(85 days)
The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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.
WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. The system consists of a variety of bone plates and screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set of instruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTM F899. The system components are provided non-sterile and must be steam sterilized by the user prior to use.
Here's a breakdown of the acceptance criteria and study information for the ChoiceSpine Boomerang™ Anterior Cervical Plate System based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary indicates that mechanical testing was performed according to ASTM F1717-18. While specific numerical acceptance criteria (e.g., maximum deflection, fatigue cycles) are not detailed in the provided text, the summary states:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Pre-defined acceptance criteria were met. | The test results indicate that the pre-defined acceptance criteria were met. |
| Substantially equivalent to predicate devices based on mechanical testing. | Demonstrated substantial equivalence to predicate devices. |
Missing Information: The document states "pre-defined acceptance criteria were met" but does not specify what those criteria are (e.g., specific load tolerances, cycles to failure, deflection limits per ASTM F1717-18). To fully answer this, one would need to consult the full ASTM F1717-18 standard and the original test report.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "mechanical testing" was performed but does not quantify the number of plates or screws tested.
- Data Provenance: Not specified. Mechanical testing is typically conducted in a laboratory setting, not with human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device submission. Mechanical testing of an implantable device does not typically involve human experts to establish "ground truth" in the same way clinical studies or diagnostic AI algorithms do. The "ground truth" here is the physical performance and material properties of the device as measured by engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing outcomes are typically measured directly by equipment and analyzed by engineers, not adjudicated by experts in a consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices with human readers, not for spinal implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the device itself performing according to its design specifications through mechanical tests, without human interaction influencing the performance of the device itself. There is no algorithm being tested in this context.
7. The Type of Ground Truth Used
The ground truth used for this submission is mechanical performance data according to a recognized standard (ASTM F1717-18). This includes measurements of static and dynamic compression bending and static torsion, compared against design specifications and predicate device performance.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
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.