(71 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 and older, adult scoliosis, kyphosis and spondylolisthesis;
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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 cobalt-chromium 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, and transverse processes from T1-L5. The system is comprised of braided bands and clamps designed to attach to titanium allov or cobalt-chromium allov 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 provided text is a 510(k) summary for the NuVasive® VersaTie System, a bone fixation cerclage device. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by nonclinical performance data.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly list formal "acceptance criteria" with numerical thresholds typically seen for AI/software-as-a-medical-device (SaMD) clearances (e.g., sensitivity, specificity, AUC). Instead, for this Class II mechanical device, the performance is demonstrated through biomechanical testing, compared to a predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength | Demonstrated substantial equivalence to predicate device Zimmer® Universal Clamp Spinal Fixation System (K142053) |
| Static Band Tensile Strength | Testing performed. Results demonstrated substantial equivalence. |
| Static and dynamic band pull-through | Testing performed. Results demonstrated substantial equivalence. |
| Static rod-connector axial slip | Testing performed per ASTM F1798. Results demonstrated substantial equivalence. |
| Static rod-connector axial moment | Testing performed per ASTM F1798. Results demonstrated substantial equivalence. |
| Material Composition | Equivalent to predicate device. |
| Biocompatibility | Not explicitly detailed in the summary, but implicit for implantable devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes (e.g., number of bands, clamps, or test repetitions) for each type of mechanical test. It mentions "nonclinical testing" was performed.
- Data Provenance: The data is from nonclinical (in vitro/benchtop) testing, not human patient data. There is no country of origin for the data in the context of patient cohorts, as it's a mechanical device test. The tests were performed to demonstrate substantial equivalence for regulatory submission in the USA (FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The "ground truth" for mechanical testing is established by the physical properties and performance measured during the tests, adhering to recognized standards (e.g., ASTM F1798). It does not involve human experts establishing a ground truth in the way medical imaging or diagnostic algorithms do.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for expert review of human data, typically in diagnostic or screening studies, not for biomechanical testing of a medical device.
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 (NuVasive® VersaTie System) is a physical, implantable medical device for spine fixation, not an AI or diagnostic imaging system. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable, as the device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on established biomechanical and material science principles and standards, specifically referenced ASTM F1798. The performance relative to the predicate device serves as the benchmark for "truth" in terms of substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. This is not a machine learning or AI 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.