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The Fiagon Navigation – Extended Instrument Set ENT is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The Fiagon Navigation - Extended Instrument Set ENT 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, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access.

The Fiagon Navigation - Extended Instrument Set ENT are reusable instruments intended to be used with the Fiagon Navigation system. The instruments in the Set are electromagnetically navigated devices that are

• Navigated suction instruments (malleable, designed to be bendable by hand, sensor a. within the tip, attachable to standard surgical vacuum suction systems)
• b. Navigated pointing devices (flexible, sensor within the tip)
• c. Registration probe (designed for non.sterile patient registration)
• d. Instrument adaptors (designed for mechanical connection to cylindric schaped surgical instruments of different diameters)

Each device incorporates a sensor device which is tracked by the navigation system with in the low-energy magnetic field of a field generator (part of the navigation system)

The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy)

Here's a breakdown of the acceptance criteria and study information for the Fiagon Navigation - Extended Instrument Set ENT, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state formal "acceptance criteria" in a numerical target format (e.g., "accuracy must be less than X mm"). Instead, it compares the device's performance to that of its predicate devices. The implied acceptance criterion is that the new device's accuracy should be comparable to or better than the predicate devices, specifically remaining under 2mm at the 95% confidence level.

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ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.

The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.

The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.

The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.

Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.

The K053610 submission for ABARIS describes a computer-assisted image-guided surgery system. The submission does not contain a study to prove acceptance criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices. It states that "The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices."

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The submission is a 510(k) premarket notification, which often demonstrates substantial equivalence rather than presenting new clinical study data with explicit acceptance criteria. The FDA's letter (APR 19 2006) confirms this by stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

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The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities. The device may also be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck. Additionally, the device may be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.

The Hummer Trak System can be sub-divided into two systems, the handpiece and the power unit. The power unit is placed in a secure position, permitting the handpiece to access the surgical site. The power unit contains a motor that drives the handpiece via a flexible drive shaft. Slots are cut in the body of the power unit, permitting lashing straps to secure the unit. The power unit is connected to the TPS Console (K942956 and K943563/S2). The handpiece is mechanically driven from the power unit via the flexible drive shaft. The handpiece effectively transmits the motor energy of the power unit to the shaver blade or bur attachment. A slot is cut longitudinally along the circumference of the handpiece body, securing irrigation tubing. A ball-type valve is provided to regulate suction from the shaver blade or bur attachment. Suction tubing is connected to the handpiece utilizing a suction fitting. A quick release trinkle-type mechanism is used to secure shaver blade and bur attachments. A receiver mount is located on the upper portion of the handpiece body, allowing an image guided sensor to be secured. The InstaTrak image guided sensor is secured to the handpiece by means of a receiver mount. The mount holds the sensor in place by engaging a notch within the sensor and a Delrin latch. The sensor provides three dimensional visualization of the shaver blade or bur attachment's precise location. Small magnets embedded within the receiver mount identify the handpiece as a probe type to the image guided surgery system. Two physical interlocks ensure that calibration is performed when required. Removal of the image guided sensor triggers recalibration when the magnets are no longer detected. Additionally, a mechanical arm connected to the locking mechanism shifts the magnets, creating an intermittent signal loss, forcing recalibration.

The provided text is a 510(k) summary for the Stryker Hummer Trak System, a medical device. It does not describe acceptance criteria for a study, nor does it present any study data demonstrating the device meets performance criteria.

Instead, the document details:

• Device identification: Proprietary name (Hummer Trak), common name (Electrical surgical shaver with irrigation), and classification.
• Equivalence claim: States the Hummer Trak System is equivalent to the Hummer II Microdebrider System (K952681 and K972584).
• Description: Explains the components (handpiece, power unit), how they work, and the integration of an image-guided sensor.
• Intended Use: Specifies its application in Functional Endoscopic Sinus Surgery (FESS) for tissue excision, endoscopic/open plastic, reconstructive, and aesthetic surgery of the head and neck, and its use with the VTI InstaTrak image-guided system.
• Technological Comparison: Highlights differences from the predicate device (Hummer II Microdebrider System), primarily concerning integration with image-guided surgery sensors (minimizing electromagnetic materials, flexible drive shaft) and minor design changes to the suction mechanism.
• Standards: Mentions that both devices will be tested to IEC 601-1, CSA 601.1, UL 2601, IEC 601-1-2, and MDD 93/42/EEC for safety and compliance.
• FDA Clearance Letter: A letter from the FDA confirming substantial equivalence and allowing the device to be marketed.

Therefore, I cannot provide the requested information (acceptance criteria table, study details, sample sizes, ground truth information, MRMC study details) because it is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than presenting a performance study with specific acceptance criteria and results.

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The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

The InstaTrak System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 is essentially identical to the InstaTrak System cleared under K960330 and the Pediatric InstaTrak System cleared under K981998 which are both indicated for use during sinus surgery. The changes to the system include a computer upgrade, software enhancements, additional indications and the addition of several components. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures. The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base or axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user. The original InstaTrak System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through either an automatic or fiducial registration. The indications for use include sinus cleared under K960330 and pediatric sinus surgery (K981998). In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor. A newer version of a Sun computer has been substituted to provide 3D display capability which includes 3D models and planar images on top of 3D models, oblique and trajectory matching views. Additionally, a surgical planning capability has been added. This allows the surgeon to plan a trajectory prior to surgery and to observe the pre-surgical track in relation to the actual track during the surgical procedure. A new registration technique has been added whereby the surface of the anatomy can be registered to. New instruments have been added to which tracking sensors have been built in or may be attached. These, along with the surface registration and the new displays allow the system to be used in the proposed indications encompassing axial skeletal, and cranial surgery, in addition to the cleared and pending indications.

The InstaTrak 3000 is an image guidance system that aids surgeons in locating anatomical structures during surgical procedures. The provided 510(k) summary (K983529) describes the device and its claimed substantial equivalence to predicate devices. However, the summary does not contain detailed information regarding the specific acceptance criteria or a comprehensive study report with quantitative performance metrics as typically expected for medical device evaluations.

Based on the provided text, here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary lacks a formal table of acceptance criteria and reported numerical device performance metrics. The performance testing mentioned is qualitative and focuses on a specific aspect:

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

The 510(k) summary does not specify the sample size used for the performance testing. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to have been conducted internally by the manufacturer ("Testing was performed...").

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The 510(k) summary does not mention the use of experts to establish ground truth for any test set, nor does it detail their qualifications. The testing described focuses on the device's accuracy with new components, implying a technical evaluation rather than a clinical one involving expert consensus on patient data.

4. Adjudication Method for the Test Set

Since the summary does not detail the use of experts or a clinical test set, an adjudication method (like 2+1, 3+1) is not applicable and not mentioned.

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

The 510(k) summary does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no mention of comparing human reader performance with or without AI assistance, or any effect size of such improvement.

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

The InstaTrak 3000 is an "image guidance system" intended to "aid the surgeon." This inherently implies a human-in-the-loop device. Therefore, a standalone (algorithm-only) performance study as typically understood for diagnostic AI devices is not described and would likely not be the primary evaluation method given the device's nature. Its function is to provide information to a human operator.

7. Type of Ground Truth Used

The type of "ground truth" for the performance testing mentioned appears to be related to the "device accuracy" with new components. This would likely involve engineered or laboratory-based measurements against known physical parameters or standards, rather than clinical ground truth like pathology, expert consensus, or outcomes data. The summary does not specify the exact nature of this "specification" or how accuracy was measured against it.

8. Sample Size for the Training Set

The 510(k) summary does not provide information regarding a training set or its sample size. This is a premarket notification for a navigation system, not a machine learning or AI-driven diagnostic algorithm that typically relies on extensive training data. While the system has "software enhancements," the summary primarily emphasizes its technological similarity to predicate devices and the function of new components.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

Summary of Study Described:

The study referenced in the 510(k) summary (Section 7, "PERFORMANCE TESTING") was a limited internal validation focused on the new components of the InstaTrak 3000 System.

• Objective: To determine if the newly added components (nasal specula, mouth gag, pharyngeal retractor, straight extended aspirator, sterile disposable pointer, transmitter, receiver, and head frame) affected the device's accuracy.
• Methodology (implied): The new components were incorporated into the system, and accuracy tests were performed.
• Results: The manufacturer concluded that "the device performed within the specification while using the new components."
• Limitations (from the provided text):
  • No quantitative accuracy metrics are provided.
  • The "specification" against which performance was measured is not defined.
  • No details on the number of tests, test conditions, or specific methodology are given.
  • The testing was not a clinical trial with patient-specific ground truth or human reader evaluations.

In essence, the 510(k) summary confirms that a technical performance test was conducted to ensure the new hardware components did not degrade the system's accuracy, based on the manufacturer's internal specifications. It does not provide the detailed evidence typically found in studies for AI-driven diagnostic devices, which often involve large datasets, expert ground truth, and comprehensive statistical analysis of clinical performance measures. The substantial equivalence argument primarily relies on the core technology being largely identical to predicate devices.

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