(41 days)
The SECULOK™ ACP System is intended for anterior 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:
O 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
The SECULOK™ ACP System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws 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. All implants are single use only.
This document is a 510(k) premarket notification for the SECULOK™ ACP System, a spinal intervertebral body fixation orthosis. The request asks for details on acceptance criteria and study data for a medical device. However, the provided document describes a physical medical device (spinal fixation system) and not a software or AI-driven device that would typically have performance metrics like sensitivity, specificity, or AUC. The "performance testing" described refers to mechanical bench testing, not clinical performance or AI algorithm performance.
Therefore, many of the requested points are not applicable to the nature of this submission. Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Static compression bending (ASTM F1717) | Met acceptance criteria |
| Static torsion (ASTM F1717) | Met acceptance criteria |
| Compression bending fatigue (ASTM F1717) | Met acceptance criteria |
| Substantial Equivalence to Predicate Device | Established (ASPIRON™ ACP System) |
2. Sample size used for the test set and the data provenance
Not applicable. This was mechanical bench testing, not a study involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is based on engineered specifications and industry standards (ASTM F1717).
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical device, not an AI or software product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used
For the mechanical performance tests, the "ground truth" is defined by the technical specifications and acceptance limits set by the ASTM F1717 standard for spinal implant testing and comparison to the predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
Summary of Study:
The study referenced is a series of non-clinical bench tests conducted on the SECULOK™ ACP System to assess its mechanical performance.
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Tests Performed:
- Static compression bending test according to ASTM F1717
- Static torsion test according to ASTM F1717
- Compression bending fatigue test according to ASTM F1717
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Purpose: To demonstrate that the device met established acceptance criteria and that its performance is substantially equivalent to the predicate devices (ASPIRON™ ACP System, K131200, K140234).
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Conclusion: "All tests met all acceptance criteria and that verifies performance of the SECULOK™ ACP System is substantially equivalent to predicate devices."
§ 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.