(129 days)
The Navigated Disc Preparation Instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The Navigated T2 STRATOSPHERE™ templates are intended to facilitate size selection of vertebral body replacement devices during spinal surgery. The Navigated Capstone™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for Elevate™ Spinal System, they are intended to be used to facilitate implant size selection.
The Navigated Probe is intended to be used during pedicle preparation. The Navigated Inserters are intended to be used for the placement of an implant.
Navigated instruments are specifically designed for use with the 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.
Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
The purpose of this submission is to seek clearance for Navigated T2 STRATOSPHERE™ Inserters and Navigated Template, compatible with T2 STRATOSPHERE™ Expandable Corpectomy System for lateral and posterior procedures in thoracolumbar cases only.
The provided text is a 510(k) summary for the Medtronic Navigated T2 STRATOSPHERE Inserters and Navigated Templates. It describes the device, its intended use, and the performance testing conducted to establish substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
The document provides a high-level description of performance testing but does not clearly define specific quantitative acceptance criteria or detailed reported performance values.
| Test | Description | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy | ||
| in both 2D and 3D space. | Likely involves a specific accuracy threshold (e.g., within X mm or degrees) for both 2D and 3D measurements, but not provided. | The document only states "Confirmed navigated instrument accuracy", no specific values. | |
| Anatomical Simulated Use | Confirmed instrument functionality under | ||
| expected use conditions | Likely involves subjective or objective assessment of instrument performance in simulated anatomical models (e.g., smooth operation, correct fit, no breakage) but not provided. | The document only states "Confirmed instrument functionality under expected use conditions", no specific observations. | |
| Navigated Simulated Use | Confirmed navigation system functionality | ||
| under expected use conditions | Likely involves successful tracking, registration, and guidance accuracy during simulated procedures, but not provided. | The document only states "Confirmed navigation system functionality under expected use conditions", no specific observations. | |
| CAD Model Evaluation | Verified that the CAD models are | ||
| accurately reflected in the application | |||
| software. | Likely involves verification of geometric accuracy and representation, but not provided. | The document only states "Verified that the CAD models are accurately reflected in the application software", no specific metrics. | |
| Implant/ Instrument Mating Conditions | Verified that the instruments can be | ||
| assembled with the appropriate devices | |||
| according to their intended use. | Likely involves successful and secure mating of various components, but not provided. | The document only states "Verified that the instruments can be assembled with the appropriate devices according to their intended use", no specific details. | |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has | ||
| met the required interface needs of the | |||
| spine application software | Likely involves successful integration and data exchange between software modules, but not provided. | The document only states "Verified that the Spine Tools package has met the required interface needs of the spine application software", no specific outcomes. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data section broadly describes "performance testing completed" but does not detail the nature of the test sets (e.g., number of instruments tested, number of simulated procedures, specific data sources).
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 provided in the document. The document refers to "testing" but does not mention expert involvement in establishing ground truth for the test. Given the nature of the device (navigated surgical instruments), it's more likely that physical measurements and engineering specifications would serve as ground truth rather than expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is relevant for AI-powered diagnostic devices involving human interpretation of images. This document describes navigated surgical instruments, not a diagnostic AI device. Therefore, an MRMC study as you described would not be applicable to this type of device, and no such study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document in the context of an "algorithm-only" performance for an AI device. The device is a set of physical surgical instruments intended for use with a "StealthStation™ System" (a computer-assisted surgery system), implying a human-in-the-loop scenario. The performance tests ("Navigation Accuracy Analysis," "Anatomical Simulated Use," "Navigated Simulated Use") assess the combined device-system functionality.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given the nature of the tests ("Navigation Accuracy Analysis," "CAD Model Evaluation," "Implant/ Instrument Mating Conditions"), the ground truth would most likely be based on engineering specifications, physical measurements (e.g., using metrology equipment), and functional verification against design requirements. However, the document does not explicitly state the type of ground truth used for each test.
8. The sample size for the training set
This information is not provided in the document. "Training set" is typically a term used for machine learning models. While the StealthStation™ System likely has underlying software and algorithms, the document describes the instruments and their compatibility, not the development of an AI model's training set.
9. How the ground truth for the training set was established
This information is not provided in the document, and likely not applicable in the context of "training set" for the surgical instruments themselves.
In summary, the provided document focuses on demonstrating substantial equivalence of physical surgical instruments and their compatibility with an existing navigation system through engineering and functional testing. It does not provide the detailed study design, specific acceptance criteria, or quantitative performance results typically found in reports for AI-based diagnostic or prognostic devices, which often involve extensive clinical data and human reader studies.
§ 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).