(176 days)
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System ("Biomet Spine 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 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). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement
The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have a hollowed out central area to accommodate bone graft. The upper and lower surfaces of the devices have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of PEEK (OPTIMA LT1®) per ASTM F2026, titanium alloy (Ti-6A1-4V ELI) per ASTM F136, commercially pure titanium per ASTM F1580, and may include tantalum markers per ASTM F560. The expandable Biomet Spine Fusion System implants incorporate PEEK (OPTIMA LT1® per ASTM F2026) spacer components and titanium alloy (Ti-6Al-4V ELI per ASTM F136) endplate components that orient into predetermined lordotic angles of 0, 8 and 12 degrees. The expandable implants are available in 7 to 14mm heights, an 11mm width, and 25, 30 and 35mm lengths. The Biomet Spine Fusion System is intended to be sterile.
This document describes the Biomet Spine Fusion System, an intervertebral body fusion device. The provided text is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study.
Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and training set information) are not available from this regulatory submission. This document primarily details mechanical testing and comparison to predicate devices.
Here's a breakdown of the information that is available and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by testing standards) | Reported Device Performance (from text) |
|---|---|
| Static and dynamic axial compression (ASTM F2077) | Met or exceeded predicate device performance |
| Static and dynamic shear compression (ASTM F2077) | Met or exceeded predicate device performance |
| Static torsion (ASTM F2077) | Met or exceeded predicate device performance |
| Subsidence (ASTM F2267) | Met or exceeded predicate device performance |
| Particulate wear analysis (ASTM F1877) | Met or exceeded predicate device performance |
Note: The specific numerical acceptance criteria for "met or exceeded predicate device performance" are not provided in this document.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The "tests" mentioned are mechanical performance tests of the device itself, not clinical trials on patient data.
- Data Provenance: Not applicable. These are laboratory mechanical tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically understood in a clinical study (e.g., diagnosis, outcome) is not relevant for the mechanical tests described.
4. Adjudication method for the test set
- Not applicable. Mechanical tests do not involve adjudication by experts.
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 MRMC comparative effectiveness study was done. This device is an intervertebral body fusion system, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical implant, not an algorithm. The performance tests are for the physical device.
7. The type of ground truth used
- Not applicable in the clinical sense. For mechanical tests, the "ground truth" would be the engineering specifications and performance benchmarks derived from the relevant ASTM standards and predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.