(218 days)
When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.
When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The lumbar device is intended to be used in patients who have had six months of non-operative treatment.
When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body. resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.
The Aleutian IBF System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.
Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.
This is a 510(k) premarket notification for a medical device, not a study evaluating device performance against acceptance criteria using AI or machine learning. Therefore, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable or available in the provided document.
The document describes the Aleutian IBF System, an intervertebral body fusion device, and seeks to demonstrate its substantial equivalence to previously cleared predicate devices. The review process for 510(k) submissions relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study with specific acceptance criteria that an AI or machine learning model would typically be held to.
Here's a breakdown of why the requested information is not present:
- Acceptance Criteria & Reported Device Performance: In a 510(k), the "acceptance criteria" are usually satisfied by demonstrating substantial equivalence to a predicate device through comparison of technological characteristics, materials, and intended use. Performance is typically established by showing that the new device is functionally similar to the predicate. No specific numerical performance metrics with acceptance thresholds are provided, as would be expected for an AI study.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are central to studies validating AI/ML algorithms, where statistical rigor is applied to evaluate a model's diagnostic or predictive accuracy. The provided document is a regulatory submission for a physical implantable device, relying on the established safety and efficacy of similar existing devices. It does not involve any AI/ML components or a study of performance in the way described.
In summary, the provided text is a 510(k) summary for a physical medical device and does not contain the type of study data and analysis requested for an AI/ML-based device evaluation.
§ 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.