(184 days)
The ARTFX Lumbar PEEK Cages are indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have received at least six (6) months of prior non-operative treatment.
The devices are designed to be used with supplemental fixation and autograft/autologous bone grafts to facilitate fusion for each spinal region.
The ARTFX Lumbar PEEK Cages consist of 3 different models: TLIF, PLIF and Expandable PLIF. The System implants are supplied sterile, for single use and are fabricated from PEEK Optima that conforms to ASTM F2026. Various sizes of these components are available.
The Lumbar Cages are lumbar intervertebral devices to be implanted into the appropriate lumbar vertebral section to help provide stability for spinal fusion after a diseased lumbar disc producing back pain is removed during spinal decompression.
ARTFX Lumbar PEEK Cages feature an open cavity to accommodate autogenous bone graft and provide stability for fusion. The height of the Expandable PLIF device, can be increased by up to 2 mm due to the expandable structure. Also, sharp teeth on the implant's surface engage the vertebral endplates to prevent cage migration.
The provided document is a 510(k) premarket notification letter from the FDA regarding ARTFX Lumbar PEEK Cages. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on material, design, and function.
However, the document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria related to AI/algorithm performance, clinical effectiveness, or human reader improvement with AI assistance.
The information provided pertains to the substantial equivalence determination for a physical medical device (intervertebral body fusion cages), not an AI/software as a medical device (SaMD). The review process for such a device primarily involves demonstrating:
- Same intended use as a predicate device.
- Same technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness. This is typically assessed through non-clinical (bench) testing and material compliance.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/algorithm performance, clinical study design (sample size, ground truth, experts, MRMC studies, etc.). The document explicitly states:
- Non-clinical testing (bench testing) was conducted: "Non-clinical testing including static and dynamic axial compression and compression-shear testing in accordance with ASTM F2077 and subsidence per ASTM F2267 were conducted."
- Result of the non-clinical testing: "The results showed that the performance of the proposed devices is substantially equivalent."
The context of your questions (acceptance criteria for device performance, ground truth, expert consensus, MRMC studies, training/test sets, etc.) is highly relevant for Artificial Intelligence/Machine Learning (AI/ML) based medical devices or those requiring clinical effectiveness studies, which is not the subject of this FDA clearance letter.
§ 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.