(122 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.
ASPIRON™ ACP System consists of a variety of shapes and size of bone plates, screws and associated instruments. All implant components are made from a titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136. ASPIRON ™ ACP System is intended to provide stabilization of the cervical vertebra for various indications. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study (K131200)
The ASPIRON™ ACP System, an anterior cervical plate system, established substantial equivalence by demonstrating mechanical performance equivalent to its predicate devices. The study involved non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Construct Test (ASTM F1717) | Performance equivalent to predicate devices (Maxima™ K061002, Blackstone™ III° K012184, ZEPHIR™ K994239) | "The mechanical performance of ASPIRON™ ACP System met the acceptance criteria which have been established from the predicate devices." |
| "The testing met all acceptance criteria and verifies that performance of the ASPIRON™ ACP System is substantially equivalent to the predicate devices." | |||
| Static compression bending | Performance equivalent to predicate devices | Met acceptance criteria, substantially equivalent to predicates | |
| Static torsion test | Performance equivalent to predicate devices | Met acceptance criteria, substantially equivalent to predicates | |
| Compression bending fatigue | Performance equivalent to predicate devices | Met acceptance criteria, substantially equivalent to predicates | |
| Torsion fatigue test | Performance equivalent to predicate devices | Met acceptance criteria, substantially equivalent to predicates | |
| Screw back out test | Performance equivalent to predicate devices | Met acceptance criteria, substantially equivalent to predicates |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for each performance test. It refers to these as non-clinical "bench testing." Typically, these tests involve multiple samples to ensure statistical validity, but the exact number is not provided in this summary.
- Data Provenance: The tests were conducted in a non-clinical setting (bench testing). No country of origin for the data is specified beyond the manufacturer being in Korea. This was a retrospective study in the sense that the device was tested against established performance criteria derived from existing predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a bench test evaluating mechanical performance against engineering standards and predicate device performance, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
Not applicable. Ground truth was established by adherence to ASTM standards and comparison to predicate device performance, not through expert adjudication of patient cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This was a bench testing study for mechanical performance, not a clinical study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical implant (anterior cervical plate system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The device's performance was evaluated inherently "standalone" in its mechanical properties.
7. The Type of Ground Truth Used
The ground truth used was:
- Adherence to recognized consensus standards (specifically ASTM F1717 for construct testing).
- Performance data from legally marketed predicate devices (Maxima™ K061002, Blackstone™ III° K012184, ZEPHIR™ K994239) as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
§ 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.