(143 days)
The Endoskeleton® TAS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolistiss at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The device is indicated to be used with autograft bone.
Hyperlordotic Devices ≥16°
The Endoskeleton® TAS Hyperlordotic Interbody Fusion Device(≥16°) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non to treatment with the devices. The device is indicated to be used with autograft bone. The Endosketon® TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.
The Endoskeleton® TAS Interbody Fusion Device and Endoskeleton® TAS Hyperlordotic Interbody Fusion Device implants are available in a variety of Anterior Lumbar Interbody Fusion (ALIF) sizes with a variety of lordotic angles, to accommodate patient anatomy; Hyperlordotic implants are those defined by a lordotic angle ≥ 16'. Implants are designed with a large hollow region in the center to house autograft bone material. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates "windows" through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces include either the previously cleared Chemtex® surface treatment or previously cleared nanoLOCK® surface treatment to improve fixation to the adjacent bone. The nanoLOCK® surface technology provides a microscopic roughened surface with nano-scale features. The implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space.
An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the interbody space. Screws include internal hex drive features matched to instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).
The provided document is a 510(k) summary for the Endoskeleton® TAS Interbody Fusion Device, particularly focusing on the hyperlordotic variant. This document primarily addresses the substantial equivalence of the device to previously marketed predicate devices rather than a study focused on meeting specific acceptance criteria for a new algorithmic device.
Therefore, the information requested in your prompt (acceptance criteria for an AI/algorithmic device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not present in this regulatory submission for a physical interbody fusion device.
This document describes the following physical device features and mechanical testing:
Device Description:
The Endoskeleton® TAS Interbody Fusion Device and Endoskeleton® TAS Hyperlordotic Interbody Fusion Device are Anterior Lumbar Interbody Fusion (ALIF) implants.
- Sizes and Lordotic Angles: Available in a variety of sizes and lordotic angles, with hyperlordotic implants defined as having a lordotic angle ≥ 16°.
- Design: Large hollow region in the center for autograft bone material, with "windows" for graft material visualization and new bone formation.
- Surfaces: Superior and inferior surfaces feature either Chemtex® or nanoLOCK® surface treatments for improved fixation. nanoLOCK® provides a microscopic roughened surface with nano-scale features.
- Fixation: Includes integrated fixation (screws) for stabilization.
- Material: All implantable components are made from medical-grade titanium alloy (Ti6A14V-ELI).
- Instrumentation: Implant holding feature on the trailing surface for placement; screws have internal hex drive features matching instrumentation.
Performance Testing:
Mechanical testing was performed to demonstrate substantial equivalence to predicate devices.
- Tests: Static compression shear, dynamic compression, dynamic compression-shear, subsidence, and expulsion tests.
- Standards: Performed according to ASTM F2077 and ASTM 2267.
- Additional Study: A cadaver study was performed, with radiographic and CAD analysis.
The document concludes that the mechanical testing data demonstrates that the Endoskeleton® TAS and nanoLOCK® TAS Hyperlordotic Interbody Fusion Devices are substantially equivalent to the predicate devices and do not raise new questions about safety and effectiveness.
§ 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.