(60 days)
The Navagio Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The Navagio Lumbar Cage was developed as an implant for the stabilization of the lumbar spinal column. The Navagio implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows to receive bone graft, which helps facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery. The components are available in a variety of sizes to more closely match the patient's anatomy.
Materials:
Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)
The provided text describes a medical device called the "Navagio Lumbar Cage" and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria through performance data.
Therefore, I cannot extract the detailed information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This information is typically found in clinical trial reports or performance testing summaries, which are not present in this 510(k) summary.
The document explicitly states:
- "NON-CLINICAL TEST SUMMARY: The following tests were conducted: Static and dynamic compression per ASTM F2077, Subsidence per ASTM F2267, Expulsion. The results of this testing indicate that the Navagio Lumbar Cage is substantially equivalent to predicate devices."
- "CLINICAL TEST SUMMARY: No clinical studies were performed."
This indicates that the assessment of the Navagio Lumbar Cage was based on non-clinical (mechanical) testing demonstrating equivalence to other already-approved devices, rather than a study with defined acceptance criteria and human performance metrics.
§ 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.