(104 days)
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 autogenous bone graft 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 of autogenous bone graft 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 non-sterile and intended for SINGLE USE ONLY 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.
I'm sorry, but the provided text from the FDA 510(k) notification for the ProLift® Expandable System does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or a "human-in-the-loop" performance study.
This document is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented in this document (Static compression, dynamic compression, static and dynamic shear testing according to ASTM F2077, as well as subsidence according to ASTM F2267) are mechanical performance tests of the physical implant itself, not a study of an AI algorithm or human reader performance.
Therefore, I cannot populate the requested table and answer the questions about AI performance, test sets, expert consensus, or MRMC studies based on the provided text.
The closest relevant information is that the device is a physical medical device (an intervertebral body fusion device), not an AI/software device. The "performance data" section refers to mechanical tests of the implant, not clinical or AI algorithm performance.
§ 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.