(129 days)
The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an 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 Pro-Link® Ti Barbs Cervical Spacer System is to be used with autogenous bone graft and implanted via an anterior approach.
The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is an interbody fusion device intended to be used with two (2) titanium bone barbs. The Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screw).
The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System is offered in various device configurations based on surgical approach and patient anatomy. The Pro-Link® Ti Barbs Cervical Spacer System includes an interbody, containing a titanium alloy locking mechanism, which is implanted with two (2) titanium bone barbs. The interbody is offered in either PEEK (Polyetheretherketone) or in titanium alloy (Ti 6Al-4V ELI). The Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System must be used with supplemental fixation (e.g., anterior plate, posterior cervical screws).
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System components with components from any other system or manufacturer. The Pro-Link® Ti Barbs Cervical Spacer System components should never be reused under any circumstances.
I apologize, but the provided text from the FDA 510(k) clearance letter and related documents for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System does not contain information about acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices (such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies).
The document is a clearance letter for a traditional orthopedic implant (intervertebral body fusion device), not a software or AI-driven device. Therefore, it focuses on demonstrating substantial equivalence to predicate physical devices based on design, materials, indications for use, and performance, primarily through a comparison of physical and mechanical properties, not through clinical or reader studies that would generate the types of data you are asking for.
The relevant sections of your request (2 through 9) are specific to the evaluation of AI/ML software devices, which are not applicable to the information provided in this document.
§ 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.