(28 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, tracture 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 LS-S1 vertebra in skeletally mature patients receiving fusion 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. Pediatic 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®, or ELLIPSE® 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 Medtronic 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.
Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (OUARTEX®, 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 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 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 the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures 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.
CREO® Preferred Angle Screws are polyaxial screws with a preferred angle in one direction. They are composed of titanium alloy or cobalt chrome molybdenum alloy as specified in ASTM F136 and F1537, and are available with optional hydroxyapatite (HA) coating per ASTM F1185.
Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill that are intended to be used with the Medtronic StealthStation® System.
ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.
The provided document is a 510(k) summary for the CREO® Stabilization System, Navigation Instruments, and ExcelsiusGPS®. It primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and mechanical testing. The document does not contain the specific information required to complete the detailed table and answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML-based medical devices.
Here's why and what can be extracted:
Why the requested information is not available in the provided text:
The request asks for details typically found in studies for AI/ML-based medical devices, such as:
- Acceptance Criteria/Reported Device Performance (Table): This would typically include metrics like sensitivity, specificity, AUC, or accuracy for a diagnostic/predictive AI. The document discusses mechanical testing criteria for spinal implants and instruments, not performance metrics for an AI system.
- Sample size and data provenance for test set: Relevant for AI algorithm performance evaluation.
- Number of experts and qualifications for ground truth: Essential for establishing ground truth in AI studies.
- Adjudication method: How disagreements among experts are resolved for ground truth.
- MRMC comparative effectiveness study: Measures the improvement in human reader performance with AI assistance.
- Standalone performance: Performance of the algorithm without human intervention.
- Type of ground truth: Pathology, expert consensus, outcomes data.
- Training set sample size and ground truth establishment: Details about the data used to train an AI algorithm.
The devices described (CREO® Stabilization System, various Navigation Instruments, and ExcelsiusGPS®) are spinal implants and surgical navigation systems, which are hardware devices. The text mentions "precisely locating anatomical structures" and "spatial positioning and orientation," which are functions of a navigation system, but it doesn't describe the use of an AI algorithm for diagnostic or predictive purposes that would necessitate the above detailed performance metrics. The navigation systems are designed for use with existing systems like Medtronic StealthStation® and ExcelsiusGPS® robotic arm.
What can be extracted or inferred:
While a table of acceptance criteria for an AI study cannot be created, here's what the document implies about how substantial equivalence was demonstrated:
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical testing in accordance with ASTM F1717 and "Guidance for Spinal System 510(k)s, May 3, 2004" | Demonstrated substantial equivalence to predicate devices (specific numerical results not provided in this summary) |
| Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011 | Results demonstrating compliance (specific results not provided in this summary) |
| Similar technological characteristics, design, intended use, material composition, and function to predicate devices | Deemed substantially equivalent |
Addressing the specific questions based on the provided text:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Mechanical testing (static and dynamic compression, static torsion) per ASTM F1717 and FDA Guidance for Spinal System 510(k)s. Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011.
- Reported Device Performance: The document states that the testing was conducted "to demonstrate substantial equivalence" and that the "information provided within this premarket notification supports substantial equivalence to the predicate devices." Specific numerical performance data is not provided in this 510(k) summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of submission which relies on mechanical testing rather than clinical data or AI algorithm performance data. The "test set" here refers to the physical devices and materials tested.
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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. Ground truth as understood in AI/ML is not established for mechanical testing of physical medical devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: No, an MRMC study was not done as this is not an AI-assisted diagnostic or interpretive device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an AI algorithm. The ExcelsiusGPS® is a navigation system that aids surgeons, but its function as described does not involve an AI algorithm that would have standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the mechanical testing would be the engineering specifications and established standards (ASTM F1717, ANSI/AAMI ST-72:2011).
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The sample size for the training set: Not applicable, as this is not an AI/ML device.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
In summary, the provided FDA 510(k) document is for a traditional medical device (spinal implants and surgical navigation instruments) and not an AI/ML-based device. Therefore, the bulk of the questions asking about AI-specific validation metrics cannot be answered from this text.
§ 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.