(124 days)
The ASPIRON™ ACP System is intended for anterior inter-vertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- · Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration disc confirmed by patient history and radiographic studies);
- · Spondylolisthesis
- · Trauma (including fractures, dislocation)
- · Spinal stenosis
- · Tumors
- · Deformity (defined as scoliosis, kyphosis, or lordosis)
- · Pseudoarthrosis
- · Failed previous fusion
WARNING: The device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine,
The ASPIRON™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws i inserted into the vertebral body of the cervical spine using an anterior approach. All implant components are made from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. The main plate and screws are anodized according to the internal process (5% Phospheric acid solution under pH 1.5). The same anodizing process is also applied to the conventional ASPIRON™ ACP System(K131200) and Maxima(K061002). This material is not compatible with other metal alloys. Stainless steel and titanium implant components should not be used together in a construct. Do not use any of the ASPIRON™ ACP System components with the components from any other system or manufacturer. All implants are single use only. The Type 2 of screws and short plates are added to the conventional ASPIRON™ ACP System in this submission. Type 2 screw has thread until the tip of screw for easy insertion.
This submission describes the ASPIRON™ ACP System, an anterior cervical plate system used for temporary stabilization of the anterior spine during cervical spine fusions. The submission seeks to expand the existing system (K131200) to include shorter plate sizes and new types of bone screws.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a non-clinical (bench testing) study to assess the mechanical performance of the ASPIRON™ ACP System.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of ASPIRON™ ACP System met the acceptance criteria established from predicate devices. | The compression bending fatigue test was performed according to ASTM F1717, and the testing met all acceptance criteria. This verifies that the performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the mechanical performance test. It mentions that "The ASPIRON™ ACP System was tested," indicating that the newly designed components (shorter plates and new screw types) were subjected to testing.
- Data Provenance: The study was a non-clinical (bench testing) study conducted by the manufacturer, U & I Corporation, located in Gyeonggi-do, Korea. The data is prospective in the sense that it was generated for this specific submission to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical mechanical performance study (bench testing), not a study involving human subjects or expert assessment of clinical outcomes or images. The "ground truth" was established by adherence to a standardized testing method (ASTM F1717) and pre-defined acceptance criteria based on predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench testing study, there was no need for adjudication by experts in the context of human data interpretation. The results of the mechanical tests are quantitative and objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical performance of a medical device (spinal intervertebral body fixation orthosis) and does not involve human readers interpreting images or clinical data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant (anterior cervical plate system), not a software algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this study was based on bench testing against established standards and predicate device performance.
- The primary standard mentioned is ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) for compression bending fatigue testing.
- The device's performance was also compared against the acceptance criteria established from predicate devices (e.g., Maxima™ Anterior Cervical Plate System, Blackstone™ III° Anterior Cervical Plating System).
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.