(259 days)
Spinal Elements Navigated Instruments are intended to be used during the preparation and placements screws (Overwatch®, Savannah® and Mercury® Fixation Systems) 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Spinal Elements Navigated instruments are non-sterile, reusable instruments designed to function with the the the Medtronic StealthStation® System. Spinal v Elements Navigated instruments are for use with Spinal Elements pedicle screw systems, specifically, Overwatch®, Mercury® and Savannah® pedicle screw systems. Instruments are manufactured from stainless steel.
The provided text describes a medical device, "Spinal Elements Navigated Instruments," which is designed to assist surgeons during spinal surgery. However, the document is a 510(k) summary for a premarket notification to the FDA, asserting substantial equivalence to predicate devices, rather than a detailed study report or clinical trial. Therefore, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in the context of an AI/ML-driven device's performance.
The document primarily focuses on demonstrating substantial equivalence to previously cleared devices through technological characteristics and non-clinical performance testing. It does not describe a study involving AI, machine learning, or human readers.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that the device was tested against a standard practice, but it does not explicitly state specific acceptance criteria (e.g., numerical thresholds for accuracy, precision) or numerical performance results (e.g., "device achieved X% accuracy"). It only provides a qualitative statement about the performance.
| Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance |
|---|---|
| Implicit: Performance sufficient for intended use | "The results of this non-clinical testing show that performance of the Spinal Elements Navigated instruments is sufficient for its intended use and is substantially equivalent to legally marketed devices." |
| Adherence to ASTM F2554 ("Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems") | The device was tested "per ASTM F2554." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described is "non-clinical testing" and refers to "Spinal Elements Navigated instruments" rather than a fixed test set of data or patient cases. The provenance of any underlying "data" (if referring to images or patient data) is not relevant for this type of non-clinical, instrument-centric testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided. The device is a navigated instrument, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from images or patient data. The "ground truth" for instrument accuracy typically comes from metrological standards or precise measurements against known values, not expert consensus on medical images.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (like images) by multiple experts to establish a definitive ground truth. The testing mentioned in the document is non-clinical performance testing of an instrument.
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
A MRMC study was not done. This document describes the clearance of a "navigated instrument" for surgical guidance, not an AI/ML diagnostic or prognostic system. Therefore, there is no mention of human readers, AI assistance, or an effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an instrument designed to be used by a surgeon (human-in-the-loop) with a pre-existing navigation system (Medtronic StealthStation® System). It is not an algorithm that functions standalone.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this navigated instrument, the "ground truth" would likely refer to the true physical position or trajectory relative to a known anatomical landmark, measured using highly accurate metrology equipment during the "non-clinical testing" (ASTM F2554). The document does not specify the exact methodology for establishing this ground truth, beyond referring to the ASTM F2554 standard. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The device is a surgical instrument, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As the device is not an AI/ML model, there is no training set and no ground truth for a training set.
Summary of Device and Study Type:
The "Spinal Elements Navigated Instruments" are physical, reusable surgical instruments designed to integrate with the Medtronic StealthStation® System for precise anatomical localization during spinal surgery. The FDA 510(k) clearance process described here focuses on demonstrating the substantial equivalence of these instruments to previously cleared predicate devices, primarily through non-clinical performance testing related to their mechanical and navigational accuracy. The document explicitly cites compliance with ASTM F2554 for "Measurement of Positional Accuracy of Computer Assisted Surgical Systems" as the basis for performance evaluation. This is not an AI/ML device, and therefore the questions related to AI/ML specific study designs (such as expert consensus, training/test sets for algorithms, MRMC studies) are not applicable.
§ 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).