(309 days)
The Altus Spine Interbody Standalone Fusion System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
When used with both the cover plate and four (4) provided screws, the Altus Spine Interbody Standalone Fusion System requires no additional supplemental fixation. In any other instance, additional supplemental fixation systems cleared by the FDA for use in the lumbar spine must be used.
Implants with hyperlordotic angles > 20 degrees, regardless of screw usage, must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The interior of the interbody spacer component is intended to be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone.
The Altus Spine Interbody Standalone Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. The device is used singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The Altus Spine Interbody Standalone Fusion System implants are made of Polyetheretherketone (PEEK) with Tantalum that conforms to ASTM 2026 and ASTM 560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The Altus Spine Interbody Standalone Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is the sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The anterior superior and inferior surface of the interbody has holes to accept screw to penetrate the intervertebral body endplates for added stability.
This document is a 510(k) Premarket Notification for a medical device called the "Altus Spine Interbody Standalone Fusion System." It outlines the device's indications for use, its description, and a comparison to predicate devices to demonstrate substantial equivalence.
However, the provided text does not contain any information regarding acceptance criteria for an AI-powered device, nor does it describe a study proving an AI device meets such criteria.
The document is for a traditional medical device (an intervertebral body fusion device) made of PEEK, Tantalum, and Titanium Alloy. The "Summary of Non-Clinical Tests Submitted" section mentions tests in accordance with ASTM standards (F2077-14, F2267-04, and ASTM Draft Std. F04.25.20.02) to demonstrate substantial equivalence to previously cleared integrated ALIFs. These are engineering and mechanical tests for a physical implant, not performance metrics for an AI algorithm.
Therefore, I cannot fulfill your request as the provided input does not contain the necessary information about an AI device's acceptance criteria or 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.