(221 days)
When used as a pedicle screw fixation system, the NuVasive Reline 4.5-5.0 System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor and/or
- Failed previous fusion (pseudoarthrosis)
The Nu Vasive Reline 4.5-5.0 System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants of a solid fusion.
When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive Reline 4.5-5.0 System is also intended for the following indications:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spinal stenosis
- Spondylolisthesis
- Spinal deformities
- Fracture
- Pseudoarthosis
- Tumor resection and/or
- Failed previous fusion
When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline 4.5-5.0 System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Nu Vasive Reline 4.5-5.0 System is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft.
In order to achieve additional levels of fixation, the NuVasive Reline 4.5-5.0 System rods may be connected to the Armada System.
The NuVasive Reline 4.5-5.0 System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. 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 design changes to the modular screws of the previously cleared Reline 4.5-5.0 System.
The provided document is a 510(k) summary for the NuVasive® Reline® 4.5-5.0 System, a medical device for spinal fixation. It outlines the device's intended use, technological characteristics, and performance data used to demonstrate substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device.
Specifically, the document discusses performance data in terms of nonclinical testing for mechanical properties, not performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy). It also does not involve human readers, ground truth establishment by experts, or training/test set sample sizes in the context of an AI/ML algorithm.
Therefore, many of the requested categories cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (implied) | The results from Dynamic Flexion-Extension Moment Testing per ASTM F1798 demonstrate substantial equivalence to the predicate. (Specific numerical criteria or performance values are not provided, only the conclusion of substantial equivalence). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The "test set" in this context refers to physical device components undergoing mechanical testing, not a dataset for an AI/ML model. The document does not specify the number of samples tested for the Dynamic Flexion-Extension Moment Testing, nor does it refer to data provenance in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. This document describes a traditional medical device (spinal hardware) and its mechanical testing, not an AI/ML device that requires expert-established ground truth from medical imaging or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are relevant for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, which is not the subject of this document.
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
- Not applicable / Not provided. This document is for a spinal fixation system, not an AI-assisted diagnostic or interpretative device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. The device is a physical pedicle screw system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The "ground truth" for this device's performance is its mechanical integrity and strength as evaluated by a standardized test (ASTM F1798) to demonstrate substantial equivalence to a predicate device. There is no biological or interpretative ground truth in the AI/ML sense.
8. The sample size for the training set
- Not applicable / Not provided. This device does not involve a training set for an AI/ML model.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This device does not involve a training set for an AI/ML model.
In summary: The provided 510(k) summary is for a physical medical device (spinal fixation system) and details its mechanical performance testing to establish substantial equivalence. It does not provide information about acceptance criteria or a study design relevant to an AI/ML medical device as implied by the detailed questions.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.