(154 days)
The FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the FIX-C PEEK Anterior Cervical Interbody System should be packed with autogenous bone graft and implanted via an anterior approach. The FIX-C PEEK Anterior Cervical Interbody System is intended to be used with supplemental fixation.
The FIX-C PEEK Anterior Cervical Interbody System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The FIX-C PEEK Anterior Cervical Interbody System devices are designed for an anterior approach.
The provided document is a 510(k) summary for the "FIX-C PEEK Anterior Cervical Interbody System." This type of document is for a medical device that achieves FDA clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a process requiring a clinical study with detailed acceptance criteria for AI/ML performance.
Therefore, the requested information regarding acceptance criteria, study details involving AI/ML performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and training set details is not applicable to this submission.
The document primarily focuses on demonstrating equivalence through:
- Indications for Use: Stating the same intended use as the predicate device (FIX-C PEEK Anterior Cervical Interbody System is indicated for use in skeletally mature patients with degenerative disc disease at one level from C2-T1).
- Technological Characteristics Comparison: A table (on page 5) compares the subject device to the predicate device (K120275) showing "Equivalent" or "Similar" conclusions for parameters like design/shape, depth/width, height, bone graft contact area, materials (PEEK and Ti-6AL-4V ELI), sterilization, biocompatibility, and performance (based on ASTM standards for mechanical testing).
The "performance" mentioned in the document refers to mechanical and material performance testing (non-clinical verification), not to the performance of an AI/ML algorithm in image interpretation or diagnosis. Specifically, the performance criteria are based on recognized standards such as ASTM F2077 and ASTM F2267, which cover static and dynamic torsion, axial compression, compression shear testing, and subsidence testing of interbody fusion devices.
In summary, this document does not contain information about acceptance criteria or a study that proves an AI/ML device meets acceptance criteria because the device is a spinal implant, not an AI/ML diagnostic or assistive tool.
§ 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.