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510(k) Data Aggregation
(96 days)
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
The iFuse-Navigation instrument set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
The provided text describes a 510(k) premarket notification for the iFuse Implant System - iFuse Navigation. Let's extract the requested information regarding acceptance criteria and the study proving the device meets them.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a dedicated table format with reported device performance values. It describes the types of tests performed and implies that the device passed these tests to achieve substantial equivalence.
Based on the "Performance Data" section (Page 4), the following can be inferred:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Registration | Instruments can be registered to the StealthStation.® (Implies successful registration) |
| Accuracy | Performed for comparison to reference instruments. (Implies satisfactory accuracy compared to reference) |
| Rigidity | Connection between the TeraTracker and the instruments was evaluated. (Implies sufficient rigidity) |
| Compatibility with iFuse Implant System | Evaluated to ensure compatibility. (Implies successful compatibility) |
Note: The document only states that testing was "completed to ensure the functionality and compatibility" and that "verification and validation results support substantial equivalence." No specific numerical thresholds or measured performance values are provided.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size (e.g., number of tests, number of devices tested, number of simulated procedures) used for any of the performance tests.
It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not refer to the use of experts to establish ground truth for the performance tests. The tests described (Registration, Accuracy, Rigidity, Compatibility) appear to be engineering verification and validation tests rather than clinical studies requiring expert interpretation of results against a medical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned, as the tests do not appear to involve human interpretation necessitating such a method.
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 MRMC comparative effectiveness study was done or mentioned. This device is a surgical navigation instrument, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an instrument used with a navigation system and by a surgeon, not a standalone algorithm. The performance tests appear to be evaluations of the instrument's interaction with the navigation system and its physical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically understood in medical device validation (e.g., against pathology for a diagnostic device) does not seem applicable here in the traditional sense. The "ground truth" for the performance tests would be the established engineering specifications, system requirements, and the expected functional behavior of the instruments in conjunction with the StealthStation® system and iFuse Implant System. The tests aim to verify that the device meets these pre-defined specifications.
8. The sample size for the training set
The document does not mention a training set. This is consistent with the nature of the device as a physical surgical instrument and not an AI/machine learning system that requires a training phase.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed or implied.
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