(29 days)
When used as a lumbar intervertebral body fusion device, the 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 or retrolisthesis 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 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 subject Biomet Spine Fusion System implant is provided sterile only.
This document describes a 510(k) premarket notification for the Biomet Spine Fusion System. The submission is to add a tantalum marker to the cam locking mechanism of the existing device. This is a modification to an existing device, not a new AI/ML-enabled device, and therefore does not include the detailed performance study information typically associated with AI/ML device submissions.
Here's a breakdown of the information provided, tailored to the requested categories where applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Demonstrate substantial equivalence to predicate device (K151483) as per FDA guidance and ASTM standards (ASTM F2077 for static/dynamic axial compression, static/dynamic shear compression, static torsion; ASTM F2267 for subsidence). | An engineering analysis demonstrated that no new mechanical testing was required for the modified device (adding a tantalum marker). The analysis demonstrated substantial equivalence of the new subject devices to the predicate device. The modified Biomet Spine Fusion System met all specified criteria. |
Mechanical testing on the predicate device (K151483) was conducted and demonstrated substantial equivalence to its own predicate devices. |
| Safety and Effectiveness: The modifications should not raise new safety or performance questions. | The modified Biomet Spine Fusion System met all specified criteria and did not raise new safety or performance questions. The minor differences in the new components (tantalum marker) do not raise any new issues of safety or effectiveness. |
| Intended Use & Indications for Use: Maintain the same intended use and indications for use as the predicate. | The modified Biomet Spine Fusion System implants included in this submission have the same intended use, indications, technological characteristics, and principles of operation as the previously cleared Biomet Spine Fusion System (K151483). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. For this specific 510(k) submission, there isn't a "test set" in the context of clinical data for an AI/ML device. The evaluation was primarily engineering analysis and mechanical testing comparison to a predicate device.
- Data Provenance: Not applicable. The "data" here refers to mechanical testing results and engineering analysis, not patient data.
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):
- Not applicable. This is not an AI/ML device requiring expert ground truth for image or clinical interpretation. The evaluation was based on engineering and mechanical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, there is no "test set" in the sense of clinical data requiring adjudication.
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:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the predicate device's mechanical testing, the "ground truth" would be the established ASTM standards (F2077, F2267) and the performance criteria outlined in FDA guidances (Spinal System 510(k)s, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device). For the current submission, the ground truth is simply the established safety and performance of the predicate device (K151483) against which the minor modification is compared via engineering analysis.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary, this 510(k) is for a minor modification (adding a tantalum marker) to an existing, previously cleared spinal fusion device. The "study" proving the device meets acceptance criteria is an engineering analysis, which determined that the modification did not alter the mechanical performance or safety/effectiveness of the device and thus no new mechanical testing or clinical studies were required beyond what was done for the original predicate device.
§ 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.