and Dynamic Compression | Conformed |
| ASTM 2267 - Subsidence | Conformed |
| ASTM F543-13 - Axial Pullout | Conformed |
| Static and Dynamic Compression Shear | Conformed |
| Anti-Screw Backout | Conformed |
| Expulsion | Conformed |
| ANSI/AAMI FT-72:2011 - Bacterial Endotoxin Testing (BET) | Conformed |
Note: The specific quantitative performance metrics (e.g., specific load values, displacement limits) for "conformed" are not provided in this summary but would have been part of the original K163670 submission's testing report.
2. Sample Size Used for the Test Set and Data Provenance
- For Performance Testing: The sample sizes used for the initial performance testing (referenced but not detailed here) are not specified in this document. These would have been documented in the original K163670 submission.
- For Clinical Data (Review): The document mentions a "review of published clinical data," which implies data collected retrospectively or prospectively from various studies. No specific sample size or data provenance (e.g., country of origin) is given for this review, as it refers to a compilation of existing literature rather than a new, specific clinical study associated with this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission, as no new clinical test set was created or evaluated in a way that required an independent expert panel for ground truth establishment. The clinical evaluation relied on a review of existing published literature.
4. Adjudication Method for the Test Set
This information is not applicable, as no new clinical test set requiring adjudication was performed for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done for this submission. The submission states that "clinical testing was not required or performed to support substantial equivalence."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the device is a physical medical implant, not an algorithm or AI software, and therefore "standalone performance" in that context does not apply.
7. Type of Ground Truth Used
- For Performance Testing: The ground truth for the engineering performance tests (e.g., compression, pullout) is the physical properties and mechanical behavior of the device under specified testing conditions, as measured against the limits set by the ASTM standards.
- For Clinical Data Review: The "ground truth" for the clinical evaluation was derived from published clinical outcomes related to similar stand-alone anterior lumbar intervertebral body fusion devices with integrated fixation. This essentially means the consensus findings and results reported in established medical literature.
8. Sample Size for the Training Set
This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.
§ 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.