(21 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:
· 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 the posterior elements (nedicles) of the cervical, thoracic or lumbar spine.
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-6AI-4V ELI) in accordance with ASTM F136. All implants are single use only. The width of plates of to the proposed SECULOK™ ACP System was modified compared to the prior devices (K182055).
This document is a 510(k) summary for the SECULOK™ ACP System, a spinal intervertebral body fixation orthosis. It describes the device and its indications for use, and it demonstrates substantial equivalence to predicate devices based on non-clinical (bench) testing.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (from Predicate Device K182055) | Reported Device Performance (SECULOK™ ACP System) |
|---|---|---|
| Static compression bending test | Meets acceptance criteria of prior devices (K182055) | Met the acceptance criteria of the predicate devices (K182055). |
| Static torsion test | Meets acceptance criteria of prior devices (K182055) | Met the acceptance criteria of the predicate devices (K182055). |
| Compression bending fatigue test | Meets acceptance criteria of prior devices (K182055) | Met the acceptance criteria of the predicate devices (K182055). |
Note: The document explicitly states that the acceptance criteria for the SECULOK™ ACP System were "the acceptance criteria of the prior devices (K182055)." However, the specific quantitative values for these criteria are not provided in this document. It only states that the device met these unstated criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for the Test Set: Not explicitly stated. The document refers to "the proposed devices" and "the data of the proposed devices," implying that multiple devices were tested for each performance evaluation. However, the exact number of units tested per test type is not provided.
- Data Provenance: The testing was "non-clinical setting (bench testing)." No information about country of origin of data in terms of patient data is relevant as it's bench testing. It's prospective in the sense that the testing was performed specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This question is not applicable as the study involved bench testing (mechanical performance evaluation of a physical device), not an evaluation of diagnostic accuracy or clinical outcomes requiring expert interpretation of medical data. Therefore, there was no "ground truth" established by experts in this context.
4. Adjudication Method for the Test Set:
- This question is not applicable for the same reason as point 3. Bench testing results are typically quantitative measurements against defined engineering specifications, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The presented study is a non-clinical (bench) performance evaluation of the device itself, not an assessment of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. The device (SECULOK™ ACP System) is a physical spinal fixation system, not a software algorithm or an AI-powered diagnostic tool. Therefore, a "standalone algorithm performance" study is irrelevant to this device.
7. The Type of Ground Truth Used:
- The "ground truth" in this context refers to the established mechanical performance specifications and safety profiles derived from recognized industry standards (ASTM F1717) and the prior predicate device (K182055). The performance of the new device was compared against these pre-defined, acceptable mechanical limits and characteristics.
8. The Sample Size for the Training Set:
- This question is not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no training set for this type of device.
§ 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.