(134 days)
FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).
FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation (i.e. Firebird® Spinal Fixation System).
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with FORZA XP Expandable Spacer System.
The FORZA XP Expandable Spacer System consists of various size and style options to address the clinical and anatomic needs of individual patients. The implant is rectangular in its general shape with the capability to expand in height continuously within its design limitations. The implant incorporates bone graft cavities through the superior and inferior surfaces to allow fusion between adjacent vertebral bodies. The implant incorporates a posterior opening to allow the addition of bone graft material post expansion. The implants are manufactured from implantable grade Ti6Al4V alloy and PEEK Optima LT1. The implants are delivered pre-assembled, unexpanded and are designed with textured bone contacting surface to resist migration /expulsion post operatively.
The provided text describes a 510(k) premarket notification for the "FORZA® XP Expandable Spacer System," an intervertebral body fusion device. This document details the device's characteristics, intended use, and its substantial equivalence to legally marketed predicate devices based on non-clinical performance data.
However, the information provided does not contain any details about an AI/ML-driven device, nor does it discuss clinical studies with human readers, ground truth establishment, or specific acceptance criteria for AI model performance.
The document specifically mentions:
- "Based on design change and risk assessment the mechanical tests performed were Static and Dynamic Axial Compression Tests and Static and Dynamic Compression Shear Tests in accordance to the ASTM F2077-14 standard for Test Method for Intervertebral Body Fusion Devices."
This indicates that the "performance data" refers to mechanical testing of the physical implant device, not to the performance of an AI/ML algorithm.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves an AI/ML device meets those criteria based on the provided text. The provided text describes a physical medical device (an intervertebral spacer) and its mechanical testing for compliance with an ASTM standard, which is unrelated to AI/ML performance evaluation.
§ 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.