(69 days)
Rampar™ 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 I spondyolisthesis 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 of non-operative treatment. 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.
RampartTM L devices are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK-OPTIMA LT-1 with tantalum markers. The device is provided sterile and associated instruments are provided non-sterile.
This is a 510(k) premarket notification for a medical device (RampartTM-L, an intervertebral body fusion device). 510(k) submissions typically demonstrate substantial equivalence to a predicate device through non-clinical performance data and do not generally involve clinical studies with human participants, expert consensus for ground truth, or multi-reader multi-case studies as would be found for AI/ML-based diagnostic devices.
Therefore, many of the requested categories are not applicable to this type of submission.
Here's an analysis based on the provided text, focusing on the information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (RampartTM-L) |
|---|---|
| Similar static compression performance to predicate devices (Spineology PEEK Lumbar Interbody Fusion Devices/Rampart™-O) | Demonstrated similar static compression performance to identified predicate devices. |
| Similar static shear compression performance to predicate devices | Demonstrated similar static shear compression performance to identified predicate devices. |
| Similar subsidence performance to predicate devices | Demonstrated similar subsidence performance to identified predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The testing was preclinical (bench testing) and involved devices, not patient data.
- Data Provenance: Not applicable. The data is from bench testing, not clinical studies involving patients or human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable. Ground truth as typically defined in AI/ML studies is not relevant here, as this is preclinical mechanical testing.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is preclinical mechanical testing, not a study requiring adjudication of human observations.
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
- MRMC Study: No. This is not an AI/ML diagnostic device, and no MRMC study was conducted.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical intervertebral body fusion device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the mechanical testing, the "ground truth" (or reference) was the established performance characteristics of the predicate devices as measured by standardized ASTM F2077 and ASTM F2267 test methods. The goal was to show similar performance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no training set for this type of device.
§ 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.