(99 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 20 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.
Biomet Fusion System implants consist of a spacer body with screws for additional fixation. The Biomet Fusion System the spacer body is made from PEEK-OPTIMA® LT1, a polyaromatic semicrystalline thermoplastic polymer (-C,Hz-O-C,Hz-O-C,Hz-CO-). The Biomet Fusion System implants include an anterior plate and screws made from an implant grade titanium alloy (Ti-6Al-4V ELI) meeting the requirements of ASTM F136-08 and ISO 5832-3. The spacer body, 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.
The implants included in this application are intended for us in lumbar intervertebral body fusion. The implants have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of each implant have a series of transverse grooves formed to improve stability and fixation once the device is inserted.
The purpose of this 510(k) Notification is to seek clearance for a modification to the Lanx Fusion System, for additional configurations. The new implants are also referred to as the Biomet Fusion System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biomet Fusion System, broken down by your requested categories:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Static Compression (per ASTM F2077) | Met acceptance criteria and functioned as intended. |
| Static Compression Shear (per ASTM F2077) | Met acceptance criteria and functioned as intended. | |
| Static Torsion (per ASTM F2077) | Met acceptance criteria and functioned as intended. | |
| Dynamic Compression (per ASTM F2077) | Met acceptance criteria and functioned as intended. | |
| Device Stability/Fixation | Expulsion Testing (per ASTM Draft Z8423Z) | Met acceptance criteria and functioned as intended. |
| Clinical Performance (implied) | Cadaveric Study | Met acceptance criteria and functioned as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the mechanical tests. For the cadaveric study, the sample size is not specified. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the studies were primarily mechanical and cadaveric performance tests, not studies requiring expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for mechanical and cadaveric performance tests. The "ground truth" for these tests is determined by the physical properties and behavior of the device under specific, standardized conditions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or mentioned in this document. This is a medical device (spinal implant) and the performance evaluation focuses on its mechanical properties and functionality, not diagnostic interpretation by human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical spinal implant, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical tests, the "ground truth" is defined by the acceptance criteria of the relevant ASTM standards. For the cadaveric study, the "ground truth" would be the observed physical performance and stability of the device within the cadaveric specimens, measured against pre-defined performance metrics (though these specific metrics are not detailed in the summary).
8. The sample size for the training set
This is not applicable as the Biomet Fusion System is a physical medical device undergoing mechanical and cadaveric testing, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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.