(49 days)
The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone to facilitate fusion and are implanted via a posterolateral approach.
The EARP Interbody System is an intervertebral body fusion device used in the lumbar spine following discectomy. All devices are manufactured from PEEK OPTIMA® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radio-graphic visualization.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.
The provided text is a 510(k) summary for the EARP Interbody System, which is a medical device for spinal fusion. It details the device's indications for use, technological comparisons to predicate devices, and a summary of non-clinical tests. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, study details (sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used.
Therefore, I cannot provide the requested information from the given text. The document states that "Analysis of the subject device modifications verified that they would not impact function or performance" and "the analysis supported the conclusion that the subject EARP Interbody System is substantially equivalent to the predicates," but it does not provide the concrete data or study specifics you're asking for.
§ 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.