(74 days)
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had at least six weeks of non-operative treatment. The Biomet Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s). Implants with 14 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.
When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System ("Biomet Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Biomet Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
The subject Biomet Fusion System has the same or similar intended use, indications for use, technological characteristics and principles of operation as the intervertebral body fusion devices which were reclassified as explained in FDA's guidance document, "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007). The subject Biomet Fusion is substantially equivalent to the previously cleared Biomet Fusion System (K141791).
The Biomet Fusion System is intended for use in intervertebral body fusion or vertebral body replacement. However, the implants included in this application are intended for use in lumbar intervertebral body fusion only. The subject implants are a line extension of those currently available in the Biomet Fusion System. Modifications have been made to the currently available Biomet Fusion System implants to add additional plate heights (18mm and 20mm) in both 1-hole and 2-hole configurations as well as to add a new 14degree spacer option. As a result of these new 18mm and 20mm plates and 14 degree spacers, taller cover plates, implant trials, and implant caddies were developed to correspond to the new implant sizes.
The Biomet Fusion System implants consist of a spacer body and plates with screws for additional fixation. The spacers are made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-CcH4-O-CcH4-O-CcH4-CO-), with tantalum markers. The plates and screw are made from implant grade titanium alloy (Ti-6AI-4V ELI) meeting ASTM F136-08 and ISO 5832-3. The Biomet Fusion System spacers, plates, and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Biomet Fusion System is provided non-sterile.
I'm sorry, but this document does not contain the information required to answer your request. The document describes a medical device, the "Biomet Fusion System," and its indications for use, as well as a comparison to a predicate device. However, it does not include details of a study that establishes acceptance criteria for performance, nor does it present data on reported device performance in the format of acceptance criteria.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Details on standalone algorithm performance.
- The type of ground truth used.
- Sample sizes for training sets.
- How ground truth for training sets was established.
Instead, the document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K141791) based on intended use, indications for use, technological characteristics, and principles of operation, along with a risk analysis.
§ 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.