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Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows:

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostialethmoid infundibula in patients 2 years and older;

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostialrecesses in patients 12 years and older: may be used with LED Light fiber to locate, illuminate across nasal and sinus structures;

· Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older;

• Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.

The SINUSPRIME Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. Each packaged SINUSPRIME System includes a balloon device configured for a specific anatomy (frontal, sphenoid, maxillary, or Eustachian tube (ET) configuration) and an inflation device. The SINUSPRIME Dilation System combines features of an ostium seeker with the tissue expansion effect of balloon dilation. The SINUSPRIME Dilation System is provided sterile and for single use only. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. The SINUSPRIME LED Light Fiber consists of a flexible illumination fiber that allow physicians to locate, illuminate within, and trans-illuminate across nasal and sinus structures. The SINUSPRIME LED Light Fiber is optional and available packaged and pre-loaded only on the SINUSPRIME Frontal with LED model.

The provided text is a 510(k) summary for the Stryker ENT SINUSPRIME Dilation System. It outlines the device, its indications for use, technological characteristics, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, device performance, study design, or ground truth establishment for an AI-based device.

The document discusses "Performance Data" but only states: "Performance testing involved biocompatibility, design verification (dimensional, strength, HFE/UE verification testing), packaging, shelf life and design validation with physicians (HFE/UE). Performance testing showed that the device meets design specifications and performs as intended." This refers to engineering and human factors testing for a physical medical device, not a study involving AI algorithm performance with a test set, expert readers, or ground truth in the context of diagnostic or prognostic capabilities.

Therefore, I cannot provide the requested information from this document. The SINUSPRIME Dilation System is a physical medical device (balloon catheter for dilation), not an AI/ML-based diagnostic or imaging device. The questions you've asked are typically relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, AUC, or reader agreement are crucial for regulatory submission.

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The TGS Guidewire 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:

• · Transsphenoidal 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 TGS Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for use with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System during balloon sinus dilation procedures.

The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The TGS Guidewire is a single use, sterile, disposable instrument intended to be used with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System. The instrument is an electromagnetically navigated device which consists of a sensor in a protective sheath that can be inserted into the working lumen of the XprESS device, a bayonet connector to secure the device to the XprESS luer and a cable and plug to connect the device to the navigation system. The navigation system displays the position of the instrument in the preoperative scans.

The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The provided text describes a 510(k) premarket notification for the TGS Guidewire and updated Scopis Software. It details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML component, a clinical study with a test set, ground truth establishmet, expert review, or MRMC studies. The document primarily focuses on demonstrating the substantial equivalence of the TGS Guidewire and updated Scopis Software to existing predicate devices through performance testing, rather than an AI/ML algorithm's performance against specific acceptance criteria in a robust clinical study.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable based on the provided text.

Here is a breakdown of the available and missing information based on your request:

1. A table of acceptance criteria and the reported device performance

The document mentions "Navigation accuracy" as a key performance metric for the TGS Guidewire. While it reports the device's performance, it does not explicitly state an acceptance criterion for this navigation accuracy. It implicitly uses the predicate device's performance as a benchmark for substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable/Not mentioned. The performance data discussed is from "bench testing," not a clinical test set involving patient data.
• Data Provenance: Not applicable/Not mentioned for a clinical test set. The data is from internal bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" for navigation accuracy in bench testing would likely be based on precise measurement instruments, not expert human review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring adjudication.

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. There is no mention of a multi-reader multi-case study, nor an AI component where human readers would interact with AI. The device is a "Stereotaxic Instrument" and software for navigation, not an AI diagnostic tool.

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

Not applicable. The device is a hardware guidewire used in conjunction with a navigation system and software, implying human interaction, not a standalone algorithm performing a task without human intervention. The "navigation accuracy" measured is for the combined system's ability to locate anatomical structures.

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

For the navigation accuracy, the "ground truth" would be established by the precise measurement setup and instrumentation used in the bench testing. No clinical ground truth methods like expert consensus, pathology, or outcomes data are mentioned.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/ML device that requires machine learning training data.

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

Not applicable, as there is no training set mentioned.

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The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, 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 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:

• · Transsphenoidal 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 TGS Universal Headrest with Mounting Arm is a reusable device intended to be used with the Stryker ENT Navigation System. It consists of three main components: a headrest, mounting arm and chair adapters. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an optimal electromagnetic field. The headrest provides support for the patient's head while undergoing navigation guided procedures. The chair adapters are fixed to the headrest to allow the headrest to various ENT procedure chairs

Here's an analysis of the acceptance criteria and study information for the TGS Universal Headrest with Mounting Arm, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.

Acceptance Criteria and Reported Device Performance

The provided document describes the TGS Universal Headrest with Mounting Arm as a reusable accessory to the Stryker ENT Navigation System. The performance data focuses on demonstrating that the device meets its design specifications and functions as intended, rather than clinical efficacy metrics typically associated with diagnostic or therapeutic devices.

Study Information Table (if applicable, N/A otherwise)

Summary and Key Takeaways for this Device:

The TGS Universal Headrest with Mounting Arm is a mechanical accessory for an existing navigation system. Its clearance is based on demonstrating substantial equivalence to predicate devices and proving that it performs its intended ergonomic and functional roles. The "study" for this device primarily consisted of:

• Bench testing: Verifying that the device meets its dimensional, functional, compatibility, and distribution specifications.
• Simulated use testing: Confirming that the device operates as expected during mock procedures.
• Design validation with user feedback: Ensuring that ENT physicians (intended users) can successfully perform critical tasks with the device in its expected use environment.

This type of device does not involve complex clinical trials, statistical performance metrics for diagnostic accuracy, or AI/ML algorithm evaluation. Therefore, many of the detailed questions regarding expert adjudication, ground truth, and AI-specific study designs are not relevant.

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