(89 days)
The CREO® Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and for pediatric patients. These devices are indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Schevermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When used as an adjunct to fusion, the CREO® Stabilization System is intended to be used with autograft and/or allograft.
In addition, the CREO® Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fision by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CREO® Stabilization System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The CREO® Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.
In order to achieve additional levels of fixation the CREO® Stabilization System rods may be connected to the REVERE Stabilization System (4.5mm, 5.5mm, or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® system package insert for instructions and indications of use.
In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth 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, as part of a growing rod construct.
Globus Navigation Instruments are intended to be used during the preparation and placement of CREO® screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
When used for posterior fixation in conjunction with FORTRESS-Plus™ bone cement, the CREO® Fenestrated Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CREO® Fenestrated with FORTRESS™ and FORTRESS-Plus™ bone cements are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices such as biopsy needles, electrodes, and tubes.
CREO® ONE Robotic Screws are polyaxial screws with a tapered distal awl tip to allow penetration of the cortex of the pedicle, for ease of use with the ExcelsiusGPS® robot and Globus Navigated Instruments. Implants are available in a variety of sizes to accommodate individual patient anatomy. CREO® ONE screws may be used with ExcelsiusGPS® instruments and CREO® Navigation instruments.
CREO® ONE Robotic Screws are composed of titanium alloy with optional hydroxyapatite (HA) coating.
This document describes the FDA's clearance of the CREO® ONE Robotic Screws, along with CREO® Stabilization System and Navigation Instruments, and the ExcelsiusGPS® system. However, the provided text does not contain any information about specific acceptance criteria or the study that proves the device meets those criteria in the context of human-in-the-loop performance, AI assistance, or standalone algorithm performance.
The "Performance Data" section is extremely brief and only states: "Verification and validation cadaveric testing was conducted, including planning and placement of CREO ONE screws, using the ExcelsiusGPS System and associated instruments to demonstrate that CREO ONE Robotic Screws meet performance and navigation accuracy requirements."
This summary indicates that performance and navigation accuracy requirements were met through cadaveric testing, but it does not provide details on:
- Specific acceptance criteria: What were the numerical thresholds for "performance" or "navigation accuracy"?
- Reported device performance values: What were the raw or statistical results from the cadaveric testing?
- Sample size: How many cadavers or screws were tested?
- Data provenance: Where did the cadavers come from? Was it a retrospective or prospective study?
- Experts for ground truth: Were experts involved in defining "ground truth" for navigation accuracy on cadavers? If so, how many and what were their qualifications?
- Adjudication method: How was accuracy adjudicated?
- MRMC comparative effectiveness study: No mention of human readers, AI assistance, or MRMC studies.
- Standalone algorithm performance: This is a physical device, not an AI algorithm, so this concept doesn't directly apply in the usual sense. The accuracy refers to the physical system's guidance.
- Type of ground truth: While it's cadaveric testing, the method of establishing the "true" anatomical position for comparison isn't detailed (e.g., micro-CT, physical measurement).
- Training set: This product is a medical device and navigation system, not an AI model requiring a separate "training set" in the context of machine learning. The term "training set" would not apply here.
- Ground truth for training set: Not applicable for this type of device.
Therefore, based solely on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance with the level of detail requested for an AI/algorithm-focused study. The document confirms that testing was done to demonstrate performance and navigation accuracy, but the specifics are not disclosed in this public summary.
The document is a 510(k) summary for a medical device (surgical instruments and a navigation system), not a software or AI product requiring the type of performance evaluation typically detailed in the prompt. The "performance data" here refers to the physical accuracy and functionality of the instruments and navigation system working together, likely tested in a lab or cadaveric setting against engineering specifications.
§ 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.