(64 days)
The GS Medical PYXIS 3D Titanium Cervical Cages indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. GS Medical PYXIS 3D Titanium Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical PYXIS 3D Titanium Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The GS Medical PYXIS 3D Titanium Cervical Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The intervertebral body fusion devices are made of 3D printed titanium alloy (Ti-6Al-4V) in accordance with and manufactured as per ASTM F3001. The material and manufacturing process of the subject device, PYXIS 3D Titanium Cervical Cage is identical to the additional predicate (PYXIS 3D Titanium Cage System, K223868). The PYXIS 3D Titanium Cervical Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions. The subject device cages ranging in height from 5mm-10mm in 1 mm increments with 0°, 4°, and 8° options. Also in 4.5mm hight for the 0° angle. The cages are provided in three distinct footprints.
This FDA document is a 510(k) premarket notification for a medical device called the PYXIS 3D Titanium Cervical Cage System. It describes the device and claims substantial equivalence to previously cleared predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria in the context of an AI/ML powered device, or any kind of AI/ML component at all.
The "PERFORMANCE DATA" section (page 5) simply states that "The worst-case cage of the PYXIS 3D Titanium Cage System underwent testing according to ASTM 2077, specifically static and dynamic axial compression testing, static and dynamic compression shear testing, static and dynamic Torsion testing; expulsion testing, and subsidence testing according to ASTM F2267." These are standard mechanical and structural tests for intervertebral body fusion devices, not performance metrics related to an AI/ML algorithm.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study details for an AI/ML device based on the provided text. The device in question is a purely mechanical implant.
§ 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.