(89 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 or horseshoe-shaped structures 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 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.
The provided text describes a 510(k) summary for the Aleutian IBF System, which is an intervertebral body fusion device. The focus of the document is on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technological characteristics and preclinical testing.
Based on the information provided, here's an analysis of the acceptance criteria and study as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Equivalence | Demonstrated through Finite Element Analysis (validated by static compression and static torsion testing per ASTM F2077) to show that added components would not result in a new worst-case device. |
| Material Equivalence | Devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads/rods are Grade UNS R05200, UNS R05400 according to ASTM F560, consistent with accepted medical device materials. |
| Biocompatibility | PEEK material specified as compliant with ISO 10993-1 USP Class VI. |
| Intended Use Equivalence | Indications for use for cervical, lumbar, and vertebral body replacement applications align with existing cleared devices for similar spinal fusion and stabilization purposes. |
| Substantial Equivalence to Predicates | Documentation provided demonstrating substantial equivalence to K2M's Aleutian IBF System (K051454, K063399, K080024, K082698, K101302), DePuy AcroMed's Cougar and Bengal (K081917), and Alphatec's Novel (K080699). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission relies on preclinical testing (Finite Element Analysis and static mechanical testing) and comparison to predicate devices, not clinical patient data with a test set.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective human data. The testing described is preclinical engineering analysis and mechanical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As a preclinical mechanical evaluation, there's no "ground truth" derived from expert clinical interpretation of data in the way one would for diagnostic imaging. Expertise in biomechanical engineering and material science would have been involved in the design and interpretation of the Finite Element Analysis and mechanical testing.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) comparing human performance with and without AI assistance. This document is for an intervertebral body fusion device, which is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This concept is applicable to software or AI algorithms. The device is a physical medical implant.
7. The Type of Ground Truth Used
- For the preclinical testing mentioned (Finite Element Analysis and static compression/torsion), the "ground truth" refers to established engineering principles, material properties (e.g., ASTM F2077 standards for spinal implants), and the performance characteristics of the predicate devices. The aim was to demonstrate that the new device components do not introduce new safety or effectiveness concerns compared to these established benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no corresponding ground truth to establish for it.
In summary: The provided document is a 510(k) summary for a physical medical implant, the Aleutian IBF System. The "study" described is a preclinical engineering evaluation consisting of Finite Element Analysis validated by static compression and torsion testing. Acceptance criteria revolve around demonstrating substantial equivalence in technological characteristics (materials, design, mechanical performance) and intended use to existing legally marketed predicate devices, rather than clinical performance metrics in a patient population or AI model 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.