(101 days)
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 MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Navigation Instruments are nonsterile, reusable instruments including awls, probes, drill bits, drill guides, taps, and drivers that can be operated manually or with a power drill such as POWEREASE™. These instruments are intended to be used with the Medtronic Synergy Spine and Trauma StealthStation® System (v 2.1.0).
The provided text describes a 510(k) premarket notification for "Navigation Instruments" by Globus Medical Inc., intended for use with the Medtronic StealthStation® System in spinal surgery. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, quantitative acceptance criteria for algorithm or AI performance.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/algorithm performance (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance), training data, etc., is not present in this type of regulatory submission. This document describes a medical device, not an AI/ML algorithm.
However, I can extract the relevant information that is present:
Acceptance Criteria and Device Performance (as inferred from the submission):
| Acceptance Criteria Category | Specific Criteria (Inferred from submission) | Reported Device Performance |
|---|---|---|
| Functionality & Compatibility | Instruments can be registered to the Medtronic StealthStation® System using the NavLock tracker. | "Registration testing was performed to ensure that the instruments can be registered to the StealthStation®." (Implies successful registration) |
| Accuracy | Accuracy comparable to predicate instruments. | "Accuracy testing was completed for comparison to the predicate instruments." (Implies comparable accuracy, as it supports substantial equivalence) |
| Intended Use | Acceptable for use during preparation and placement of specified Globus screws in spinal surgery to assist in precisely locating anatomical structures. | "Design validation testing... was conducted to ensure the Navigation Instruments are acceptable for their intended use..." (Implies successful validation for indicated use) |
| Substantial Equivalence | Technical characteristics, performance, and intended use are similar to predicate devices. | "Navigation Instruments have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use." "The information provided within this premarket notification supports substantial equivalence..." |
| Biocompatibility | Patient-contacting materials meet applicable standards or are used in 510(k) cleared devices. | "Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices." |
Information Not Present in the Document:
The following requested information is not available in the provided 510(k) summary, as it pertains to AI/ML algorithm validation, which is not the subject of this device submission:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of Study (as described in the document):
The study described is a design validation testing for the "Navigation Instruments" to demonstrate their functionality, accuracy, and compatibility with the Medtronic StealthStation® System, and ultimately, their substantial equivalence to existing predicate devices.
- Type of Study: Design validation and comparative testing for substantial equivalence.
- Focus: Mechanical and functional performance (registration, accuracy) of surgical instruments designed for use with a navigation system, rather than an AI algorithm's diagnostic or predictive performance.
- Ground Truth: Implicitly, the ground truth for accuracy and functionality testing would be established through engineering measurements and comparisons to known performance of predicate devices or established technical specifications. No expert consensus or outcomes data for diagnostic purposes is mentioned.
- Sample Size: Not specified for any testing.
- Data Provenance: Not specified.
- Experts/Adjudication: Not relevant for this type of mechanical device testing.
- MRMC/Standalone AI Performance: Not applicable as the device is not an AI/ML algorithm.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).