(124 days)
The PYXIS 3D Titanium Cage System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.
The GS Medical PYXIS 3D Titanium Cage System devices are designed for restoring the height of the intervertebral space after resection of he disc. They system consists of various cages for intervertebral body fusion ranging in height from 5mm-21mm with multiple lordotic options depending on the approach.
The components are manufactured from 3D printed Titanium Alloy (Ti-6Al-4V ELI) meeting the specifications of ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion.
The PYXIS 3D Titanium Cage System implants are available in various heights, footprints, and lordotic angles to suit the individual patient's pathology and anatomical conditions.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for a medical device that involves artificial intelligence or software performance.
The document is a 510(k) premarket notification for the PYXIS 3D Titanium Cage System, which is an intervertebral body fusion device made of titanium alloy for spinal surgery. The performance data mentioned (Section VI) relates to biomechanical testing of the physical implant (e.g., static and dynamic axial compression, shear, expulsion, and subsidence testing), not to the performance of an AI/software device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/software device.
- Sample size and data provenance for a test set for an AI/software device.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size.
- Ground truth establishment for the training set.
The document discusses the substantial equivalence of a physical medical implant (cage) to predicate devices based on its intended use, technological characteristics (material, design, dimensions), and biomechanical performance. It does not describe any AI/software component or related performance studies.
§ 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.