(443 days)
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The proposed modified Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade Solvay Zeniva ZA-500 PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
This 510(k) summary describes a medical device, the Transcorp ACIF System, and its modifications. It does not contain information about an AI/ML device or the results of a study designed to evaluate its performance against acceptance criteria using a test set, ground truth, or expert readers.
The document describes the performance testing for a physical implantable device, not an algorithm. The relevant section states:
"Performance testing was performed on the proposed modified IBFD. Static and dynamic axial compression, static and dynamic compression shear, and static torsion testing per ASTM F2077-11 were performed. Expulsion testing was also performed on the proposed modified IBFD. Engineering analyses were conducted to evaluate the Subsidence and Wear of the proposed modified implant. No clinical testing was performed."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm.
§ 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.