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510(k) Data Aggregation
(124 days)
ASPIRON ACP SYSTEM
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.
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(122 days)
ASPIRON ACP SYSTEM
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."
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