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Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures. The Navient system 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 the skull, can be identified relative to a CT, MR-based anatomy model.

Indications:

Example procedures include but are not limited to:

ENT Procedures:

• Transsphenoidal procedures
• Maxillary antrostomies
• Ethmoidectomies
• sphenoidotomies
• Sphenoid explorations
• Turbinate resections
• Frontal sinusotomies
• Intranasal procedures
• Intranasal tumor resections
• All ENT related skull base surgery

Navient is an image guided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via optical tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory set.

Navient's guidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.

The provided FDA 510(k) clearance letter and summary for the Navient Image Guided Navigation System (ENT) do not contain information about the study design or acceptance criteria for AI/algorithm-based performance evaluations. Instead, the document focuses on the system's accuracy, software validation, electrical safety, biocompatibility, and reprocessing validation, all typical for traditional medical devices rather than AI/ML-powered ones.

The document states: "Full system accuracy bench testing: Navient has been validated to the positional accuracy of ≤ 2.0 mm (mean=1.52 mm, STD=0.93 mm, 99% confidence interval of 3.68 mm), with the angular error of ≤ 2.0 deg (mean=1.13 deg, STD=0.43 deg, 99% confidence interval of 2.13 deg). This performance was determined using representative phantoms with system components that are deemed the worst-case in the Navient clinical applications."

This validation refers to the physical navigation system's accuracy in positioning, not the performance of an AI algorithm in tasks like image interpretation or diagnosis. Therefore, I cannot generate the requested table and study details related to AI acceptance criteria and performance based on the specific content provided in this 510(k) document.

The "Navient navigation software" mentioned is described as having a workflow for loading images, planning, setting up, registration, and navigation. This suggests a traditional software interface for guiding the user, rather than an AI/ML algorithm performing diagnostic or predictive functions that would require a ground truth, expert consensus, or MRMC studies.

If we were to hypothetically extract the closest equivalent to "acceptance criteria" for this device, it would be its spatial accuracy, which is a key performance metric for image-guided navigation systems.

Here's a hypothetical structure based on the provided spatial accuracy data, while acknowledging it's not AI-specific:

Hypothetical Acceptance Criteria and System Performance (based on provided spatial accuracy)

Recognizing that the provided document details a traditional image-guided navigation system and not an AI-powered diagnostic/interpretive device, the "acceptance criteria" presented here refer to the system's demonstrated physical accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Test set sample size: Not explicitly stated as a "test set" in the context of an AI model. The performance data is derived from "Full system accuracy bench testing" using "representative phantoms." The number of measurements or phantom tests isn't specified.
• Data provenance: Not directly applicable as it's a bench test on phantoms, not clinical patient data. The testing was conducted internally by ClaroNav.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for positional and angular accuracy in bench testing is defined by precision measurement equipment and physical phantoms, not human experts.

4. Adjudication method for the test set:

• Not applicable. Bench testing does not involve human adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study (MRMC) is typically performed for AI devices that aid human interpretation (e.g., radiologists reading images with AI assistance). The Navient system is a guidance system, not an interpretive AI.

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

• The "Full system accuracy bench testing" represents the standalone performance of the navigation system's hardware and software integration in terms of its ability to track instruments accurately relative to images. It's not an AI algorithm performing a task without human input in the sense of a diagnostic or predictive AI.

7. The type of ground truth used:

• The ground truth for the positional and angular accuracy was established through precise measurements on representative phantoms using calibrated equipment, which is standard for validating the accuracy of surgical navigation systems.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that undergoes a training phase on a dataset of examples. Its software processes sensor data and medical images according to deterministic algorithms.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set in the context of AI/ML for this device's reported validation.

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Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures.

The Navient system 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 the skull, can be identified relative to a CT, MR based model of the anatomy.

Indications:

Example procedures include but are not limited to:

• Cranial Procedures:
• Tumor resections
• · Cranial biopsies
• · Craniotomies
• · Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

Navient is an image quided navigational system intended to assist with preoperative planning and real-time positioning of surgical tools during stereotaxic procedures via (infrared) tracking technology. The system is essentially composed of a computerized main unit (computer), a Navient IR CameraBox, Navient cart, Navient navigation software, and corresponding accessory sets intended for specific clinical applications.

Navient's quidance function is based on the patient images acquired prior to the procedure, combined with optical measurements of the pose of navigated instruments relative to the patient's anatomy. To enable navigation, the reference instrument/accessory is attached to the patient to enable tracking of the patient's anatomy. The patient images are then spatially registered with the patient's anatomy by matching landmark locations marked on both the image and the patient, followed by matching a path traced by the user on the patient's anatomy with a model of patient's anatomical surface automatically generated from the image data.

Depending on the desired clinical application, the Navient system also includes the following instrument/accessory kits. These reusable instruments are intended to be sterilized/disinfected prior to use.

• Cranial Accessory Kit (955-NC-AKC) o
• Biopsy Accessory Kit (955-NC-AKB) O

Disposable tracker instruments are also available based on user preference.

The provided document is a 510(k) summary for the ClaroNav Navient Image Guided Navigation System, Cranial. This document describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The primary acceptance criteria for the Navient system is its accuracy, specifically in terms of positional and angular error. The document states: "Navient has been validated to a mean positional error of ≤ 2.0 mm and a mean anqular error of ≤ 2.0deq."

Here's a table summarizing the acceptance criteria and reported device performance:

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NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).

NaviENT 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 the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.

NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.

Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.

NaviENT consists of four main components:

1. NaviENT Cart
2. Tracking System
3. Laptop Computer
4. NaviENT Instruments

Here's a breakdown of the acceptance criteria and study information for the NaviENT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: For accuracy testing, 3 different human head models were used.
• Data Provenance: The testing was conducted in an OR simulated environment. The country of origin of the data is not explicitly stated, but the submission is from ClaroNav Inc. in Toronto, Canada. Given the context of a 510(k) submission, this would be considered a prospective performance study designed for regulatory approval.

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

This information is not explicitly provided in the document. The accuracy testing was done using "human head models," which typically implies a phantom-based or simulated setup for objective measurement rather than expert-derived ground truth on clinical data.

4. Adjudication Method for the Test Set:

This information is not explicitly provided in the document. For benchtop accuracy testing using physical models, an adjudication method like 2+1 or 3+1 by human experts is typically not necessary. The ground truth would be based on precise physical measurements of the models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

An MRMC comparative effectiveness study is not mentioned in the document. The study described is a device performance and accuracy study, not one designed to evaluate the clinical effectiveness of human readers using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The study described is a standalone performance study of the NaviENT system's accuracy and various other aspects (software, sterility, electrical safety, biocompatibility, human factors). It evaluates the device's inherent performance characteristics rather than how it performs with a human in a clinical setting. The device itself is described as a "computerized surgical navigation system," implying an algorithmic core.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For the accuracy testing, the ground truth was established by physical measurements on human head models within an OR simulated environment. This is a form of engineered or phantom-based ground truth, where the true positions are precisely known or measurable. For other tests (sterilization, biocompatibility, electrical safety), the ground truth is against established ISO and IEC standards and their specific test methodologies.

8. The Sample Size for the Training Set:

This information is not provided in the document. The document describes a medical device with an image guidance component, but it does not detail any machine learning or AI models that would require a separate "training set" in the conventional sense. The "NaviENT software" processes data, but it's not indicated as a learning-based system with a distinct training phase in this submission.

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

As no training set is mentioned (see point 8), this information is not applicable/provided.

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