(82 days)
When used as an interbody fusion device, the ProLift® Expandable System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The ProLift® Expandable System is available in a range of sizes and footprints and can expand to the desired height (8mm to 16mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONL Y and should not be reused under any circumstances. Do not use any of the ProLift® Expandable System components with components from any other system or manufacturer. The ProLift® Expandable System components should never be reused under any circumstances.
The provided document is a 510(k) premarket notification for a medical device called the ProLift® Expandable System, an intervertebral body fusion device. This type of regulatory filing focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving efficacy or safety through clinical trials with defined acceptance criteria for a device's performance.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth establishment relevant to AI/algorithm performance.
Instead, the "Performance Data" section (page 4) refers to:
- Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077. This is mechanical testing to demonstrate the structural integrity and equivalence of the device to predicate devices, not performance related to clinical outcomes or diagnostic accuracy for an AI system.
The document explicitly states: "The ProLift® Expandable System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." This underlines that the focus is on equivalence in physical and mechanical properties and intended use, not on a performance study comparing diagnostic accuracy or clinical effectiveness against specific acceptance criteria.
§ 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.