(121 days)
Fusion Advantage Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radioular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Fusion Advantage Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Fusion Advantage Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The Fusion Advantage Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Fusion Advantage Lumbar Cage implants are to be used with autogenous bone graft and implanted via an open posterior, transforaminal or an lateral approach. The Fusion Advantage Lumbar Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous nonfusion spinal surgery at involved level may be treated with the device.
The Adaptive Specialty Fusion Advantage cervical cage was developed as an intercorporal implant for anterior cervical spondylodesis. The Fusion Advantage System was especially adapted to the local anatomy in order to secure the surgical result as well as possible. Its inferior and superior sides are flat with ridges on both surfaces to prevent migration. The implant is oval shaped with a large central graft space to help facilitate bony integration once implanted. In the lateral view, the implant has a 2.5° lordotic form.
The Adaptive Specialty Fusion Advantage Lumbar cage was developed as an implant for the posterior stabilization of the lumbar spinal column. The Adaptive Specialty Fusion Advantage implant has ridges on both its inferior and superior surfaces to prevent migration. It is a rectangular shape with a large rectangular graft space and lateral holes help facilitate bony integration once implanted.
Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)
Function: To maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion.
The provided text describes the Fusion Advantage Interbody Cages, a medical device for spinal fusion. However, it does not contain information about a study proving the device meets acceptance criteria in the context of AI/ML performance metrics, or clinical study data.
The relevant sections of the document are a 510(k) Summary and the FDA's clearance letter. These documents focus on demonstrating substantial equivalence to previously cleared devices based on non-clinical tests (mechanical strengths) and intended use, not on a study with acceptance criteria related to AI/ML or human reader performance.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about MRMC or standalone studies, as this information is not present in the provided text.
The document primarily states:
- 7. Summary of Nonclincal Tests: "Tests performed according to ASTM F2077/F2267 indicate that the Interbody Fusion Advantage Interbody Cages meet required mechanical strengths."
This indicates that the acceptance criteria are related to mechanical strength tests defined by ASTM standards, and the device met these engineering standards. The document does not elaborate on specific numerical acceptance criteria or detailed results of these tests, beyond stating they were met.
§ 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.