(119 days)
Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textures are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device.
Additionally, the Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.
The Anteralign™ Spinal System™ with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. These implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign Spinal System must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.
Miniplate and bone screw components are provided as an option for the lumbosacral levels oblique or lateral above the bifurcation (L2-L5) of the vascular structures. Indications of spinal instrumentation systems should be understood by the surgeon.
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
The Anteralign™ Spinal System with Titan nanoLOCK" Surface Technology consists of interbody cages, mini plates, bone screws and non-navigated instruments. The Anteralign™ Spinal System interbody cage, known as Anteralign™ TL, is an additive manufactured titanium cage available in various heights, widths, and lengths with different lordosis options to accommodate patient anatomy. The interbody cages are inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The Anteralign™ TL interbody fusion device is rectangular shaped with a large hollow region in the center to house autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The interbody design incorporates honeycomb windows and an open void to allow bone growth through the implant.
The interbody device is treated with Titan Surface Technology, where nanoLOCK™ Surface Technology (MMN) is designed to improve fixation to the adjacent bone. The nanoLOCK" Surface Technology provides a microscopic-roughened surface with nano-scale features. The nanoLOCK™ Surface Technology is specifically engineered to have nano-textured features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. The nanoLOCK™ Surface Technology demonstrates the elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance.
Anteralign™ TL implants are provided sterile and are intended to be used with supplemental fixation cleared for use in lumbar spine (L2-S1) procedures and may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach.
Mini plates and screws are provided as options for anti-migration of the Anteralign™ TL interbody. The miniplate is additively manufactured from titanium powder with a machined-wrought titanium bolt. The miniplate may be positioned either laterally or obliquely and oriented in either cephalad or caudal direction on the Anteralign™ TL cage. The bone screw, which is manufactured from wrought titanium, is then placed through the miniplate intrinsic screw hole. Mini plates and bone screws are offered in various sizes and are provided sterile.
Stainless steel and titanium implants are not compatible. They must not be used together in a construct.
The purpose of this Traditional 510(k) submission is to seek clearance for the Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology devices and demonstrate compatibility of the Anteralign™ Navigated inserter with the Stealth Station™ System S8 Spine Software (K201189, S.E. 05/29/2020).
I am sorry, but the provided text from the FDA 510(k) Premarket Notification for the "Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology" does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, especially not for an AI/ML powered device.
The document primarily focuses on:
- Device Description: What the device is, its components (interbody cages, mini plates, bone screws), and its material.
- Indications for Use: The medical conditions the device is intended to treat and how it's used (e.g., spinal fusion for DDD, spondylolisthesis).
- Predicates: Other similar devices already on the market to which this new device is compared for substantial equivalence.
- Performance Data (General): It lists types of performance tests conducted (e.g., ASTM standards for mechanical properties like compression fatigue, subsidence, expulsion) and mentions verification and validation activities for navigated instruments.
Here's why the requested information cannot be extracted from this document:
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Nature of the Device: The Anteralign™ Spinal System is an interbody spinal fusion device and navigated surgical instruments. It is a physical implant and associated tools, not an AI/ML-powered diagnostic or assistive software that would have "acceptance criteria" related to performance metrics like sensitivity, specificity, or accuracy, nor would it involve a "test set" with ground truth established by experts.
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No AI/ML Component Described: The document makes no mention of artificial intelligence, machine learning, or algorithms that would perform diagnostic or assistive functions. The "Titan nanoLOCK™ Surface Technology" refers to a physical surface feature designed to enhance bone fixation, not an AI component. The "StealthStation™ System" is a navigation system, but the document does not describe its use as an AI-powered diagnostic tool, but rather as one to assist in precise anatomical location during surgery.
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Type of Performance Testing: The performance data mentioned (ASTM standards) are for mechanical and physical properties (e.g., how the implant withstands force, resists subsidence) and sterile/use compatibility, which are typical for medical implants and instruments. They are not "study" results that would involve patient data interpretation or multi-reader studies.
Therefore, I cannot provide the requested table and study details because the provided document does not describe an AI/ML device or its associated performance study against defined acceptance criteria for such a device.
To answer your prompt, I would need a regulatory document (like a 510(k) summary or a similar report) for an AI/ML-based medical device that clearly outlines its clinical performance study.
§ 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.