(91 days)
The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or fixation anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.
I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device called "Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device."
While it lists performance standards (ASTM F2077, ASTM F-04.25.02.02, ASTM F2267) that performance testing was completed per, it does not describe:
- Specific acceptance criteria values.
- The results of the tests against those criteria.
- Details about a study involving, for example, a test set, ground truth, expert readers, or effect sizes of human performance improvement with AI.
The document primarily focuses on the regulatory aspects of the device's clearance, including its indications for use, device description, predicate devices, and a conclusion of substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided 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.