(29 days)
The Duo™ Expandable Interbody Fusion System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Duo Expandable Interbody Fusion System is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum or OsteoSync™ titanium, titanium alloy, and PET. The Duo implant is available in varying lengths, widths, heights, lordotic angles and is provided sterile. The implant is designed with a porous central cavity for graft containment, a rounded nose to aid in implant insertion, and rigid teeth to resist migration.
This document (K210155) is a 510(k) premarket notification for a medical device called the "Duo™ Expandable Interbody Fusion System," specifically a line extension of implants and implant trials. It describes the device, its intended use, and non-clinical testing performed to demonstrate substantial equivalence to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance results against those criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies generally associated with AI/ML-based medical devices or diagnostic tools.
The document primarily focuses on demonstrating mechanical and performance equivalence through benchtop ASTM testing for an intervertebral body fusion device, which is a physical implant, not a software or AI/ML diagnostic tool. Therefore, the requested information about AI/ML performance metrics, expert reviews, and data provenance typical for software validation studies is not applicable to this submission.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria for an AI/ML device, as this device is a physical implant and the testing described is related to its mechanical and material properties.
If there's an assumption that this is an AI/ML device based on the prompt structure, that assumption is incorrect when applied to the provided content. The document describes a traditional medical device submission for a spinal implant.
§ 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.