(29 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 have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of carcellous and/or corticocancellous 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 two (2) screws and 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.
This document, K191091, is a 510(k) premarket notification for the Rampart™ One Lumbar Interbody Fusion System, specifically concerning the addition of a new Implant Inserter and modified Inserter Guides. It asserts substantial equivalence to a predicate device.
Crucially, this submission does not describe an AI/ML-driven device or diagnostic software that would typically have acceptance criteria related to classification metrics (e.g., sensitivity, specificity, AUC). Instead, it pertains to a physical medical device (intervertebral body fusion system) and its associated surgical instruments. The "acceptance criteria" and "study" described in the document are engineering and non-clinical performance tests for these physical instruments, not clinical performance metrics for an AI algorithm.
Therefore, many of the requested items in the prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission.
However, I can extract the relevant "acceptance criteria" and "proof" as described for this mechanical device:
Acceptance Criteria and Study for the Rampart™ One Lumbar Interbody Fusion System (Focus on Inserter and Guides)
Device Under Review: New Implant Inserter and modified Inserter Guides for the Rampart™ One Lumbar Interbody Fusion System.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering Focus):
| Acceptance Criterion (Implicitly "Met" or Verified) | Reported Device Performance/Confirmation |
|---|---|
| Functional Performance: The new Implant Inserter and modified Inserter Guides must properly function for the intended purpose of implanting the Rampart One Lumbar Interbody Fusion Device. | Design verification testing was conducted to "confirming function and performance in simulated use." (See section E. Non-Clinical Testing) |
| Interface Compatibility: The new Inserter and Guides must correctly interface with the existing Rampart One Implant. | "The instrument interface with the Rampart One Implant remains unchanged." (See section E. Non-Clinical Testing) |
| No Alteration to Intended Use: The modifications should not change the fundamental intended use of the instruments. | "A review of the design changes was performed and confirmed that these modifications do not alter the intended use of the instruments..." (See section E. Non-Clinical Testing) |
| No New Technological Characteristics: The modifications should not introduce new technological characteristics. | "...or present new technological characteristics." (See section E. Non-Clinical Testing) |
| No Alteration to Primary Control Mechanism/Operating Principle: The modifications should not change how the instruments are controlled or operate. | "The design changes do not alter the primary control mechanism or operating principle of the instruments." (See section E. Non-Clinical Testing) |
| Risk Profile Consistency: The modifications should not introduce new risks or alter the existing risk profile. | "A risk assessment was performed and confirmed that the modifications to the instruments do not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device." (See section E. Non-Clinical Testing) |
| Substantial Equivalence: The modified components, in conjunction with the system, must be substantially equivalent to the predicate device. | "Based on the intended use, technological characteristics, and comparison to the predicate device, Spineology has demonstrated that the new Rampart One Implant Inserter and modified Inserter Guides have been shown to be substantially equivalent to the legally marketed predicate device." (See section F. Conclusion) |
2. Sample size used for the test set and the data provenance:
- Not Applicable in the context of clinical AI/ML studies. This submission refers to "design verification testing" and "simulated use" for physical instruments. The sample size would refer to the number of tests/cycles performed on the instruments, which is not detailed in this summary.
- Data Provenance: Not specified as clinical data. It refers to internal engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the AI/ML sense, is not relevant here. The "ground truth" for a mechanical device is simply its physical performance against engineering specifications, likely established by internal engineers and quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are for human interpretation of clinical data, not for engineering tests of physical instruments.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the AI/ML sense. The "ground truth" is the engineering specifications and functional requirements of the device's mechanical performance.
8. The sample size for the training set:
- Not Applicable. No training set for an AI/ML model is involved.
9. How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/ML model is involved.
Summary of the Study Proving Acceptance (for this specific device and its modifications):
The "study" cited in this 510(k) summary is comprised of non-clinical engineering design verification tests and a risk assessment.
- Methodology: The submission states "Design verification testing was conducted to support the new Implant Inserter and modified Inserter Guides confirming function and performance in simulated use." This would typically involve mechanical tests, durability tests, dimensional checks, and functional tests to ensure the instruments properly hold, insert, and release the interbody fusion device.
- Proof: The success of these tests, combined with a review of design changes and a risk assessment, led the manufacturer (Spineology) to conclude that the modified components maintained the same intended use, technological characteristics, principle of operation, and risk profile as the predicate device. This forms the basis for their claim of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission of this type. The FDA's clearance letter indicates their agreement with this conclusion.
§ 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.