(127 days)
The DeGen Medical Impulse AM™ implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
DeGen Medical Impulse AM™ System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse AM™ system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse AM™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature porous surfaces to facilitate fusion and mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical's Impulse AM™ Spacers are additively manufactured from Puri-Ti™ unalloyed titanium.
This document is a 510(k) summary for the DeGen Medical Impulse AM™ System, an intervertebral body fusion device. It does not contain information about acceptance criteria and performances from a study related to an AI device.
The provided text describes a medical device, its indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. It specifically states: "Non-clinical testing was performed to demonstrate minor modifications in manufacturing of the subject device do not negatively impact the final device as compared to the originally cleared system in K210090." The performance tests mentioned are "Static and dynamic compression testing per ASTM F2077" and "Dynamic compression shear testing per ASTM F2077". These are engineering tests for the physical device itself, not performance metrics for an AI algorithm.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) as it pertains to AI device evaluation because this document does not describe such a device or study.
§ 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.