(108 days)
The Pioneer SlimFuse Anterior Cervical Plating System is intended for anterior cervical fixation as an adjunct to cervical fusion for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Pioneer SlimFuse Anterior Cervical Plating System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Below is an analysis of the provided FDA 510(k) summary for the Pioneer SlimFuse Anterior Cervical Plating System.
Acceptance Criteria and Device Performance
This 510(k) submission is for a spinal intervertebral body fixation orthosis, which is a mechanical device. The acceptance criteria and performance data for such devices typically focus on mechanical properties and material conformance rather than diagnostic accuracy as would be found in AI/ML medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Testing per recognized ASTM standards (e.g., for strength, fatigue, static/dynamic limits) | "Testing per recognized ASTM standards was presented." (Specific ASTM standards and numerical results are not detailed in this summary, but would have been provided in the full submission). |
| Material Conformance | Conformance to ASTM Standard Specifications for Ti 6A1 4V ELI (e.g., chemical composition, mechanical properties) | "Materials (Ti 6A1 4V ELI) used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications." |
| Substantial Equivalence | Comparison of device performance data, materials, indications, and design/function to legally marketed predicate devices. | "Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) summary. This device is a mechanical implant, not an AI/ML diagnostic or prognostic tool that processes data from a test set of patient cases. The "test set" here refers to the actual physical components of the device undergoing mechanical testing. The provenance of these test samples would typically be the manufacturing batch from Pioneer Surgical Technology.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for a mechanical device is established through physical and material testing against established engineering standards (ASTM standards in this case), not through expert consensus on clinical cases or diagnoses. The "experts" involved would be engineers and material scientists interpreting the test results, rather than medical experts establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human readers or expert panels, usually for diagnostic accuracy studies. For mechanical device testing, the results are typically objectively measured against pre-defined engineering specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. As this is a mechanical implant, such a study design is not appropriate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study as described is not applicable. This concept applies to AI algorithms that can perform a task (e.g., detect a disease) independently. The Pioneer SlimFuse system is a physical surgical implant, not an algorithm. Its "performance" is its mechanical integrity and biocompatibility.
7. The Type of Ground Truth Used
For this mechanical device, the ground truth or reference standard is:
- Established ASTM (American Society for Testing and Materials) Standards: These provide the objective benchmarks for material composition (e.g., Ti 6A1 4V ELI) and mechanical performance (e.g., strength, fatigue life, static/dynamic limits).
- Predicate Device Data: The performance data of legally marketed predicate devices serves as a common reference point for demonstrating substantial equivalence. The "Acceptance Criteria" for substantial equivalence is that the device performs as well as or better than the predicate device for its intended use, or that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. The concept of "training set" refers to data used to train an AI/ML model. For a mechanical device, there is no AI/ML model to train. The development and design of the device would be based on engineering principles and existing knowledge, not a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons mentioned in point 8.
§ 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.