(69 days)
The NuVasive® VersaTie™ System is a temporary implant for use in orthopedic surgery. The System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
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Spinal trauma surgery, used in sublaminar or facet wiring techniques;
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Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis; 3. Spinal degenerative surgery, as an adjunct to spinal fusions.
The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobaltchromium alloy whenever "wiring" may help secure the attachment of other implants.
The NuVasive VersaTie System is part of a spinal fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium alloy or cobalt-chromium alloy rods. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. The purpose of this submission is to introduce an additional surgical technique.
The provided text describes a 510(k) premarket notification for the NuVasive® VersaTie™ System, a temporary implant for use in orthopedic surgery. The document focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not found within this particular document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally states that the device was shown to be "substantially equivalent" to its predicate based on the nonclinical testing.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Implied: Mechanical performance (strength, durability, pull-through resistance) equivalent to predicate device. | "The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "nonclinical testing" was performed, which typically refers to mechanical or bench testing. It does not refer to a "test set" in the context of patient data or clinical studies. Therefore, information about sample size for a test set (in terms of patient data) or data provenance (country of origin, retrospective/prospective) is not applicable as this was not a clinical study involving human subjects or patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or expert review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes nonclinical (bench) testing, not a study involving human data or requiring adjudication.
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
This information is not applicable. The device is a physical bone fixation system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical bone fixation system, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing, the "ground truth" would be the engineering specifications and established mechanical properties of the predicate device. The performance of the subject device (NuVasive® VersaTie™ System) was compared against these established characteristics of the predicate to demonstrate substantial equivalence. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense.
8. The Sample Size for the Training Set
This information is not applicable. The document describes nonclinical (bench) testing of a physical device, and does not involve a training set as would be relevant for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
Summary of Study (Based on Provided Text):
The study described is a nonclinical performance study comparing the NuVasive® VersaTie™ System to a legally marketed predicate device (NuVasive VersaTie System cleared in K161265). The purpose was to demonstrate substantial equivalence for the new device.
The testing performed included:
- Static and dynamic Anterior-Posterior band pull-through testing
- Static and dynamic Caudal-Cranial band pull-through testing
Conclusion from the document: The results of this nonclinical testing demonstrated that the subject NuVasive® VersaTie™ System is substantially equivalent to the predicate. The "acceptance criteria" were implied to be performance characteristics (e.g., strength, durability, pull-through resistance) comparable to or better than the predicate device.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.