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510(k) Data Aggregation
(141 days)
Salvo**®** Robotic Navigation Instruments
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, which 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 Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as non-sterile, to be cleaned and steam sterilized by the end user.
The provided FDA 510(k) clearance letter describes the Salvo® Robotic Navigation Instruments and asserts their substantial equivalence to predicate devices. However, the document does not contain the detailed information required to fill out all requested sections about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth details. The letter primarily focuses on the regulatory submission process and the conclusion of substantial equivalence based on dimensional analysis and geometric comparison and compatibility validation testing, rather than a comprehensive performance study that would typically include the requested metrics for AI-powered devices.
Specifically, this device appears to be surgical instruments used with a robotic navigation platform, not an AI or software algorithm itself that would typically have performance metrics like sensitivity, specificity, or AUC. The "dimensional analysis and geometric comparison" and "validation testing to demonstrate compatibility" are more aligned with traditional medical device testing for form, fit, function, and safety, rather than evaluating the diagnostic or predictive performance of an AI system.
Therefore, many sections below will state "Not applicable" or "Not specified in the provided document" because the input document does not detail these aspects as would be expected for an AI/ML-driven device study.
Acceptance Criteria and Device Performance Study Details
Given the nature of the device (robotic navigation instruments, not an AI diagnostic/predictive tool), the acceptance criteria and study detailed in the provided document focus on physical characteristics, compatibility, and safety rather than AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (As implied by the document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Accuracy Performance | Demonstrated accuracy relative to predicate devices through dimensional analysis and geometric comparison. (Implied: instruments operate within acceptable tolerances for navigation) | Evaluated through dimensional analysis and geometric comparison to predicate devices, establishing safety and effectiveness for accuracy. |
| Platform Compatibility | Compatibility with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, including its built-in safety features. | Validation testing demonstrated compatibility of the subject device with the built-in safety feature of the ExcelsiusGPS end effector. |
| Material & Design Equivalence | Equivalent material of manufacture and device design to predicate devices. | Similar device design and dimensions, materials of manufacture, and principles of operation to predicates. |
| Sterilization Process | Non-sterile and reusable; amenable to steam sterilization by the end user (identical to predicates). | Non-sterile, reusable instruments to be steam sterilized by the end user. |
| Intended Use Equivalence | Same intended use as the primary predicate device. | Same intended use as the primary predicate: preparation and placement of screws in spinal procedures with the ExcelsiusGPS platform. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable/Not specified. The document refers to "dimensional analysis and geometric comparison" and "validation testing," which implies testing of instrument prototypes or production units, not a patient or image dataset.
- Data Provenance: Not applicable/Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not specified. The evaluation involved engineering analyses (dimensional, geometric, compatibility) of the instruments themselves, not interpretation of clinical data requiring expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical images or patient data were interpreted, no adjudication method was mentioned or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.
- No. An MRMC study was not done. The device is a surgical instrument, not an AI-assisted diagnostic or interpretative system for human readers. "Clinical testing is not applicable" is explicitly stated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
- Engineering specifications and predicate device characteristics. The "ground truth" for the tests appears to be established engineering tolerances, mechanical specifications, and the established characteristics of the predicate devices for comparison. For compatibility, the ground truth would be the functional requirements of the ExcelsiusGPS® system's safety features.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and dimensions" of the instruments would be engineered and iterated upon, not "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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