(98 days)
The Amendia Stand-Alone Cervical System 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 Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.
The Amendia Stand-Alone Cervical System includes a PEEK spacer component (medical grade Zeniva ZA-500, ASTM F2026) with Tantalum markers (ASTM F560), and a titanium interbody plate and screws (ASTM F136). The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
Based on the provided document, the device in question is the "Amendia Stand-Alone Cervical System," which is an intervertebral body fusion device. The document is a 510(k) premarket notification of intent to market, issued by the FDA.
Crucially, this document is a 510(k) clearance based on substantial equivalence to a predicate device, not an approval based on a clinical study demonstrating performance against acceptance criteria.
Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found or inferred from this document.
Here's why:
- 510(k) Process: The 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device. This often relies on comparative testing (e.g., mechanical, material) to show that the new device performs as safely and effectively as the predicate, rather than new clinical trials establishing efficacy against specific performance metrics in human patients.
- "Performance testing was not necessary": The document explicitly states: "Performance testing was not necessary since the Subject and Predicate Devices are identical with regards to intended use, indications for use, materials, manufacturing processes, and performance specifications." This means no new "performance testing" (which would include clinical studies generating the data you're asking about) was conducted for this specific 510(k) submission to demonstrate the device meets acceptance criteria derived from clinical outcomes.
Given this, I cannot provide the requested information about acceptance criteria or a study that proves the device meets those criteria from this document. The document indicates that no such study was performed or required for this particular 510(k) clearance due to the device's substantial equivalence to an already cleared predicate.
If this were a PMA (Premarket Approval) or a device requiring new clinical data, the submission would contain the detailed study information you are asking for.
Therefore, I will state that the requested information is not available in the provided document, as a clinical study proving performance against acceptance criteria was not conducted for this 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.