(104 days)
Rampart A 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 treatment.
Rampart A 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 A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are 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.
The provided text is a 510(k) summary for the Rampart A Lumbar Interbody Fusion Device. This document is a regulatory submission to the FDA for a medical device and does not describe a study involving an AI or an algorithm.
Therefore, I cannot provide information on acceptance criteria or studies proving device performance related to AI/algorithm performance. The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical implant (an intervertebral body fusion device).
Here's an analysis based on the information available in the provided text, specifically highlighting why the requested AI/algorithm-related information cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (for the physical device): The document doesn't explicitly list numerical acceptance criteria in a table format for this specific submission beyond demonstrating substantial equivalence. The "performance" assessment is based on comparison to predicate devices, focusing on intended use, technological characteristics, materials, sterilization, packaging, and operating principle.
- Reported Device Performance (for the physical device): The document states "No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device." This indicates that the performance was demonstrated through an engineering rationale and FEA comparing it to performance data of previously cleared, substantially equivalent predicate devices, rather than new, explicit performance metrics for Rampart A itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is not an AI/algorithm study. The "test set" here refers to the engineering analysis and comparison to predicate device data, not a clinical data set for an algorithm.
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)
- Not applicable as this is not an AI/algorithm study. Ground truth in the context of an interbody fusion device would be related to clinical outcomes, which are not detailed in this 510(k) summary as no de novo clinical study was performed. The "ground truth" for the engineering rationale would be established engineering principles and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/algorithm study.
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 as this is not an AI/algorithm study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/algorithm study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the engineering rationale, the "ground truth" would be established engineering principles and the performance data of the predicate devices as per ASTM F2077. For the device's clinical efficacy, it's based on the established safety and effectiveness of substantially equivalent predicate devices for the specified indications for use (L2 to S1 in patients with degenerative disc disease with up to Grade 1 spondylolisthesis).
8. The sample size for the training set
- Not applicable as this is not an AI/algorithm study.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/algorithm study.
In summary, the provided document is a regulatory submission for a physical medical device. It does not contain information about acceptance criteria or studies related to AI or algorithms.
§ 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.