(60 days)
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
The ATEC ALIF and LLIF Spacer System is an intervertebral body fusion system. The ATEC ALIF and LLIF Spacer System includes interbody implants marketed as Battalion Universal Spacer System and IdentiTi Porous Ti Spacer System, implanted from an anterior, anterolateral and lateral approach. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are manufactured from PEEK (polyetheretherketone) Optima LT1 per ASTM F2026, titanium coating per ASTM F1580, tantalum per ASTM F560, titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and commercially pure titanium (CPTi Grade 2) per ASTM F67. The device includes rows of teeth on the surface of each end of the device which serve to grip the adjacent vertebrae to resist migration and expulsion of the device. Additionally, the commercially pure titanium implants are offered with a microstructure due to the layering of material that forms the porous geometry. This porous geometry extends to the superior and inferior surfaces of the device for implant fixation. All interbody implants feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The ATEC ALIF and LLIF Spacer System also includes LLIF AMP integrated fixation to be used with the LLIF interbody offerings. The LLIF AMP integrated fixation includes fixation plates, center locking screws and bone screws manufactured from titanium alloy per ASTM F136.
The provided text is a 510(k) summary for the ATEC ALIF and LLIF Spacer System, which is an intervertebral body fusion system. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, and therefore does not require a Premarket Approval (PMA).
Crucially, this document is for a medical device (a physical implant) and not for an AI/ML-driven device or diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML model (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable here.
The "performance data" section in this document refers to nonclinical testing (mechanical, material, and biocompatibility testing) to demonstrate the physical device's safety and performance in a lab setting, and its substantial equivalence to other predicate devices.
Here's why the requested information cannot be extracted from this document:
- AI/ML Model: The device is an intervertebral body fusion system, not an AI/ML diagnostic or assistive tool.
- Performance Metrics: The "acceptance criteria" for this type of device are related to biomechanical properties (e.g., resistance to compression, shear, subsidence, push-out), material compatibility, and endotoxin levels, not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Clinical Studies (in the context of AI/ML): The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means formal clinical trials or multi-reader, multi-case (MRMC) studies with human readers were not required for this 510(k) clearance, as equivalence was demonstrated through nonclinical data and comparison to existing predicate devices.
- Ground Truth, Experts, Sample Sizes (for AI/ML): These concepts are entirely irrelevant for the clearance of a physical implant like the ATEC ALIF and LLIF Spacer System. There's no "ground truth" to establish for an AI model's output, no "experts" establishing image labels, and no "training/test sets" of data in the AI/ML sense.
In summary, the provided document does not contain the information requested because it pertains to the clearance of a physical medical implant, not an AI/ML-powered 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.