(182 days)
The Pioneer IBF device systems are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with supplemental spinal fixation cleared for the implanted level, such as the Quantum, LowTop or SlimFuse systems.
The Cervical IBF device is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Lumbar IBF device system is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
The Pioneer Intervertebral Body Fusion device system is a radiolucent interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It is designed for use with supplemental internal fixation to provide structural stability in skeletally mature individuals.
The provided 510(k) summary for the "Pioneer Intervertebral Body Fusion System" (K073177) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
This 510(k) submission is for a physical orthopedic implant (intervertebral body fusion device), not a software or AI/ML device. Therefore, the details requested in the prompt regarding AI/ML device validation (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.
The "Basis of Substantial Equivalence" section states: "Documentation was provided which demonstrated the Pioneer Intervertebral Body Fusion system to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture."
This indicates that the device's acceptance was based on demonstrating substantial equivalence to predicate devices already on the market, likely through bench testing for mechanical properties, biocompatibility testing, and comparison of design and materials, rather than clinical performance metrics in the way an AI/ML device would be evaluated.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and studies for an AI/ML device based on the provided text. The information is not present because the device is not an AI/ML product.
§ 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.