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iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures 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.

iFuse Implant System - 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.

This document is a 510(k) summary for the iFuse Implant System - iFuse-Navigation Instrument Set. It describes a medical device, specifically a surgical instrument used with a navigation system for sacroiliac joint surgery, and asserts its substantial equivalence to a predicate device.

The provided text does not contain the detailed information required to answer your specific questions regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K172268) based on having the same intended use/indications for use, similar technological characteristics, and no changes in operating principle, component materials, manufacturing processes, or sterilization method.

The Section "VIII. SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES" states: "Performance testing conducted on the proposed device demonstrates that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The following testing were successfully performed for the 4.0 mm Navigation Broach: registration with Medtronic StealthStation and dimensional analysis."

This is a very high-level summary and does not provide the specific acceptance criteria or the reported performance data in a quantitative manner that would allow for the creation of the requested table. It also does not describe the study methodology in enough detail to answer questions about sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for detailed information about acceptance criteria and the study that proves the device meets them based solely on the provided text. The document indicates that testing was performed, but it does not present the results or the details of those tests.

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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:

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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