(173 days)
The Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The Omega LIF System is an intervertebral body fusion device. The subject and predicate lumbar devices are straight, bullet-nosed interbody devices designed to contain graft material and facilitate fusion between two vertebral bodies in the lumbar region of the spine.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device efficacy based on the provided text. The document is a 510(k) summary for a medical device (Omega LIF System), which focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy through acceptance criteria and detailed study results.
Here's why I cannot provide the requested information:
- 510(k) vs. Clinical Efficacy Studies: A 510(k) submission primarily aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety and effectiveness. It does not typically require extensive clinical trials or the establishment of detailed acceptance criteria for performance in the way a Pre-Market Approval (PMA) would.
- Lack of Specific Acceptance Criteria: The document mentions "non-clinical mechanical testing" and specific ASTM standards (F2077) for static/dynamic axial compression and compression shear, as well as subsidence, expulsion, and wear testing. However, it does not provide numerical acceptance criteria (e.g., "device must withstand X Newtons of force" or "subsidence must be less than Y mm"). It only states that the "Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device."
- No Clinical Study Details: There are no details about a clinical study involving human subjects that assesses the device's performance against pre-defined acceptance criteria for clinical outcomes. The document explicitly states the device is for intervertebral body spinal fusion procedures. While this implies clinical outcomes, the 510(k) summary itself does not contain the study to demonstrate those outcomes.
- No Information on AI/Algorithm Performance: Your request includes questions about AI performance, multi-reader multi-case studies, standalone algorithm performance, and training/test set details. The provided document concerns a physical medical implant (intervertebral body fusion device) and does not involve AI or algorithms in its described testing or equivalence claims.
In summary, the provided document is a regulatory submission focused on substantial equivalence based on technological characteristics and mechanical testing, not a detailed clinical study report with performance acceptance criteria for human efficacy.
Therefore, I cannot extract information regarding:
- A table of acceptance criteria and reported device performance (beyond a general statement of substantial equivalence).
- Sample sizes, data provenance, expert ground truth, or adjudication methods for clinical test sets.
- MRMC studies, effect sizes of AI assistance, or standalone algorithm performance.
- Type of ground truth used for clinical outcomes.
- Training set details for algorithms.
If you have a document that describes a clinical study or performance evaluation with specific acceptance criteria, I would be happy to try and extract that information for you.
§ 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.