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The NuVasive Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The growth rod conversion implants may be used with Armada, Reline 4.5-5.0 rod constructs ranging in diameter from 4.5mm to 6.35mm. The NuVasive Growth Rod Conversion Set is not intended to be used in conjunction with staples.

The NuVasive Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. Implant components are available in a variety sizes and can be rigidly locked into a variety of different rod diameters. The devices are manufactured from biocompatible medical grade titanium alloy.

The provided text is a 510(k) summary for a medical device (NuVasive® Growth Rod Conversion Set). It details the device's intended use, technological characteristics, and a comparison to predicate devices, but does not contain information regarding
acceptance criteria, specific performance claims (e.g., accuracy, sensitivity, specificity), or the details of a clinical study with human readers, ground truth establishment, or statistical analysis.

The document states:

• "No additional testing was provided to support usage for the non-fusion indication." (Page 5, Section G. Performance Data)
• "Testing previously performed for Reline System (K143684) and Reline 4.5-5.0 System (K170126) to support fusion applications included subject devices. Comparison to predicate devices indicated for growth rod conversion was performed." (Page 5, Section G. Performance Data)

This indicates that the submission relied on existing testing data for other devices (Reline System and Reline 4.5-5.0 System) that included components similar to the subject device, and a comparison to predicate devices. It does not describe a specific study conducted to prove the current device meets acceptance criteria in the way one might expect for a diagnostic or AI-powered device (e.g., performance metrics, clinical reader studies).

Therefore, it is not possible to provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies based on the provided text. The device's substantial equivalence relies on demonstrating similar technological characteristics and intended use to existing predicate devices, rather than a new clinical performance study for this specific device clearance.

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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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. 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;

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 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.

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.

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