(96 days)
The PERIMETER® C Spinal System is intended to be used for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc who have had six weeks of non-operative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.
The PERIMETER® C (Titanium) Spinal System consists of spacers/cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.
The purpose of this submission is to include additional interbody cages manufactured from medical grade titanium alloy (Ti-6A1-4V ELI) that are packaged sterile via gamma irradiation.
The provided document is a 510(k) premarket notification for a medical device called the PERIMETER® C (Titanium) Spinal System. This document does not describe an AI/ML device or a study that evaluates its performance against acceptance criteria in the way described in the prompt.
Instead, this document is for a traditional medical implant (intervertebral body fusion device) and focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The performance data discussed here relates to biocompatibility and mechanical testing of the physical implant, not the performance of an algorithm or AI system.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves an AI device meets them. The prompt's questions pertain to AI/ML device evaluations (e.g., sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance), which are not present in this physical medical device's 510(k) submission.
In summary, the provided text does not contain the information requested in your prompt as it is not about an AI/ML device.
§ 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.