(30 days)
The Synthes Zero-P VA is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer component of the Synthes Zero-P VA should be packed with autogenous bone graft and implanted via an anterior approach.
The Synthes Zero-P VA is a radiolucent and radiopaque intervertebral body fusion device. The Synthes Zero-P VA is composed of a spacer made from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with a single posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque marker. The marker allows accurate intra-operative radiographic assessment of the position of the implant. The spacer component is preassembled with a mating titanium alloy (Ti-6Al-7Nb: TAN; ASTM F1295) interbody plate. The device is implanted anteriorly by inserting two screws (TAN) through the plate, one screw per vertebral body. The interbody plate incorporates a lock-catch mechanism in each screw hole comprised of a TAV lock-screw and catch, as well as an Elgiloy (ASTM F1058) spring. The screws offered with the Zero-P VA system are 3.7mm in diameter and are currently offered non-sterile. This line extension covers the addition of sterile-packed screws.
The provided document is a 510(k) summary for the Synthes Zero-P VA device, specifically for an extension covering sterile-packed screws. It describes the device, its intended use, and its equivalence to predicate devices. However, this document states that "Non-clinical performance data and conclusions were not needed for this device" and "Clinical data and conclusions were not needed for this device."
Therefore, the information required to answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this document. This 510(k) relies on demonstrating substantial equivalence to previously cleared predicate devices without requiring new performance studies for this specific modification (sterile-packed screws).
To fully answer your questions, one would need to refer to the performance data and studies conducted for the original Synthes Zero-P VA device (K112068) and its earlier versions (K093762, K112459), or if such studies were performed for those previous clearances. This document explicitly states that no new performance data was needed for this particular 510(k) submission.
§ 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.