(141 days)
The MectaLIF Anterior Stand Alone system is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior Stand Alone can be packed with autograft or autologous bone graft.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The MectaLIF Anterior Stand-Alone is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand-Alone is intended to be used with bone screws provided and requires no additional supplementary fixation.
MectaLIF Anterior Stand-Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body. The spacer is available without any coatings and with a commercially pure titanium (CPTi, ASTM F 1580) coating. Both coated and uncoated spacers contain tantalum markers (ISO 13782 / ASTM F 560), and include bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and a plate made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136).
The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.
The purpose of this submission is to alter the indications for use, and introduce new plate and screw designs.
The provided text describes the MectaLIF Anterior Stand-Alone device and its performance testing as part of a 510(k) submission to the FDA. However, this document does not include specific acceptance criteria for performance metrics (such as a minimum load for static axial compression) or reported device performance in the format of a table with specific numerical results.
Instead, it lists the types of performance tests conducted and concludes that the device is substantially equivalent to predicate devices based on these tests and other characteristics.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text. I also cannot provide information on sample size for the test set, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance details, training set information, or how ground truth was established for the training set, as these details are not present in the document.
What the document does provide regarding device performance:
The document states that the following tests were conducted on the MectaLIF Anterior Stand-Alone in accordance with ASTM F2077, ASTM F2267, ASTM F1877, and ISO 17853:
- Static Axial Compression
- Dynamic Axial Compression
- Static Compression-Shear
- Dynamic Compression-Shear
- Static Torsion
- Dynamic Torsion
- Subsidence
- Expulsion
The conclusion is that based on the information presented, the MectaLIF Anterior Stand Alone is substantially equivalent to the predicate devices. This implies that the device met the performance requirements demonstrated by the predicate devices through these tests, but the specific numerical acceptance criteria and reported results are not detailed in this public summary.
In summary, the provided document largely focuses on regulatory and descriptive aspects of the device, rather than a detailed report of performance study results against specific criteria.
§ 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.