(53 days)
The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.
The MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation is a spinal intervertebral body fusion device used to provide structural stability following lateral lumbar interbody fusion for lumbar degenerative disorders.
The MiRus 3DR LLIF is additively manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F3001.
The MiRus MoRe Lateral Lumbar Plating System consists of a lateral plate manufactured from Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, bone screws, locking cam mechanism, and a connecting screw manufactured from Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136.
Instrumentation is manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
This is an FDA 510(k) clearance letter for a medical device, the MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation. This document does not describe:
- A table of acceptance criteria and reported device performance related to AI/algorithm performance. It describes mechanical performance testing of the physical device.
- Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI model.
- Any mention of a Multi-Reader Multi-Case (MRMC) study or standalone algorithm performance.
- Training set details for an AI model.
The document focuses on the mechanical testing of the interbody fusion system to demonstrate its substantial equivalence to predicate devices, not the performance of an AI or algorithmic medical device.
Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/algorithm-based device from the provided text. The text specifically details the mechanical performance assessment of a physical implantable 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.