(57 days)
The Foundation-LL System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved level(s). The Foundation-LL System is intended for use with autograft. The Foundation-LL System must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Foundation-LL System.
The NuVasive Foundation-LL System is an interfixated interbody system manufactured from PEEK-Optima LT-1 conforming to ASTM F2026, with commercially pure titanium coating conforming to ASTM F1580 and internal screw hole rings made of titanium allov (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3. The tantalum radiographic markers conform to ASTM F560. The bone screws are made of titanium allov (Ti-6AI-4V ELI) conforming to ASTM F136 and ISO 5832-3. The NuVasive Foundation-LL System is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The Foundation-LL System consists of a PEEK interbody or PEEK interbody with a commercially pure titanium plasma coating, and three (3) titanium alloy bone screws. The Foundation-LL System must be used with supplemental internal spinal fixation systems (i.e. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific criteria for performance and effectiveness. The text discusses the FDA's 510(k) clearance for a medical device called the "NuVasive® Foundation-LL System," which is an intervertebral body fusion device.
The document primarily focuses on regulatory approval, indicating that the device is substantially equivalent to previously marketed predicate devices. It lists the device's indications for use, technological characteristics, and nonclinical performance testing conducted (e.g., static and dynamic compression testing, wear debris testing, push-out testing, subsidence testing). However, these tests are mentioned as having been performed to demonstrate substantial equivalence to predicate devices, and the document states that the results show the system meets or exceeds the performance of the predicate device and does not introduce any new risks.
It does not provide:
- A table of acceptance criteria and reported device performance against those criteria.
- Details about sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance, as the device is a physical implant and not an AI or diagnostic software.
- Details on the sample size or ground truth establishment for a training set.
Therefore, I cannot provide the requested information for this specific document.
§ 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.