(91 days)
The Endoskeleton® TAS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.
The Endoskeleton TAS is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. All implantable
This is a 510(k) summary for a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML algorithms, are not present in this document.
The document describes the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, which is the standard pathway for 510(k) clearance for conventional medical devices.
I cannot provide the requested information based on the input text because it describes a traditional medical device (intervertebral body fusion device), not an AI-powered diagnostic or predictive algorithm. There are no mentions of "acceptance criteria" for algorithm performance, "test sets," "training sets," "ground truth," "experts for ground truth," or "multi-reader multi-case studies" in the context of AI evaluation.
The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence to legally marketed predicate devices, which typically involves comparing technological characteristics, intended use, and performance data (like mechanical testing, biocompatibility, etc.) relevant to the physical implant, rather than a clinical study evaluating diagnostic accuracy or AI performance.
§ 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.