(358 days)
The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment prior to treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.
The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6° and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile.
This is a 510(k) premarket notification for a medical device (Hexanium® ACIF, an intervertebral body fusion device) seeking substantial equivalence to a predicate device, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design, ground truth, sample sizes for training/test sets, expert adjudication, and MRMC studies is not applicable in this context.
The document states:
- "No clinical data has been presented." This means no human study was performed to assess the performance of the device in patients.
- "The following non-clinical tests were conducted: static and dynamic axial compression, static and dynamic shear compression, static and dynamic torsion testing according to ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing. Results demonstrate comparable mechanical properties to the predicate device." This indicates the performance data relates to mechanical properties tested in a lab setting, not clinical performance or AI/ML algorithm performance.
The acceptance criteria for this device would be based on these mechanical tests demonstrating equivalence to the predicate device, generally through meeting established ASTM standards. The "performance data" section states that the device demonstrated "comparable mechanical properties to the predicate device," which implies it met the acceptance criteria for these physical tests.
Since this is a traditional medical device submission and not an AI/ML device, the detailed requirements for AI/ML performance studies (like MRMC, standalone performance, ground truth establishment, expert qualifications, etc.) are not relevant here.
§ 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.