(52 days)
Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Spineart Juliet® Ti PO & OL spinal implants consist of a range of intervertebral body spacers with various shapes and designs so as to be implanted via an open posterior or transforaminal approach and to adapt different patient anatomy. The devices have a central cavity that can receive autogenous bone graft intended to promote intervertebral fusion. Juliet® Ti PO & OL spinal implants are all made of Titanium alloy Ti6Al4V ELI conforming to ASTM F136. The subject Juliet® Ti PO & OL spinal implants are additively manufactured and present both solid and porous structures. The subject implants Juliet® Ti OL Insert/Rotate will extend the previously cleared Juliet® Ti (PO, OL & TL) range of implants (K153621) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM). The Juliet® Ti PO & OL spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile).
The provided text pertains to a 510(k) premarket notification for a medical device called "Juliet® Ti," an intervertebral body fusion device. This document is a regulatory submission to the FDA, asserting substantial equivalence to a legally marketed predicate device.
Crucially, this document does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The text focuses on the device's design, manufacturing process (additive manufacturing), material (Titanium alloy), and non-clinical mechanical testing (e.g., static and dynamic compression, shear compression, subsidence) which were performed on the predicate device.
The key statement regarding testing for the subject device (the new Juliet® Ti OL Insert/Rotate) is: "No additional testing has been performed for the subject Spineart Juliet® Ti OL Insert/Rotate spinal implants."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as the provided document does not contain this information. The document itself states that "No additional testing has been performed for the subject Spineart Juliet® Ti OL Insert/Rotate spinal implants," relying instead on the substantial equivalence to a predicate device and testing performed on that predicate device.
§ 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.