(100 days)
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.
These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.
Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.
The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).
The provided text describes a medical device, the "Unison®-C Anterior Cervical Fixation System," and its clearance by the FDA. However, it does not detail a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance (mechanical testing) rather than clinical studies or performance against specific AI/ML criteria. Therefore, most of the requested information regarding AI/ML device performance and ground truth establishment cannot be extracted from this document.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Performance) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Static axial compression (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static compressive shear (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static torsion (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Static Subsidence (per ASTM F2267-04) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic axial compression fatigue (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic compressive shear (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Dynamic torsion (per ASTM F2077-14) | Testing performed. Results deemed substantially equivalent to predicate system. |
| Locking mechanism disassociation testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Screw push-out | Testing performed. Results deemed substantially equivalent to predicate system. |
| Screw-interbody torque-to-failure testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Locking mechanism torque-to-failure testing | Testing performed. Results deemed substantially equivalent to predicate system. |
| Pyrogenicity (endotoxin level) | Evaluated using LAL assay. Device will be tested to ensure endotoxin level meets requirements ( |
§ 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.