(340 days)
UNiD Patient-matched PLIF cage is indicated for lumbar spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I Spondylolisthesis or Retrolisthesis at the involved level(s). This device is to be used with bone graff.
UNiD Patient-matched PLIF cage is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The UNiD patient-matched PLIF cage is an intervertebral lumbar device, designed to match the anatomy of an individual patient from patient imaging data (X-Ray, MRI, CT). The implant is manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
This looks like a 510(k) summary for a medical device called "UNiD Patient-matched PLIF cage". The provided text describes the device, its intended use, and compares it to predicate devices. It also mentions non-clinical testing but explicitly states that no clinical studies were performed.
Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria in the way you've requested, as this submission indicates clinical performance data is not available. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
If you have a different document that details clinical studies and acceptance criteria, please provide that. Otherwise, based only on the provided text, the answer is that no such study was performed to demonstrate performance against 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.