(106 days)
The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.
The provided FDA clearance letter concerns the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments). This letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and engineering analysis rather than a human reader study or AI performance evaluation.
Therefore, many of the requested details, such as those pertaining to AI model training, human reader studies (MRMC), or a comprehensive standalone algorithm performance, are not explicitly available within this document. The device in question is a set of surgical instruments, not an AI or imaging device requiring such detailed performance evaluation in the context of this 510(k) submission.
However, based on the provided text, we can extract information regarding the performance data used to demonstrate safety and effectiveness for these specific instruments.
Acceptance Criteria and Reported Device Performance
The letter states that the instruments were evaluated for their accuracy performance and their ability to register with the navigation system and fit within the guide tube of the end-effector.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Accuracy Performance | Precise location of anatomical structures when used with the Globus ExcelsiusGPS System. | Demonstrated through "engineering analysis and geometric comparison to predicate devices." No specific numerical accuracy metrics (e.g., in mm) are provided in this document. |
| System Registration | Adequately register with the navigation system (Globus ExcelsiusGPS System). | "Pass/fail verification testing demonstrated that the subject instruments adequately registered with the navigation system." |
| Instrument Fit | Appropriately fit within the guide tube of the end-effector. | "Pass/fail verification testing demonstrated that the subject instruments...appropriately fit within the guide tube of the end-effector." |
| Usability/Functionality | Functionality as taps and drivers for pedicle screw placement, providing navigation array attachment. | "The subject instruments have equivalent critical dimensions and functionality with the ExcelsiusGPS System hardware and software." |
| Biocompatibility | Ensuring the materials are safe for patient contact. | "Biocompatibility evaluation of the instruments was leveraged from cited additional predicate devices by Innovasis, Inc." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of a clinical study. The evaluation appears to be primarily an engineering analysis and verification testing on the instruments themselves.
- Data Provenance: The study described is a technical evaluation of the instruments, not a clinical trial with patient data. It is an "engineering analysis and geometric comparison to predicate devices," and "pass/fail verification testing." The location of this engineering and testing work is not specified, but the applicant (Innovasis, Inc.) is based in Salt Lake City, Utah, and their regulatory consultant in Colorado Springs, Colorado, suggesting a U.S.-based context for the submission. The information implies a retrospective approach in terms of comparing to existing designs and prospective in terms of conducting new verification tests on the manufactured instruments.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission does not describe a study involving expert readers or medical professionals establishing ground truth for diagnostic interpretation. The "ground truth" for this device relates to its physical and functional specifications (e.g., dimensions, fit, compatibility with the navigation system), established through engineering methods.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used in studies where human experts are interpreting medical images or data and discrepancies need to be resolved. This study is an engineering and verification test.
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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. This device is a surgical instrument set and the submission does not mention an MRMC study or any AI component that would assist human readers in image interpretation or diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is not an algorithm. The "performance data" refers to the instrument's mechanical and functional compatibility.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Functional Compatibility. The ground truth for this device's performance is based on established engineering principles, design specifications, and the functional requirements for compatibility with the predicate navigation system (Globus ExcelsiusGPS). This includes geometric tolerances, material properties, and successful registration/fit with the navigation platform.
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not Applicable. As above, this is not an AI/machine learning device. The "ground truth" for the device's design and function would be based on engineering design principles and specifications, tested through verification.
§ 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).