(106 days)
The Aleutian Spacer System is 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 of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord on and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even is the anserve of fusion for a prolonged period.
The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental fixation systems that may be used with this implant are the Denali System, Denali Deformity and Mesa Spinal system.
The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes ond heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are desired to angage 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 a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine.
The provided text is a 510(k) summary for the Aleutian Spacer System, a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study proving the device meets them as would be found in a performance study for a novel AI/software medical device.
Therefore, the requested information elements related to AI device performance evaluation (such as sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not present in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a formal performance study against such criteria. Instead, it emphasizes substantial equivalence to a predicate device. The "performance" reported is that the device is manufactured from medical-grade materials and its function is described.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material safety and biocompatibility | 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 as a vertebral body replacement device to assist in fusion | "The system functions as a partial vertebral body replacement device to assist in fusion and to provide support and stabilization of the thoraco-lumbar segments of the spine." Provides support and stabilization and restores height; designed to restore biomechanical integrity. |
| Compatibility with specified supplemental fixation systems | Intended to be used with Denali System, Denali Deformity, and Mesa Spinal system. |
| Substantial Equivalence to predicate device | No significant differences from other currently marketed systems that would adversely affect use. Substantially equivalent in design, function, material, and intended use to K051454. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a performance study for an AI/software device involving a 'test set' of data. The "study" is a demonstration of substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical implant device, not an AI diagnostic or assistance tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant device, not an AI algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for a 510(k) for a physical implant device is typically established through engineering testing, material specifications, and comparison to existing, legally marketed devices (predicate devices).
8. The sample size for the training set
Not applicable. This is not an AI/software device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.