(154 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 via a transforaminal (TLIF) or posterior (PLIF) approach, 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.
The provided text is a 510(k) summary for a medical device called the "FlareHawk™ Interbody Fusion System." This documentation describes the device, its intended use, and its equivalence to legally marketed predicate devices based on non-clinical tests.
Crucially, the text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to a diagnostic or AI-driven medical device. This document is for an orthopedic implant and focuses on mechanical performance and substantial equivalence to previously cleared implants, not on the performance metrics typically associated with AI/diagnostic devices (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description and Indications for Use: What the FlareHawk™ Interbody Fusion System is and what it's used for (spinal intervertebral body fusion).
- Technological Characteristics: Materials, design, and function of the implant.
- Predicate Devices: Identification of legally marketed devices to which the FlareHawk™ system is substantially equivalent.
- Non-Clinical Testing: References to ASTM standards (F2077, F2267) for mechanical testing (static compression, dynamic compression, shear, subsidence) to demonstrate performance comparability to predicates.
There is no mention of an AI component, diagnostic function, human reader studies (MRMC), or any of the detailed performance metrics (sensitivity, specificity, etc.) typically required for acceptance criteria of an AI/diagnostic device.
To answer your request, the input text would need to be from an FDA submission related to a diagnostic device, particularly one employing AI.
§ 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.