(85 days)
The IdentiTi™ Cervical Standalone Interbody System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of non-operative treatment with the device. The IdentiTi Cervical Standalone Interbody System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or cortico-cancellous bone and implanted via an open, anterior approach. The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided and requires no additional fixation.
The IdentiTill Cervical (IdentiTi-C) Standalone Interbody System is an integrated intervertebral body fusion device for use in Anterior Cervical Discectomy and Fusion (ACDF) Procedures. The IdentiTi Cervical Standalone Interbody System consists of integrated interbody spacers and bone screws in multiple configurations to accommodate individual patient anatomy.
The IdentiTi Cervical Standalone Interbody System interbody spacers are manufactured from a combination of commercially pure porous titanium (CP Ti Grade 2) per ASTM F67 and titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The IdentiTi Cervical Standalone Interbody System interbody spacers are provided in multiple footprints with varying lengths, widths, heights, and angles of lordosis to accommodate individual patient anatomy.
The anterior face of the interbody spacer includes two screw holes to accept two bone screws that are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F136 in varying lengths and diameters. All interbody spacers feature an internal graft aperture for placement of graft material to promote fusion through the cage.
The subject interbody spacers are provided individually packed and sterile. The subject bone screws are provided non-sterile to be cleaned and steam-sterilized by the end user.
The system provides reusable instruments that support varying surgical techniques, common with the ACDF approach, and are made of stainless steel and other materials. They are provided non-sterile to be cleaned and sterilized by the end user.
The provided document is a 510(k) summary for a medical device (IdentiTi™ Cervical Standalone Interbody System). It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria related to AI or diagnostic performance.
The "PERFORMANCE DATA" section explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This indicates that no clinical studies were performed to assess the performance of this specific interbody system against clinical acceptance criteria. The performance data listed (ASTM F2077, F1877, F1714, F2267, F-04.25.02.02, and Static screw push-out) are non-clinical (mechanical and material) tests for substantial equivalence, not clinical performance studies with acceptance criteria as requested in the prompt.
Therefore, I cannot provide the requested information based on the given text.
§ 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.