(58 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 20mm) 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 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.
This document describes the ProLift® Expandable System, an intervertebral body fusion device, and its 510(k) clearance. However, the provided text does not contain any information regarding acceptance criteria, device performance studies (like sample size, ground truth, expert qualifications, or MRMC studies), or details about an AI/algorithm-based device.
The document is purely a regulatory submission for a physical medical device (an expandable spinal implant) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices based on design, materials, indications for use, and mechanical performance testing of the device itself, not any associated software or AI.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a study proving device performance as it relates to an AI/algorithm.
If your request was mistakenly assuming this document refers to an AI/algorithm, please clarify or provide a different document.
Based on the provided text, the closest I can get to relevant sections are:
1. A table of acceptance criteria and the reported device performance:
The document mentions mechanical performance testing. While it doesn't provide a table of acceptance criteria or specific numerical performance results, it states what tests were performed:
| Test Type | Standard | Reported Performance |
|---|---|---|
| Static compression | ASTM F2077 | Performed for substantial equivalency claim |
| Dynamic compression | ASTM F2077 | Performed for substantial equivalency claim |
| Static shear | ASTM F2077 | Performed for substantial equivalency claim |
| Subsidence | ASTM F2267 | Performed for substantial equivalency claim |
The rest of the requested information (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set information) is not present in this document as it pertains to AI/algorithm performance, not a physical implant's mechanical characteristics.
§ 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.