(80 days)
The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.
The Cure™ OPEL-C (T) and Cure™ OPEL-C (S) are available in a range of lengths to coincide with the surgical approach and screws that are available in multiple lengths and diameters. The Cure™ OPEL-C Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
This document is a 510(k) premarket notification for a spinal implant. It describes the device, its intended use, and its equivalence to a predicate device. The information provided heavily focuses on regulatory approval based on substantial equivalence through non-clinical mechanical testing, rather than a clinical study involving human performance or diagnostic accuracy.
Therefore, many of the requested criteria related to a clinical study (like stand-alone performance, MRMC studies, sample sizes for training/test sets, ground truth establishment for clinical data, expert qualifications, and adjudication methods for clinical data) are not applicable or not present in this type of submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Reported Device Performance
Since this is a mechanical device cleared based on substantial equivalence through non-clinical testing, the "acceptance criteria" revolve around demonstrating comparable or superior mechanical performance to the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Mechanical Testing) | Reported Device Performance (Cure™ OPEL-C Plate System) |
|---|---|
| Demonstrate equivalency to the previously tested predicate device with respect to: | Superior in mechanical function to the predicate device. |
| Static compression bending (per ASTM F1717) | Met and exceeded equivalency. |
| Static tension (per ASTM F1717) | Met and exceeded equivalency. |
| Dynamic compression bending (per ASTM F1717) | Met and exceeded equivalency. |
Study that Proves the Device Meets Acceptance Criteria
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set from human data for this type of submission. The "test set" here refers to mechanical test samples, not patient data. The document does not specify the number of mechanical samples tested, but it states that "An engineering analysis was performed."
- Data Provenance: Not applicable for clinical data. The data provenance is from laboratory mechanical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for a mechanical device is established through calibrated measurement instruments and adherence to standardized testing protocols (ASTM F1717) in an engineering laboratory. No human experts are involved in establishing a "ground truth" for mechanical function in the way they would for, say, image interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image analysis or diagnosis. Mechanical testing results are objective measurements.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This device is a mechanical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm) performance study was not done. This is a mechanical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective mechanical properties and performance standards as defined by ASTM F1717 and compared to a predicate device. It's not based on expert consensus, pathology, or outcomes data in the clinical sense.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set."
Summary of Relevant Information from the Document:
- Device Type: Spinal implant (Cure™ OPEL-C Plate System).
- Regulatory Path: 510(k) Premarket Notification based on Substantial Equivalence.
- Key Evidence for Substantial Equivalence: Non-clinical Mechanical Testing (engineering analysis) performed according to ASTM F1717.
- Comparison: The device was shown to be "superior in mechanical function to the predicate device" (K160604, Cure™ Anterior Cervical Plate System) in static compression bending, static tension, and dynamic compression bending.
- Differences from Predicate: Exclusive to the posterior side for interface with interbodies, absence of graft windows, increased maximum screw angulation, and decreased axial radius. However, "fundamental technological characteristics" and central locking mechanism are identical.
§ 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.