(364 days)
The NEST Interbody System is indicated for interbody fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should be skeletally mature and have six months of non-operative treatment. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s).
The NEST Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
The NEST Interbody System is an intervertebral body fusion cage which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow, rectangular implant consists of both solid and porous structures and serrations on the superior and inferior porous surfaces are for enhanced fixation.
The implant is designed to be used with supplemental fixation with cleared for use in the lumbosacral spine. The implant is offered in a variety of sizes to accommodate a variety of patients' anatomy. NEST is additively manufactured from Ti6Al4V alloy (ASTM F3001) and is provided sterile.
The provided text describes a medical device, the NEST Interbody System, and its 510(k) submission to the FDA. However, it does not contain specific acceptance criteria, reported device performance data, study details (like sample size, data provenance, expert qualifications, or adjudication methods), or information about AI assistance or standalone algorithm performance.
The document focuses on:
- Product Information: Device name, regulation number, regulatory class, product code, indications for use.
- Manufacturer Information: Company name, contact person, date prepared.
- Predicate Devices: Identifying legally marketed predicate devices for substantial equivalence.
- Device Description: General features, material (Ti6Al4V alloy), and intended use.
- Summary of Non-Clinical Testing: Mentioning compliance with FDA guidance and specific mechanical tests performed (Static Compression, Dynamic Compression, Static Compression Shear, Static Torsion, Subsidence per ASTM F2077 and F2267).
- Conclusion: Stating substantial equivalence based on design, materials, features, indications, and mechanical testing results.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study details because it is not present in the provided text. The document pertains to a traditional 510(k) submission for a physical medical implant, not an AI/ML-driven device, so questions related to human reader improvement with AI assistance or standalone algorithm performance are not applicable based on the given information.
§ 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.