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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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The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

The TruDi® Navigation System V3 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. The TruDi® Navigation System V3 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same technology used by the predicate device. The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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

The document does not specify a distinct "test set" in the context of human data or patient cases. The performance data is derived from non-clinical bench testing and simulated use.

• Bench Location Accuracy: This test compared the TruDi® Navigation System's electromagnetic locations to those provided by a highly accurate robot system over its entire navigation volume. While a sample size of "locations" would have been involved in this measurement, the specific number is not provided.
• Simulated Use Location Accuracy: This involved performing a complete CT image registration and instrument navigation workflow. The specific sample size for "simulated uses" is not provided.

The data provenance is not from human patients; it's from laboratory (bench) and simulated environments. Therefore, country of origin is not applicable in the typical sense.

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

This information is not applicable as the 'test set' for accuracy was based on objective measurements (robot system, simulated workflow) and not on expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth was established through objective measurement tools and processes (robot system, simulated workflow) rather than human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to determine that the subject TruDi® Navigation System V3 performs as intended." This indicates that the evaluation was purely technical and non-clinical.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation of the device's core accuracy functions was done. The "Location Accuracy tests... where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system" directly assesses the system's inherent accuracy in a controlled, non-human environment. The "Simulated use accuracy test" also falls under this, evaluating the system's accuracy within a simulated workflow.

7. The Type of Ground Truth Used

The ground truth used for accuracy assessments was based on:

• Highly accurate robot system measurements for Location Accuracy tests.
• Known/defined parameters within a simulated use workflow for Simulated Use Location Accuracy tests.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This device is a navigation system primarily relying on electromagnetic tracking technology, not a machine learning model that typically requires a separate training set.

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

This information is not applicable as there is no mention of a training set or its ground truth establishment within the provided document.

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ENT EM is intended as an image-guided planning and navigation system to enable ENT procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as:

• Intranasal structures and Paranasal Sinus Surgery
  • Functional endoscopic sinus surgery (FESS)
  • Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy
• Anterior skull base procedures

The Subject Device ENT EM is an image guided planning and navigation system to enable navigated surgery during ENT procedures. It offers guidance for setting up the EM equipment, different patient image registration methods and instrument selection and calibration to allow surgical navigation by using electromagnetic tracking (EM) technology. The device provides different workflows guiding the user through preoperative and intraoperative steps. To fulfill this purpose, it links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in ENT procedures. The software is installed on a mobile Image Guided Surgery (IGS) platform (Kick 2 Navigation Station or Curve Navigation 17700) to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart and an EM tracking unit for image guided surgery purposes. ENT EM consists of: Several software modules for registration, instrument handling, navigation and infrastructure tasks, IGS platforms and surgical instruments for navigation, patient referencing and registration.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Brainlab ENT EM system, which incorporates an AI/ML-based function for pre-registration in surface matching.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set used for the AI/ML algorithm's performance evaluation. It mentions that "The model's prediction and performance are then evaluated against the test pool. The test pool data is set aside at the beginning of the project."

The data provenance is not explicitly stated regarding country of origin or specific patient demographics. However, it indicates a "controlled internal process" for development and evaluation. It's a static algorithm (locked), suggesting it's developed and tested once rather than continuously learning. The context implies it's retrospective as data was "set aside."

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

This information is not provided in the text. The document refers to "landmarks delivered by a ML based calculation" and compares its performance to a "conventional" method in the reference device, but it doesn't detail how the ground truth for these landmarks was established for testing.

4. Adjudication Method for the Test Set

The adjudication method for establishing ground truth for the test set is not explicitly described.

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

There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed with human readers to assess improvement with AI vs. without AI assistance. The testing primarily focuses on the AI/ML algorithm's performance equivalence to the predicate/reference device's conventional method, and overall system accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a form of standalone performance evaluation was done for the AI/ML algorithm. The text states: "Performance testing comparing conventional to machine learning based landmark detection were performed showing equivalent performance as in the reference device." This implies an evaluation of the algorithm's output (landmark detection) without a human reader in the interpretation loop, by comparing its results directly to a "conventional" method.

7. The Type of Ground Truth Used for Performance Testing

The type of ground truth for the AI/ML landmark detection is implicitly based on the "conventional" landmark detection method used in the reference device. The document states "Performance testing comparing conventional to machine learning based landmark detection were performed showing equivalent performance as in the reference device." This suggests the conventional method's output serves as the reference ground truth, or there's an established "true" landmark position that both are compared against. For system accuracy, the ground truth is established through physical measurements of "Mean Positional Error" and "Mean Angular Error" against a known configuration.

8. The Sample Size for the Training Set

The document does not provide the numerical sample size for the training set. It mentions the algorithm was developed using a "Supervised Learning approach" and that "the training process begins with the model observing, learning, and optimizing its parameters based on the training pool data."

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

The method for establishing ground truth for the training set is not explicitly detailed. It only states that the algorithm was developed using a "Supervised Learning approach" and a "controlled internal process" that defines activities from "inspection of input data to the training and verification." This implies that the training data included true labels or targets for the landmarks that the AI/ML algorithm was trained to detect, but the source or method of obtaining these true labels (e.g., expert annotation, manual registration results) is not specified.

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TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

• · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
• · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
• · Orbital decompression
• · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
• · Access to the sphenoid sinus

The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Stryker ENT Navigation 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 in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

• Transphenoidal access procedures;

• Intranasal procedures;

• Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies;

• ENT related anterior skull based procedures.

The Stryker ENT Navigation System is a computer-assisted image-guided surgery system. The system displays the position of navigated instruments on a model of the patient's anatomy based on preoperative images (CT or MRI) using electromagnetic tracking technology. The position of the instruments and the patient are localized within an electromagnetic field produced by a field generator. The navigation of instruments relative to the patient's anatomy is established via registration of the patient's anatomy to the preoperative images via anatomical landmarks, or surface matching. The position of navigated instruments is then displayed with respect to preoperative images.

The system comprises a computer platform, the software, patient trackers, pointers and suction tubes, instrument trackers, and a dedicated calibration body.

This submission is about the new version 3.6 of the Scopis software application, and the updated computer platform called Electromagnetic Navigation Unit with the new operating system version 3.6.A.

The provided text describes the Stryker ENT Navigation System and its associated software, but it does not include a study that proves the device meets specific acceptance criteria in the way described in the prompt's request.

Instead, the document states:

• "To ensure accuracy, subject devices are tested in accordance with ASTM F2554. The devices meet state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy."
• "Scopis software applications were subject to verification and validation testing in compliance with IEC 62304 and FDA guidances. All testing criteria were met."

This indicates that internal testing was conducted against existing standards and internal acceptance criteria, but the specific results of such a study are not detailed in the provided K221098 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed clinical or performance study with specific metrics as requested.

Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's what can be inferred or explicitly stated from the document, along with what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated for accuracy testing. The document mentions "subject devices are tested," implying device-level testing rather than patient data.
• The "Performance Data" section discusses non-clinical testing. Clinical testing was "deemed unnecessary."

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

• Not applicable/Not stated. No clinical study involving expert ground truth establishment is described or referenced. The testing mentioned is non-clinical.

4. Adjudication method for the test set:

• Not applicable/Not stated. No clinical study or expert review process is described.

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. The document explicitly states, "No clinical testing was deemed necessary for this Traditional 510(k) submission." This is not an AI-assisted diagnostic device for image interpretation by human readers. It's an image-guided surgery navigation system.

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

• Yes, in spirit, for the non-clinical performance aspects. The accuracy, software, electrical safety, safety, and security tests can be considered "standalone" evaluations of the device's functional and safety characteristics without human-in-the-loop performance in a clinical context. However, this isn't a traditional "algorithm only" performance evaluation as one might see for an AI diagnostic device. It's about the technical performance of the navigation system components.

7. The type of ground truth used:

• For the Accuracy testing (ASTM F2554), the ground truth would typically be established by highly accurate measurement systems and physical phantoms.
• For Software testing (IEC 62304), the "ground truth" would be the specified software requirements and expected behavior, validated through testing protocols.
• For Electrical Safety, EMC, Safety, and Security, the "ground truth" is adherence to the technical standards and regulations.

8. The sample size for the training set:

• Not applicable/Not stated. This device is a navigation system, not a machine learning model that requires a "training set" in the traditional sense for medical image analysis. Its "training" is in its engineering design and software development, not in learning from a large dataset.

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

• Not applicable/Not stated. As explained above, this isn't a machine learning model that involves a training set with established ground truth from data.

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The Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube Navigation 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 in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures

The Cube Navigation System is an image guided surgery system, visualizing instrument positions on preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field, generated by a field generator, called navigation sensor within the Cube navigation system. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by surface matching performed by the user either tactile using an navigated instrument or non-tactile using the registration device VituEye. Thereafter the spation of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

The provided text is a 510(k) Summary for the Fiagon Cube Navigation System. It details the device's technical specifications, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a full clinical study with acceptance criteria and detailed performance of an AI-driven vision system.

Therefore, the document does not contain the specific information requested regarding acceptance criteria related to AI performance, sample sizes for test sets (beyond general bench testing), data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone algorithm performance, or ground truth establishment for training and test sets in an AI context.

The document primarily focuses on the device's accuracy as a navigation system, but this is a mechanical/electrical performance metric, not an AI diagnostic performance metric.

However, I can extract the relevant acceptance criterion and the reported performance for the device's accuracy:

Acceptance Criteria and Reported Device Performance (as related to accuracy):

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The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments.

The Stryker ENT Navigation 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 in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

• Transphenoidal access procedures:

• Intranasal procedures;

• Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;

• ENT related anterior skull based procedures.

The Instrument Clamps Electromagnetic are part of the Stryker ENT Navigation System. The basic principle of this system is the generation of an electromagnetic (EM) field with an EMemitter (Field Generator). The EM devices have sensor coils that transform the detected EM field into an analogue signal is transmitted via cable to the Electromagnetic Navigation Unit. The signal is then evaluated, and the tracking data is transmitted to the platform. This technology allows tracking instruments without a line-of-sight requirement.

The Instrument Clamps Electromagnetic are to be used for localizing surgical instruments in a dedicated working volume. They are intended to be mounted on suitable surgical rigid instruments. The body of the clamp incorporates the required sensor coils, which enables tracking of conventional instruments. For accurate navigation, the instrument with the attached electromagnetic clamp needs to be calibrated prior to use.

Two electromagnetic clamps are in scope of this submission:

• Instrument Clamp Electromagnetic Sphere: Clamping interface optimized for tracking instruments with a circular cross-section between 2.0 mm and 4.6 mm in diameter (inclusive)
• . Instrument Clamp Electromagnetic Universal: Clamping interface optimized for tracking instruments with angular cross-section (e.g. forceps) between 3.0 mm and 6.0 mm in diameter (inclusive)

The subject devices are not intended to have patient contact. Their bodies are made of PEEK and the clamps and screws are manufactured from titanium.

They are reusable devices that need to be reprocessed prior to first use. They are limited to 10 uses.

The provided text describes the 510(k) premarket notification for the "Instrument Clamps Electromagnetic" by Stryker Corporation. The document focuses on establishing substantial equivalence to a predicate device (Scopis Extended Instrument Set EM, K171661) rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial. However, it does outline performance testing related to accuracy, reprocessing, and electrical safety.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the performance testing for accuracy was conducted according to ASTM F2554. It indicates that "The devices meet state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy." However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., actual point accuracy values, precision values, or distance accuracy values) are not provided in the text.

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

The document does not specify a "test set" in the context of a clinical study with patients or data. The testing described is bench testing. Therefore, information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable to the type of testing presented.

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

Ground truth establishment by experts is typically relevant for clinical studies or image-based AI studies. Since the testing described is bench testing of physical device characteristics (accuracy, reprocessing, electrical safety), this information is not applicable.

4. Adjudication Method for the Test Set:

As no expert- Adjudicated test set is described, the adjudication method is not applicable.

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

No clinical studies, and specifically no MRMC comparative effectiveness studies involving human readers, were performed or are described in the provided text. The document explicitly states: "No clinical testing was deemed necessary for this 510(k) submission." Therefore, information on effect size of human readers with/without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

The device is a physical instrument clamp for surgical navigation, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable. The accuracy testing refers to the physical tracking performance of the instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the bench testing described:

• Accuracy: The ground truth would typically be established by a highly precise measurement system against which the device's tracking performance is compared. The specifics of this ground truth measurement system are not detailed beyond "state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy."
• Reprocessing: The ground truth for successful reprocessing would be the absence of contaminants and maintenance of device functionality after the specified reprocessing cycles, confirmed by established laboratory methods and standards.
• Electrical Safety: Compliance with ANSI/AAMI ES 60601-1 is the ground truth.

8. Sample Size for the Training Set:

The device is a physical medical instrument, not an AI model requiring a "training set" of data. Therefore, this information is not applicable.

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

As there is no training set, this information is not applicable.

Summary of Key Findings from the Document:

The 510(k) submission for the Instrument Clamps Electromagnetic relies on bench testing to demonstrate substantial equivalence to a predicate device.

• Accuracy testing was performed according to ASTM F2554, and the devices reportedly met "state-of-the-art acceptance criteria," but specific numerical performance values are not disclosed.
• Reprocessing validation complied with FDA guidance, TIRs, ISO 17665-1, and ANSI/AAMI ST79.
• Electrical safety compliance was certified to ANSI/AAMI ES 60601-1.
• No clinical testing was deemed necessary.
• The device is a physical instrument, not an AI/software product, so concepts like "test set sample size (for data)," "experts for ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not directly applicable in the context of the information provided.

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TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Curette (K201174), is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.

The TruDi™ Curette incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT/MRI scan to confirm access, and to locate anatomical structures during ENT and ENT skull base surgery.

The provided document is a 510(k) summary for the TruDi™ Curette, which seeks to demonstrate substantial equivalence to a predicate device. While it includes a lot of information about bench testing and design validation, it does not detail a study involving AI performance or human readers. Therefore, several requested sections, particularly those related to AI and human reader studies, cannot be extracted from this document.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Design validation testing (simulated use testing) on cadavers" but does not specify the sample size (number of cadavers or test cases) used for this test set nor the detailed provenance beyond "cadavers". It is a prospective study in a simulated clinical setting.

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

Not specified in the provided document. The document mentions "evaluators" for assessing packaging and instructions for use, but not for establishing ground truth regarding clinical performance.

4. Adjudication method for the test set

Not specified in the provided document.

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

Not applicable. The TruDi™ Curette is a physical surgical instrument, not an AI or imaging diagnostic device that would involve human readers or AI assistance in the way typically assessed by MRMC studies.

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

Not applicable. The TruDi™ Curette is a physical surgical instrument, not an algorithm. Its navigation capability is part of the TruDi™ Navigation System, which has a stated accuracy of ≤ 2mm RMS. This accuracy is a standalone measurement of the system's ability to track the instrument's tip.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the navigational location accuracy, the ground truth would typically be established through precise metrological measurements using a known standard or reference system. For the simulated use testing on cadavers, the "ground truth" or successful performance would be based on the device functioning as intended in manipulating, dissecting, and/or removing tissue, cartilage, and bone, as verified by the evaluators. Specific methods for establishing this ground truth (e.g., expert observation, quantitative assessment of tissue removal) are not detailed.

8. The sample size for the training set

Not applicable. The TruDi™ Curette is a physical device, and the document describes performance testing and design validation, not the development or training of an AI algorithm.

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

Not applicable. There is no mention of a training set or AI model in the context of this device.

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The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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.

This can include, but is not limited to, the following procedures:

• Functional Endoscopic Sinus Surgery (FESS)
• Endoscopic Skull Base procedures
• Lateral Skull Base procedures

The Medtronic SteathStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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.

The StealthStation FlexENT™ is an electromagnetic based surgical guidance platform that supports use of special application software (StealthStation™ S8 ENT Software 1.3 and associated instruments.

The StealthStation™ S8 ENT Software 1.3 helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. StealthStation™ S8 ENT Software 1.3 functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and traiectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, realtime positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide. The StealthStation™ S8 ENT v1.3 Software can be run on both the StealthStation FlexENT™ and StealthStation™ S8 Platforms.

The StealthStation™ System is an Image Guided System (IGS), comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states that "Testing was performed under the representative worst-case configuration... utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." It does not specify a numerical sample size for the test set (e.g., number of phantoms or trials).

The data provenance is not explicitly stated in terms of country of origin. The test appears to be a prospective bench study conducted by the manufacturer, Medtronic Navigation, Inc.

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

The document does not mention the use of experts to establish ground truth for this accuracy testing. The ground truth for positional and trajectory accuracy would typically be established by precise measurements on the anatomically representative phantoms using highly accurate measurement systems, not by expert consensus.

4. Adjudication Method for the Test Set:

Not applicable, as this was a bench accuracy test with directly measurable metrics, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not conducted. The study focuses on the standalone accuracy of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study was done. The accuracy testing described ("3D positional accuracy" and "trajectory angle accuracy") measures the device's inherent accuracy in locating anatomical structures and guiding trajectories, independent of human interaction during the measurement process. The system tracks instruments and displays their position and trajectory on images without direct human interpretation being part of the measurement for these accuracy metrics.

7. The Type of Ground Truth Used:

The ground truth used for this accuracy study was derived from precise physical measurements taken on "anatomically representative phantoms." This implies that the true position and trajectory were known and used as reference points against which the device's reports were compared.

8. The Sample Size for the Training Set:

The document does not provide information about a training set since the study described is a performance validation of a medical device's accuracy, not a machine learning model that would require a dedicated training set. The software likely undergoes extensive internal development and testing, but separate "training set" details are not provided in this context.

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

Not applicable, as no training set information is provided or relevant for this type of accuracy study.

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The TruDi™ Probe is intended for use with the TruDi™ Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed.

The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.

The document describes the Acclarent TruDi™ Probe, a single-use electromagnetically (EM) navigated instrument for locating anatomical structures during ENT and ENT skull base surgery. The device is intended for use with the TruDi™ Navigation System.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance data from various non-clinical tests. Since specific quantified acceptance criteria are not presented in a direct table format alongside the reported performance values, I will infer them from the descriptions.

2. Sample Size for Test Set and Data Provenance:

The document mentions "bench testing" and "simulated use testing on cadavers." However, specific sample sizes for these tests are not provided. The provenance of the data is implied to be from the manufacturer's internal testing as part of their 510(k) submission, and it is retrospective (performed before the submission). There is no mention of country of origin for the data; it is assumed to be part of the manufacturer's internal development and testing.

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

The document describes "simulated use testing on cadavers" where "packaging and instructions for use were also successfully assessed by evaluators." However, the number of experts and their qualifications used to establish ground truth for these tests are not mentioned.

4. Adjudication Method:

The document does not specify an adjudication method for the "simulated use testing" or any other performance evaluation involving human assessment.

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

A MRMC comparative effectiveness study was not conducted or reported. The submission explicitly states "Clinical data was not necessary for the TruDi™ Probe. The performance data demonstrated that the device performs as intended." This indicates no study was done to assess human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only):

The document describes the standalone performance of the device concerning its navigational accuracy:

• A mean bench accuracy of 0.43 mm (Standard deviation 0.15 mm) was measured for the device.
• With 95% confidence, measured devices have a location accuracy of ≤ 2 mm RMS over the entire navigation volume.
  This indicates algorithm-only performance testing for its core functionality (localization).

7. Type of Ground Truth Used (for standalone performance):

For the navigational accuracy, the ground truth would have been established by a highly precise engineering and metrology setup (e.g., using a known reference system or precision measurement tools) to determine the true position, against which the device's reported position was compared. This is typical for such electromagnetic navigation systems.

8. Sample Size for the Training Set:

The TruDi™ Probe is an electromagnetic navigation instrument, not an AI or machine learning algorithm in the typical sense that would require a "training set" of data to learn from. Its performance is based on physical principles and sensor technology. Therefore, a training set size is not applicable in this context.

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

As mentioned above, the concept of a "training set" and associated ground truth is not applicable to this device, which relies on direct physical measurement and not a learning algorithm.

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