(135 days)
FlareHawk™ Interbody Fusion System is indicated for spinal intervertebral body fusion with autogenous bone graft and/ or allogeneic bone graft composed of cancellous and/or corticocancellous bone in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, following discectomy. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) months of non-operative treatment. Additionally, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). FlareHawk™ system spacers are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Integrity Implants' FlareHawk™ Interbody Fusion System is an expandable lumbar intervertebral body fusion device intended for use in the lumbosacral spine from L2 to S1. The FlareHawk™ interbody fusion device consists of a shell and a shim component that are offered in various lengths, heights, and lordotic angles to accommodate variations in patient anatomy. When the FlareHawk™ device is deployed within the intervertebral disc space, the shell and shim components lock together to create a complete implant construct to provide structural stability for interbody fusion. The final dimensions of the deployed device construct are determined by the dimensions of the selected shell and shim. Once implanted, the FlareHawk™ interbody fusion device is designed to restore intervertebral disc height, provide anterior column support, and maintain structural stability of the motion segment to facilitate intervertebral body fusion. The FlareHawk™ interbody fusion device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone, and with supplemental fixation instrumentation that has been cleared for use in the lumbar spine. The FlareHawk™ Interbody Fusion System includes manual surgical instruments for delivery of the implant device and for disc preparation. FlareHawk™ Interbody Fusion System implant and instrument devices are supplied non-sterile and are intended for steam sterilization by the user prior to use.
I apologize, but the provided text from the FDA 510(k) Premarket Notification document for the "FlareHawk™ Interbody Fusion System" does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The document describes a traditional medical device (an intervertebral body fusion system) and its mechanical testing for safety and performance (e.g., static and dynamic compression, subsidence testing). It focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and mechanical strength.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided input, as the nature of the device and the testing described are not related to AI/ML performance.
If you have a document describing an AI/ML medical device, I would be happy to help analyze it according to the criteria you've outlined.
§ 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.