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The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the acurate placement of pedicle screws. The device is sterile and designed for single use.

Device Description

The IZI Pedicle Access Kit consists of one pedicle access needle with cannula. The handle contains 4 retro-reflective Navigation Markers (Spherz K022074). The device is sterile and designed for single use. The patient-contacting components are the stainless-steel cannulas and needle. The product is used to gain access to the pedicle in image guided surgeries using the 7D Surgical System. The retro-reflective Navigation Markers (Spherz) that are attached to the handle allows the camera system of 7D Surgical System (K180352) to accurately locate where the tip of the needle is in space.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IZI Navigated Pedicle Access Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format like typical sensitivity/specificity thresholds. Instead, it describes performance based on accuracy testing and conformance to standards. The reported device performance is demonstrated by its compliance with these tests and standards, showing that it performs as safely and effectively as the predicate device.

Test/Standard	Acceptance Criteria (Implied)	Reported Device Performance
Non-Clinical Performance Surgical Simulations on Phantom Models	The device accurately navigates and assists in pedicle screw placement in a simulated surgical environment with the 7D Surgical System, demonstrating equivalent performance to the predicate.	Performed to verify absolute accuracy, repeatability of accuracy, and navigation accuracy with the 7D Surgical System.
ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems	Compliance with the standard for measuring positional accuracy of computer-assisted surgical systems.	Accuracy testing performed according to this standard to verify absolute accuracy and repeatability of the device and navigation accuracy.
Target Registration Error (TRE) Evaluation	TRE should demonstrate acceptable clinical accuracy of the system on phantom models in a clinical simulated environment.	Used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment.
Biocompatibility Profile	Same biocompatibility profile as the reference device K1423244.	The IZI Pedicle Access Kit has the same biocompatibility profile as the reference device K1423244.

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

Test Set Sample Size: The document does not specify a numerical sample size for the "phantom models" used in the non-clinical performance surgical simulations. It mentions "phantom models" generally.
Data Provenance: The data is based on "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models." This indicates it's retrospective simulation data from a controlled lab environment, not from human patients. The country of origin for the data is not specified, but the applicant (IZI Medical Products LLC) is based in Maryland, USA, and the predicate device manufacturer (7D Surgical Inc.) is in Ontario, Canada, suggesting a North American context for the testing.

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

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the non-clinical simulations. The "ground truth" for TRE is described as "measured physically or otherwise," implying objective physical measurements rather than expert consensus on images.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the evaluation appears to be based on objective physical measurements (e.g., TRE) in a simulated environment, not subjective assessment by multiple individuals.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. This document describes a device (a physical surgical instrument) and its navigation accuracy when used with a surgical system, not an AI diagnostic algorithm that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance:

Yes, a standalone performance assessment (algorithm only, without human-in-the-loop performance) was effectively done. The performance metrics (absolute accuracy, repeatability, navigation accuracy, and TRE) are for the device (IZI Navigated Pedicle Access Kit) and its interaction with the 7D Surgical System in a simulated environment. There isn't a "human-in-the-loop" component being evaluated in these specific non-clinical tests.

7. Type of Ground Truth Used:

The ground truth used was objective physical measurements in a phantom model. For TRE, it's defined as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a gold standard established by precise physical measurement to compare against the system's reported position.

8. Sample Size for the Training Set:

The document does not mention a "training set" or "training data." This submission is for a physical surgical device, not a machine learning or AI algorithm in the context of data training. The "device performance tests" are verification and validation activities, which are akin to testing, not training.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.

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