(85 days)
The NexGen Standalone ACDF System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The NexGen implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System implants are available in various heights and geometric footprints to accommodate individual patient anatomy and graft material size. NexGen Interbody devices are inserted through an anterior cervical approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior titanium portion of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All implantable components are made from medical grade polyetheretherketone (PEEK), tantalum, and titanium or titanium alloy as described by such standards as ASTM F2026, ASTM F560, and ASTM F136/ISO 5832-3. The products are supplied clean and non-sterile.
This document is a 510(k) Premarket Notification from the FDA regarding the "NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System." It is a regulatory clearance document, not a study report that details acceptance criteria and device performance in the way requested for an AI/ML medical device.
Therefore, I cannot provide the requested information as the document does not contain details about:
- A table of acceptance criteria and reported device performance related to a study proving the device meets acceptance criteria (as would be seen for an AI/ML device validating its performance metrics like sensitivty/specificity). Instead, the performance data cited is for mechanical testing of an orthopedic implant.
- Sample sizes for a test set or training set for AI/ML.
- Data provenance, expert qualifications, or adjudication methods for ground truth, as these relate to the assessment of an AI's diagnostic or predictive capabilities.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Type of ground truth used in the context of an AI/ML study (e.g., expert consensus, pathology, outcomes data).
The "Performance Data" section in the document refers to mechanical performance testing (e.g., static and dynamic axial compression, compression shear, torsion, subsidence) against ASTM standards, which are entirely different from the performance metrics and study methodologies used to validate AI/ML medical devices.
This device is an orthopedic implant, and its clearance is based on substantial equivalence to predicate devices through mechanical testing, material characterization, and indications for use, not through a clinical performance study involving AI/ML algorithms.
§ 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.