(30 days)
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.
Navigated surgical 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.
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 provided text describes a 510(k) premarket notification for the Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments. It's a submission for a medical device to the FDA, asserting substantial equivalence to a previously cleared predicate device.
The document focuses on demonstrating that the new device has identical intended use, fundamental scientific technology, sterilization method, materials, and compatibilities with the StealthStation™ System as the predicate devices.
Crucially, this document highlights performance testing in a general sense, but it does NOT provide the specific acceptance criteria or the detailed results (e.g., numerical performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would typically be found in a detailed study report for AI/ML device performance.
Therefore, I cannot fulfill most of your request directly from the provided text, as it doesn't contain the detailed data for an AI/ML study. The device itself is "Navigated Instruments," not an AI/ML algorithm that would typically undergo the kind of performance validation you've outlined.
However, I can extract what is present regarding "performance data" which refers to engineering/bench testing rather than clinical AI/ML performance.
Here's an attempt to answer based on the engineering/functionality testing mentioned, noting where the information for an AI/ML study is not present:
Based on the provided FDA 510(k) summary, the device is the Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments. This is a set of navigated surgical instruments intended for use with the StealthStation™ System. The summary focuses on demonstrating substantial equivalence to a predicate device through functional and engineering testing, rather than an AI/ML performance study as typically seen with diagnostic algorithms.
Therefore, the information regarding "acceptance criteria" and "device performance" in the context of an AI/ML model's diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not present in this document. Instead, the document discusses functional performance testing to ensure the instruments work as intended with the navigation system.
Here's a breakdown based on the information provided, and where information for an AI/ML study is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes "Performance Data" which refers to the validation of the instruments' functionality and compatibility, rather than AI/ML model performance metrics. Specific numerical acceptance criteria and reported numerical performance values are not provided for these tests.
| Test Title | Description | Acceptance Criteria (Not Detailed) | Reported Device Performance (Not Detailed) |
|---|---|---|---|
| Navigation Accuracy Analysis | Confirmed navigated instrument accuracy in both 2D and 3D space | Confirmed accuracy (Specific numerical criteria not provided) | Passed (Specific numerical results not provided) |
| Anatomical Simulated Use | Confirmed instrument functionality under expected use conditions | Confirmed functionality (Specific criteria not provided) | Passed (Details of how functionality was confirmed not provided) |
| Navigated Simulated Use | Confirmed navigation system functionality under expected use conditions | Confirmed functionality (Specific criteria not provided) | Passed (Details of how functionality was confirmed not provided) |
| CAD Model Evaluation | Verified that the CAD models are accurately reflected in the application software | Verified accurate reflection (Specific metrics/tolerances not provided) | Passed (Details of verification not provided) |
| Implant/Instrument Mating Conditions | Verified that the instruments can be assembled with the appropriate devices according to their intended use | Verified proper assembly (Specific criteria not provided) | Passed (Details of verification not provided) |
| Spine Tools Package Functional Testing | Verified that the Spine Tools package has met the required interface needs of the spine application software | Verified required interface needs met (Specific criteria not provided) | Passed (Details of verification not provided) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable / not provided as the validation described is for physical instruments and software compatibility, not an AI/ML model evaluated on a test set of patient data (e.g., images).
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable / not provided for the type of engineering/functional testing described. Ground truth as typically understood for an AI/ML clinical study (e.g., expert radiological review) is not part of this submission's performance data section.
4. Adjudication Method for the Test Set
This information is not applicable / not provided as there is no mention of a human-reviewed test set requiring adjudication in the context of typical AI/ML performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable / not provided. The document describes functional testing of surgical instruments and their compatibility with a navigation system, not a comparative effectiveness study involving human readers assisted by AI.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable / not provided. The device is an instrument, not a standalone AI algorithm. While it integrates with a "StealthStation™ System" (a navigation system), the performance evaluation described focuses on the instruments' functionality and compatibility, not a standalone AI algorithm performance.
7. Type of Ground Truth Used
For the described functional tests, "ground truth" would be established by engineering specifications, successful physical mating, accurate measurements, and correct software rendering. This is distinct from clinical ground truth (e.g., pathology, follow-up outcomes, expert consensus on patient data) relevant for AI/ML diagnostic or prognostic algorithms.
8. Sample Size for the Training Set
This information is not applicable / not provided. There is no mention of a "training set" as this is not an AI/ML model for which training data would be used to develop.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided as there is no training set for an AI/ML model involved.
In summary: The provided FDA 510(k) document pertains to navigated surgical instruments and their functional validation, not to an AI/ML algorithm requiring a clinical performance study with detailed metrics on diagnostic accuracy, reader performance, or clinical ground truth. The "Performance Data" section lists engineering and functional tests to confirm the device's operation and compatibility, but it does not specify numerical acceptance criteria or detailed results.
§ 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).