(238 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 Instrument System reusable instruments are specifically designed for use with the Brainlab Vector Vision system and the Medtronic 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.
Use of the Navigated Instrument System is limited to use only with the Firebird Spinal Fixation System / Phoenix MIS Spinal Fixation Systems.
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 and Brainlab compatible instruments are comprised of Bone Awl, Bone Taps, Bone Probes and a variety of Screw Drivers.
The provided text, a 510(k) summary for the Orthofix Navigated Instrument System, describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance data. However, it does not contain a detailed study report that includes specific acceptance criteria and reported device performance in a table format, nor does it provide details on sample sizes, provenance, expert qualifications, or adjudication methods.
Here's an analysis of what information is available and what is missing, based on your request:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states "Engineering analysis and performance data demonstrate that the subject Navigated Instruments are substantially equivalent to the predicate devices in compatibility, accuracy, function and performance." It also mentions "accuracy and performance testing...in a simulated surgical navigation use environment." However, it does not provide a table outlining specific acceptance criteria (e.g., "Accuracy within X mm") or the numerical results achieved by the device against those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document mentions "physical testing with all Navigated Instrument System Screwdrivers" but does not specify the sample size for this test set or the provenance of any data used (e.g., if it was from a specific country, or if it was retrospective or prospective).
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)
- Not applicable / Missing. Given that this is a non-clinical evaluation for navigation instruments, the "ground truth" would likely relate to objective measurements of accuracy and compatibility rather than expert interpretation of medical images or outcomes. There is no mention of experts establishing a ground truth for a test set in the traditional sense of clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Missing. Adjudication methods are typically used in studies involving human interpretation or subjective assessments where discrepancies need to be resolved. This document describes an engineering analysis and physical testing, so an adjudication method is not relevant.
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
- Not applicable. This device is a "Navigated Instrument System" used with existing navigation systems (BrainLab VectorVision and Medtronic StealthStation). It is a physical instrument for surgical guidance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in image interpretation. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a system of physical instruments, not an algorithm. The performance evaluation is related to the physical instruments' compatibility, accuracy, and function within established navigation systems, which inherently involve a "human-in-the-loop" (the surgeon).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Inferred, but not explicitly stated. For an "accuracy and performance testing...in a simulated surgical navigation use environment," the ground truth would likely be established through precise measurements of the instrument's tip position relative to a known target or planned trajectory, validated by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines). The inherent "ground truth" for compatibility would be successful functional integration with the navigation systems and the specific screws. However, the document does not explicitly describe the "type of ground truth" in detail.
8. The sample size for the training set
- Not applicable. This device is a physical instrument system. It does not involve machine learning or AI models that require a "training set" of data.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, this information is not relevant.
Summary of what is available from the text:
- Device Name: Navigated Instrument System
- Purpose of Evaluation: To demonstrate substantial equivalence to predicate devices (K153442, K070106, K162921) regarding "compatibility, accuracy, function and performance."
- Testing Information:
- "Engineering analysis and performance data"
- "Dimensional measurements of both the predicate devices and subject devices and geometrical comparisons to currently marketed Orthofix Instruments."
- "Validation testing includes physical testing with all Navigated Instrument System Screwdrivers..."
- "...to ensure compatibility with the system software and 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."
- Systems used for compatibility testing: Medtronic StealthStation S7 Orange, Violet, and Gray Navlock Tracker, Medtronic Navigation Instrument Driver, Navlock Reference Frame, and Navigated CD Horizon Solera Operative Technique; Brainlab VectorVision System.
In conclusion, while the document asserts that testing was performed to demonstrate substantial equivalence in compatibility, accuracy, function, and performance, it lacks the specific quantitative details, study methodologies, and explicit acceptance criteria that your request requires. The information provided is at a high-level summary suitable for a 510(k) submission, not a detailed study report.
§ 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).