(59 days)
The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.
EIT Cellular Titanium® LLIF Cage
The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. 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 or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The CONDUIT™ Lateral Angled Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.
The provided text describes the DePuy CONDUIT™ LLIF Angled Inserters, an intervertebral body fusion device tool. However, it does not include information about acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.
The document is a 510(k) summary for a medical device (a surgical tool), not an AI/ML diagnostic or prognostic device. As such, the typical metrics and study designs (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) for AI evaluation are not applicable or discussed here.
Instead, the performance data section states: "Non-clinical testing was conducted to confirm device performance per intended use including functionality bench test, impact endurance test, thread endurance test, and formative usability test. The results of this non-clinical testing show that the performance of the DePuy CONDUIT™ LLIF Angled Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
This indicates that the device's performance was evaluated through bench testing for physical properties and functionality, not through clinical studies involving patient data or AI algorithm performance metrics.
Therefore, I cannot provide the requested information in the structured format because the document does not contain data related to AI/ML device acceptance criteria and studies.
§ 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.