(15 days)
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.
The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies.
OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6 to 14 degrees) and two footprints to accommodate variations in patient anatomy. The fixation plates are manufactured from Titanium (ASTM F136), and the end caps are available in PEEK (ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136), and are plasma sprayed with CPtitanium (ASTM F1580). The bone screws manufactured from Titanium (ASTM F136) are Ø5mm and are available in lengths from 24 to 32mm.
This document is a 510(k) premarket notification from the FDA regarding the "Optimus ALIF System," an intervertebral body fusion device. The purpose of this specific submission is for a modification to a trial distractor instrument, not the core device itself. As such, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data for the main implant.
Therefore, the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-as-a-medical-device type evaluations) is not applicable to this document. This submission is for a physical medical device (spinal implant) and its associated instrument, and the "performance testing" mentioned refers to cleaning and sterilization validation, not clinical efficacy or diagnostic accuracy studies typically associated with AI.
Here's why the questions are not applicable and what information can be gleaned:
- 1. A table of acceptance criteria and the reported device performance: This document does not contain such a table. The device is a physical implant, and its performance is assessed through substantial equivalence to a predicate device and via mechanical testing (which is not detailed in this summary). The summary mentions "Cleaning and steam sterilizations were performed to verify method suitability," which are performance tests for those specific aspects, not for the clinical performance of the implant.
- 2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There isn't a "test set" in the context of diagnostic performance.
- 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 a diagnostic device requiring expert interpretation of results.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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/diagnostic assistance device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a spinal implant's mechanical performance would come from engineering and biomechanical testing standards, which are not detailed here. Clinical success would be measured through patient outcomes in post-market studies, but this document is a pre-market clearance based on equivalence.
- 8. The sample size for the training set: Not applicable. There is no training set for an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
Information that can be extracted from the document related to the device:
- Device Name: Optimus ALIF System
- Predicate Device: Optimus ALIF System (K132596) - This indicates that the current submission is for a modification to an already cleared device, relying heavily on the equivalence to the original.
- Purpose of Submission: A special 510(k) for a modification to the Optimus Stand-Alone ALIF System, specifically for the trial distractor instrument. This means the core implant design, materials, and function for which it was originally cleared are unchanged ("There are no changes being proposed for the Subject Device with respect to intended use, design, material composition, and function.").
- Performance Testing Mentioned: "Cleaning and steam sterilizations were performed to verify method suitability." This refers to validation of sterilization processes for the instrument, not clinical performance of the implant.
- Conclusion: "Based on comparison to the predicate device, the Subject Device has been shown to be substantially equivalent."
§ 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.