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The Disposable Passive Accessory is intended to be used for anatomy palpation in image guided surgeries with Medtronic StealthStation® System. The device is sterile and designed for single use.

Device Description

The IZI Disposable Passive Accessory contains one disposable point probe mounted with five passive reflective sphere markers, as well as ten additional passive reflective sphere markers. The Disposable Passive Accessory is intended to be used for anatomy palpation and registration in image guided surgeries with the Medtronic StealthStation® system. The device is sterile and designed for single use.

The Disposable Passive Accessory provides a single-use alternative to Medtronic reusable parts. The Disposable Passive Accessory is constructed by a dimension stable thermoplastic handle where five passive reflective sphere markers are mounted on, with a stainless steel tip that is used to register and locate patient anatomical structure in an image guided surgery using the Medtronic StealthStation® System. The permanently mounted passive reflective spheres are at the same three dimensional locations as the Medtronic predicate product. In an IGS procedure, the two cameras of the StealthStation® captures the reflective light from the five sphere markers for the System to calculate and determine the location of the stainless tip and the position of the probe.

AI/ML Overview

The provided document, K142344, describes the substantial equivalence of the IZI Disposable Passive Accessory to predicate devices for use in image-guided surgeries with the Medtronic StealthStation System. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device claims to do, or what needs to be met)	Reported Device Performance (How the device performed in testing)
Compatibility with Medtronic StealthStation® System	The "IZI Disposable Accessory with the Medtronic StealthStation S7" study was conducted to ensure compatibility. It verified product performance in the StealthStation® patient registration process and measured navigation accuracy.
Accuracy and Precision (Dimensional Analysis)	A "Design Verification - Dimensional Analysis" study was performed. All critical dimensions affecting passive reflective marker locations and probe tip location were measured against the predicate device. The CpK (Process Capability Index) of all dimensions were reported to be greater than 1.0, indicating the process is capable of producing items within specifications.
Comparable Performance to Predicate Device (Patient Registration & Navigation Accuracy)	The "IZI Disposable Accessory with the Medtronic StealthStation S7" study concluded that the IZI Disposable Passive Accessory performs comparably to the Medtronic Planar Probe with manually mounted Spherz regarding patient registration and navigation error.
Biocompatibility	A cytotoxicity test was performed. The test confirmed that "the product does not cause any cell lysis or toxicity." The materials and components were known to be biocompatible or have a history of use in similar medical devices. The manufacturing process does not use cleaning agents or chemicals.
Sterility	The device is provided as sterile. (No specific test results from this document, but implied by classification and indication).
Single Use	The device is designed for single use. (This is a design characteristic, not a performance metric to be tested against, but an acceptance criterion for its intended use model).
Physical Dimensions and 3D Locations of Marker Post Relative to Probe Tip	In the comparison table, it is stated to be "Same as the Medtronic Passive Planar Probe" and the comparison of technology is "Identical". The dimensional analysis study confirmed that "All critical dimensions that affect the passive reflective marker locations and the probe tip location were measured in the Study against the predicate device. The CpK of all dimensions are greater than 1.0." indicating that this specific criterion was met.
Probe Tip Material	The subject device uses Stainless steel (303 stainless steel), which is comparable to the predicate's Stainless steel (630 stainless steel). Both are stainless steel.
Passive Reflective Marker	The subject device's markers are "Identical to Spherz, permanently mounted onto the probe post". This is deemed identical to the predicate's markers, which are provided separately for manual mounting.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that two non-clinical bench tests were conducted. However, it does not provide specific details on the sample sizes (e.g., number of devices tested, number of measurements taken) for these tests.

Design Verification - Dimensional Analysis: No specific sample size is mentioned, only that "All critical dimensions...were measured in the Study."
Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7: No specific sample size is mentioned for the number of accessories or the number of tests performed on the dummy head. The study used "a pre-scanned Medtronic IGS dummy head."

The data provenance is retrospective, as these are bench tests conducted by the manufacturer for regulatory submission, rather than prospective clinical trials. The country of origin for the data is implicitly the United States, given the submission to the FDA by a US-based company (IZI Medical Products LLC, Maryland).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

No explicit information is provided regarding the use of external experts to establish ground truth for the bench tests. The ground truth for the dimensional analysis would likely be engineering specifications and measurements. For the StealthStation compatibility test, the ground truth for navigation accuracy would be established by the known true positions within the pre-scanned dummy head, and the operational functionality would be against the expected behavior of the Medtronic StealthStation System. These are internal engineering and performance benchmarks rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the studies are non-clinical bench tests. The performance metrics (CpK, navigation error) are quantifiable and objective, not requiring human interpretation or adjudication in the medical sense.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a passive accessory (a probe) for an image-guided surgery system, not an AI-based diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a hardware accessory (a probe), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's function is inherently human-in-the-loop as it is used by a surgeon for palpation and registration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these non-clinical bench tests was based on:

Engineering Specifications and Measurements: For the "Design Verification - Dimensional Analysis," the ground truth was the engineering specifications of the predicate device and the physical measurements taken.
Known Physical Coordinates/System Functionality: For the "Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7," the ground truth for navigation accuracy was derived from the known positions within the pre-scanned Medtronic IGS dummy head and the expected operational parameters of the StealthStation® System itself.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/machine learning model, this question is not applicable.

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