(146 days)
The Navigated Instrument System is indicated for use during the preparation and placement of Orthofix screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Navigated Instruments are specifically designed for use with the BrainLab Vector Vision system and the Medronic StealthStation System which are 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 for the anatomy.
The Navigated Instrument System is comprised of manual surgical instruments for use with the BrainLab VectorVision System and the Medtronic StealthStation Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Use of the Navigated Instrument System is limited to Taps ranging in sizes of 4.5mm to 8.5mm and bone screws ranging from 4.5mm to 8.5mm with length ranging from 25mm to 55mm.
The Navigated Instrument System Medtronic compatible instruments are comprised of Bone Awl, Bone Taps, and Bone Probes only.
The Navigated Instrument System BrainLab compatible instruments are comprised of Bone Awl. Bone Taps, Bone Probes and a variety of Screw Drivers.
The provided text is a 510(k) summary for a medical device called the "Navigated Instrument System." This document aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove a device meets specific performance acceptance criteria through clinical studies in the typical sense (e.g., diagnostic accuracy on a test set).
Here's an attempt to answer your questions based on the available information, noting that much of it is not explicitly stated in this type of regulatory document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format of a table. Instead, it makes a general statement about substantial equivalence based on "compatibility, accuracy, function and performance."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compatibility with BrainLab VectorVision and Medtronic StealthStation systems. | Demonstrated compatibility with both systems. |
| Accuracy (specific numerical target not provided). | "Accuracy" demonstrated through engineering analysis. |
| Functionality in spinal surgery (preparation and placement of Orthofix screws). | "Function" demonstrated through engineering analysis. |
| Performance during spinal surgery (assisting in locating anatomical structures in open or MIS procedures). | "Performance" demonstrated through engineering analysis. |
| Substantial equivalence to predicate devices (K153442 and K070106). | Concluded to be substantially equivalent based on engineering analysis and non-clinical tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Engineering analysis and performance data" and "non-clinical test." This implies in-vitro or bench testing rather than studies involving patient data. Therefore:
- Sample size for the test set: Not specified, but likely refers to a set of instruments/fixtures used for bench testing, not human subjects or patient data.
- Data provenance: Not explicitly stated, but given it's a 510(k) submission from Orthofix Inc. in Lewisville, Texas, the testing was likely conducted in the US or by an affiliated entity. The data would be non-clinical/bench testing data, not clinical in retrospect or prospect.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided in the context of this 510(k) summary. "Ground truth" in this context would typically refer to clinical data or expert consensus on diagnoses, which is not what was used given the "engineering analysis and performance data" for a surgical instrument system. The ground truth for bench testing would be defined by metrology standards or physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not provided. This usually refers to how disagreements among expert readers are resolved in diagnostic image interpretation studies. Since this device relates to surgical instrumentation and its performance was assessed via engineering analysis, such a method would not be used.
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
No. This is a surgical instrument system, not an AI-powered diagnostic device. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is an instrument system, not an algorithm. Its function is to assist a human surgeon. Standalone performance as an algorithm would not be relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "engineering analysis and performance data" would be based on physical measurements and engineering specifications. For example, the accuracy of instrument tip localization might be verified against known physical coordinates or measurements of a phantom. It is not clinical ground truth like pathology reports or patient outcomes.
8. The sample size for the training set
The concept of a "training set" is primarily relevant for machine learning or AI models. This device is a traditional mechanical/navigated instrument system. Therefore, there is no training set in the AI sense. The "training" for the system would involve calibration procedures and design verification.
9. How the ground truth for the training set was established
As there is no training set in the AI context, this question is not applicable. The design and performance were validated against engineering principles and predicate device characteristics.
§ 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).