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510(k) Data Aggregation
(59 days)
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spationing 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 Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.
The provided text is a 510(k) summary for the Invictus Robotic Navigation Instruments. It explains that the determination of substantial equivalence (SE) is not based on an assessment of clinical performance data. Instead, it states that the device was evaluated through dimensional analysis and geometric comparison to the predicate devices to establish safety and effectiveness for accuracy performance.
Therefore, the document does not contain the information requested concerning acceptance criteria, device performance, test set sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for training sets.
The relevant section states:
"Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
VII. PERFORMANCE DATA
The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance."
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(65 days)
The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications;
Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ): spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.
Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.
The purpose of this 510(k) submission is to add minimally invasive implants.
Here's an analysis of the provided text regarding the Everest Spinal System, focusing on acceptance criteria and the study proving device performance:
Summary of Acceptance Criteria and Device Performance for the Everest Spinal System
It's important to note that the provided document is a 510(k) summary for a spinal fixation system, and not a diagnostic AI device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards mechanical and design equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI-powered diagnostic tools.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Compression | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 |
| Static Torsion | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 | |
| Dynamic Compression | Performed "equally to or better than" predicate devices in accordance with ASTM F1717 | |
| Design Features | Design of components | "substantially the same as"predicate systems |
| Sizing of Components | Sizing of components | "substantially the same as"predicate systems |
| Material Composition | Materials used | Manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards (Implicitly accepted as equivalent to predicate devices through regulatory compliance) |
| Intended Use | Indications for Use | The system's indications for use are identical to those of the predicate K2M Range Spinal Systems (MESA and DENALI), demonstrating equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
Given this is a mechanical testing and design comparison, the concept of a "test set" and "data provenance" (country of origin, retrospective/prospective) as understood for AI/diagnostic studies is not directly applicable.
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical tests. It would typically involve a certain number of devices or components tested according to ASTM F1717.
- Data Provenance: Not applicable in the context of mechanical testing. The testing would be conducted in a laboratory environment following standardized procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This category is not applicable for the Everest Spinal System 510(k) summary. "Ground truth" in this context refers to an objective standard, which for mechanical performance is established by the ASTM F1717 standard itself and the measured physical properties of the tested devices, not expert human assessment.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts in diagnostic studies. Here, the "truth" is determined by direct mechanical measurements against a standard.
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. This device is a surgical implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies for human reader performance with or without AI assistance are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Everest Spinal System is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Mechanical Measurement Results: Directly measured values from static compression, static torsion, and dynamic compression tests performed according to ASTM F1717.
- Predicate Device Performance: The accepted performance characteristics of the legally marketed predicate devices (K2M Everest Spinal System, K2M Range Spinal System, NuVasive SpherX, Globus Resolve). The new device's performance is compared against these established benchmarks.
- Design and Sizing Equivalence: Direct comparison of the physical design and dimensions of the new components to those of the predicate devices.
- Material Standards: Compliance with ASTM and ISO standards for Titanium Alloy and Cobalt Chrome.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device undergoing mechanical testing and design comparison, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device submission.
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(156 days)
The REVLOK™ Fenestrated Screw System, when used as a posterior pedicle screw system, is 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.
In addition, the REVLOK™ Fenestrated Screw System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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 as an anterolateral thoracolumbar system, the REVLOK™ Fenestrated Screw System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.
The REVLOK™ Fenestrated Screw System consists of monoaxial screws, uniplanar screws, polyaxial screws, dual-outer-diameter screws, reduction screws, rods and locking caps. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVLOK™ implants mate with 5.5mm diameter rods, and 6.35mm implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Locking caps are used to connect the screws to the rod.
The most common use of this screw and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws.
The most common use of this screw and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.
Screws attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine.
The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F67, F1537 and F138. All other REVLOK™ implants are manufactured from titanium alloy or stainless steel, as specified in ASTM F136, F1295, F138 and F67. The REVLOK™ Fenestrated Screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
This is a 510(k) premarket notification for a medical device (Globus Medical, Inc.'s REVLOK™ Fenestrated Screw System), not an AI/ML device. Therefore, the provided information does not contain the specific acceptance criteria and study details outlined in your request.
The document discusses the substantial equivalence of the REVLOK™ Fenestrated Screw System to predicate devices based on mechanical testing, not clinical performance metrics related to AI or human reader improvement.
Here's why the requested information about AI/ML device acceptance criteria and studies cannot be extracted from this document:
- Device Type: The REVLOK™ Fenestrated Screw System is a spinal implant system (screws, rods, locking caps). It is a physical medical device, not a software algorithm or AI/ML diagnostic tool.
- Regulatory Pathway: A 510(k) submission generally demonstrates substantial equivalence to a legally marketed predicate device. This often involves comparing device design, materials, manufacturing processes, and performance (e.g., mechanical strength) to the predicate. It does not typically involve clinical studies with human readers, ground truth consensus, or AI performance metrics.
- Performance Data: The document states, "Mechanical testing (static and dynamic compression and static torsional) was conducted in accordance with ASTM F1717 and the Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. Performance data demonstrate substantial equivalence to the predicate device." This refers to physical engineering tests, not AI-related performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer the questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided 510(k) summary for this mechanical spinal implant system.
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