(266 days)
When used as a lumbar intervertebral body fusion device, the Zyston Strut Open Titanium Interbody Spacer System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Zyston Strut Open Titanium Interbody Spacer System is to be implanted via a posterior approach and is to be combined with supplemental fixation. The titanium fusion devices are not indicated for vertebral body replacement.
The Zyston Strut Open Titanium Spacer System implants are intervertebral body fusion devices consisting of a rectangular or semi-rectangular shape and various heights and footprints. The devices have an open central area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The implants are available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The implants are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F2924. The Zyston Strut Open Titanium Spacer System implants incorporate lordotic angles of 0 and 10 degrees. The implants are available in 7 to 16mm heights, 10 and 11mm widths, and 21 to 38mm lengths depending on the implant configuration. The Zyston Strut Open Titanium Spacer System implants are intended to be provided sterile.
This document describes the Zyston Strut Open Titanium Spacer System and its FDA 510(k) clearance, asserting its substantial equivalence to predicate devices. However, it does not contain information related to a study that proves the device meets acceptance criteria for a diagnostic AI/imaging device.
The provided text describes a medical device for spinal fusion, which is a physical implant. The "acceptance criteria" and "study" mentioned in the prompt are typical for AI/ML-based diagnostic devices that process imaging or other data to provide a medical assessment. This document focuses on the mechanical and biological safety and efficacy of an implantable hardware device.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document discusses:
- Trade/Device Name: Zyston Strut Open Titanium Spacer System
- Regulation Name: Intervertebral Body Fusion Device
- Regulatory Class: Class II
- Product Code: MAX
- Intended Use/Indications for Use: Spinal fusion procedures for degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1.
- Device Description: Implants made of titanium alloy (Ti-6Al-4V ELI) with various sizes and configurations.
- Performance Data: Mechanical testing (ASTM F2077, ASTM F2267) and bacterial endotoxin testing (LAL) to demonstrate substantial equivalence to predicate devices.
- Substantial Equivalence: Comparison to predicate devices (K143258, K162262, K153695) in terms of intended use, indications, technological characteristics, and principles of operation.
All these points relate to the physical implant, its material properties, and its mechanical performance, not to an AI or imaging diagnostic study.
§ 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.