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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, MR, or Xray.

The InstaTrak 3000 System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 with FluoroTrak is similar to the InstaTrak 3000 System cleared under K983529. The changes to the system include software enhancements and the addition of a calibration fixture. 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, cranial, 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 3000 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 images is accomplished through the registration process. 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 with FluoroTrak 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the InstaTrak 3000 System with FluoroTrak Module:

Unfortunately, the provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt. The document is a 510(k) summary for premarket notification, which focuses on establishing substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria and detailed statistical results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states "within the specification" but does not explicitly list the quantitative acceptance criteria (e.g., specific accuracy thresholds in millimeters) for location, surgical instrument position, or any other performance metric.

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

The document states: "Testing was performed using the new component of the InstaTrak 3000 with FluoroTrak to determine if the new component affected device accuracy."

Missing Information:

• Sample Size: The number of tests, cases, or subjects used for this testing is not mentioned.
• Data Provenance: There is no information about whether the data was prospective or retrospective, or the country of origin.

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

Missing Information: The document does not describe the methodology for establishing ground truth for the performance testing, nor does it mention the involvement or qualifications of any experts for this purpose.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method (e.g., 2+1, 3+1, none) is mentioned as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or implied in this document. This device is an image-guided surgical system, not an AI diagnostic tool that assists human readers in interpreting images.

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

The performance testing described focuses on the device (InstaTrak 3000 with FluoroTrak module) and its accuracy when using a new component. It is implied to be a standalone performance evaluation of the system, not specifically an algorithm-only study in the context of AI. The core function of the device is image guidance for a surgeon, so human-in-the-loop

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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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