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Z-Box is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

Z-Box is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

• Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
• Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
• ENT Procedures
• Orthopedic surgical procedure

The Z-Box System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Z-Box uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.

Z-Box will consist of following basic components:

• High Resolution color liquid crystal display (LCD) touch screen monitor
• Uninterruptible Power Supply (UPS)
• Central Processing Unit (CPU)
• Isolation Transformer
• Keyboard and Mouse
• Optical Detector (on wheeled-base pedestal)
• Operating Room Cart
• Tool and accessories surgical tools and accessories instrumented with LEDs or reflective markers
• dMIS kit surgical instrument kit containing IGS tools and accessories and dMIS key
• dMIS key electronic storage media containing disposable software application

This document is a 510(k) summary for the Z-Box Stereotaxic Instrument. It does not contain information about specific acceptance criteria, device performance metrics, or the details of a study that proves the device meets such criteria.

The document focuses on:

• Device Description: What the Z-Box is and its components.
• Intended Use: The clinical applications for which the Z-Box is designed.
• Substantial Equivalence: Claiming equivalence to a previously cleared device (Voyager Linux; Z-KAT, Inc., K023975).
• Regulatory Clearance: The FDA's letter granting clearance for the device.

Therefore, I cannot provide the requested information from the provided text. To answer your questions, I would need a different type of document, such as a clinical study report, a verification and validation report, or a more detailed technical specification.

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The Voyager is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide oxientation and reference information during intra-operative procedures.

The Voyager is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a tigid anatomical structure may be made, such as:

• . Intra-crania surgical procedures involving space occupying lessons or malformations (including soft tissue, vascular and osseous)
• Spinal surgical procedures involving spinal stabilization, neutal decompression, or ● resection of spinal neoplasms
• ENT Procedures .
• Orthopedic surgical procedures ●

The Voyager System is an image guided surgical device that includes an optical detector (infrared sensor), computer, dedicated instrumentation, and operating software. Voyager uses diagnostic images of the patient to assist the physician with presurgical planning and interpretive/interoperative navigation. Diagnostic image datasets describing internal and external patient anatomy or time sequences may be combined (superimposed) for comparison or to facilitate navigation during surgery.

The document provided is a 510(k) summary for the Z-KAT, Inc. Voyager Linux stereotaxic instrument. This type of regulatory document focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results or acceptance criteria for a new device's performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies cannot be fully extracted from the provided text. The document primarily describes the device, its intended use, and its substantial equivalence to an existing device (Voyager 6.0 Software Option; Marconi Medical Systems, K000310).

Here's what can be stated based on the provided text, and what cannot:

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

• Cannot be extracted. The document does not define specific performance acceptance criteria for the Voyager Linux device, nor does it report performance metrics against such criteria. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence in design, materials, and intended use as opposed to new clinical efficacy/performance trials against predefined criteria.

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

• Cannot be extracted. The document does not mention any specific test sets, sample sizes, or data provenance related to a performance study for the Voyager Linux device.

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)

• Cannot be extracted. No information is provided about experts used for ground truth establishment, as no test set or performance study is detailed.

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

• Cannot be extracted. No information about adjudication methods is provided, as no test set or performance study is detailed.

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

• Cannot be extracted. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance. The Voyager Linux is described as an image-guided surgical device, not an AI-driven diagnostic tool that would typically involve "human readers" in the context of interpretation.

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

• Cannot be extracted. The document does not describe any standalone performance studies. Given it's a "stereotaxic instrument" and "image guided surgical device," it inherently involves human interaction and is not an algorithm-only device.

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

• Cannot be extracted. As no performance study is described, no information on the type of ground truth used is available.

8. The sample size for the training set

• Cannot be extracted. The document does not mention any training sets, as it is not describing a machine learning or AI algorithm in the context of a new development or training process.

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

• Cannot be extracted. As no training set is mentioned, there is no information on how its ground truth was established.

Summary of available information:

• Device Name: Voyager Linux
• Predicate Device: Voyager 6.0 Software Option; Marconi Medical Systems, K000310
• Device Description: An image-guided surgical device including an optical detector, computer, dedicated instrumentation, and operating software. Uses diagnostic images for pre-surgical planning and intra-operative navigation.
• Intended Use/Indications: To assist physicians with presurgical planning and to provide orientation and reference information during intra-operative procedures for stereotactic surgery involving rigid anatomical structures. Specifically mentioned for:
  • Intra-cranial surgical procedures (space occupying lesions, malformations including soft tissue, vascular, osseous)
  • Spinal surgical procedures (stabilization, neural decompression, resection of spinal neoplasms)
  • ENT procedures
  • Orthopedic surgical procedures

In conclusion, the document serves its purpose as a 510(k) summary for substantial equivalence but does not provide the detailed performance study information requested.

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FluoroLab Plus will be used for navigational guidance to position instruments during surgical procedures. It will provide a method of navigational guidance of tools through the use of a standard C-arm fluoroscope to capture images and an optical camera for instrument tracking. This increase in control will free the surgeon from the iterative process conventionally used, reduce the length of the surgical procedure, and enable minimally invasive procedure. In addition, since only two fluoroscopic images are needed, the exposure to X-rays is greatly reduced.

FluoroLab Plus will be used to assist in the alignment of surgical instruments by providing the surgeon with intraoperative navigational guidance based on pre-acquired fluoroscopic images. Surgeon will use coordinated-fluoroscopy to allow intra-operative planning of the alignment of surgical tools such as a screw, nail, or needle.

FluoroLab Plus is an integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments using at least two captured fluoroscopic images. The acquired images are displayed on a flat panel monitor. Surgical tools and accessories are instrumented with LEDs or small reflective markers. Their positions and orientations are continuously tracked by an optical camera and updated in reference to the fluoroscopic images to provide constant navigational guidance to the target.

FluoroLab Plus will consist of following basic components:

1. Registration phantom
2. Calibration grid
3. Fluoroscopic image intensifier system (C-arm)
4. Computer workstation with monitor and video acquisition box
5. Ergonomic cart
6. FluoroLab Plus software application
7. Optical camera with Tool Interface Unit (TIU)
8. Tools and accessories surgical tools and accessories instrumented with LEDs or reflective markers

The provided 510(k) summary for the FluoroLab Plus device does not include explicit acceptance criteria, a detailed study report proving the device meets acceptance criteria, or information on human reader performance with or without AI assistance. The document is primarily a premarket notification for substantial equivalence.

However, based on the information provided, we can infer some details related to the device's characteristics and the submission process.

Here's an analysis based on the given text, noting when information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria (e.g., accuracy thresholds, precision targets, recall/precision metrics). Nor does it contain a table summarizing these criteria against reported performance data from a specific study. The submission focuses on substantial equivalence to predicate devices rather than presenting detailed performance validation against explicit criteria.

The "DESCRIPTION" and "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS" sections describe what the device does and what it consists of, but not quantitative performance criteria it must meet. The "Intended Use" section outlines the functional benefits (e.g., "more accurately position drill guides," "reduce the length of the surgical procedure," "greatly reduced [exposure to X-rays]"), but these are not quantified as acceptance criteria.

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

The document does not mention a test set sample size or detail the provenance of any data used for testing. The submission is a 510(k) for substantial equivalence, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trial data, especially for Class II devices like this stereotaxic instrument.

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

The document does not describe any expert-established ground truth or the number and qualifications of experts involved, as it does not detail a specific performance study or test set validation.

4. Adjudication Method for the Test Set

Since no specific test set or expert ground truth establishment is described, there is no mention of an adjudication method.

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

The device, FluoroLab Plus, is described as an "integrated system that helps a surgeon more accurately position drill guides, screw drivers, needles, and other surgical instruments." While it offers "navigational guidance," it is a tool for a surgeon, not an AI-powered diagnostic or assistive tool in the modern sense of "AI" (e.g., machine learning for image interpretation). Therefore, an MRMC study comparing human readers with and without "AI assistance" in the context of diagnostic interpretation is not applicable and not mentioned. The device augments a surgeon's ability to navigate tools, rather than enhancing human "reading" of images.

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

The device is inherently designed for "human-in-the-loop" performance, as it provides "navigational guidance" to a surgeon. It's not a standalone diagnostic algorithm. Therefore, a standalone (algorithm-only) performance study is not discussed and not applicable in the context of this device's function.

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

The document does not specify any type of ground truth used for performance evaluation, as it does not detail a specific performance study. Given the device's function (navigational guidance for instrument placement), ground truth would likely relate to the accuracy of tool placement relative to a target, based on physical measurements or imaging verification rather than expert consensus on a diagnosis, pathology, or outcomes data. However, no such study is presented.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This type of stereotaxic instrument, predating widespread use of deep learning AI, would typically be developed through engineering and calibration, not through training on a large dataset in the way a modern AI algorithm would be.

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

As no training set is described for an AI/ML context, there is no information on how ground truth for a training set was established. The "ground truth" for the device's functionality would be established through engineering specifications, calibration procedures, and accuracy testing in a controlled environment.

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The Fluorotactic Guidance System Mk. I will be used to assist in the accurate placement of a guiding device for surgery in which a linear trajectory insertion or placement is required. This system will use coordinated-fluoroscopy to allow intra-operative planning of the precise insertion point and angle of a device such as a screw, nail, or needle.

The surgeon will place a registration artifact over the desired surgical area and capture two fluoroscopic images, which will then be displayed on two computer screens. The surgeon will manipulate a virtual guidewire on the screens, until the desired angle and placement is achieved. The system will then output 3D coordinates to the robot arm which will move the drill guide to a precise position.

The Fluorotactic Guidance System Mk. I is an integrated system that enables a surgeon to more accurately position drill guides, screw drivers, needles, and other surgical instruments using two captured fluoroscopic images. An electromechanical arm is used to accurately position an end-effector over the desired surgical area, and two approximately orthogonal images are captured with a standard flouroscope. The two images are displayed on computer monitors and used to perform accurate intra-operative planning. The plan consists of specifying the instrument entry point, and sagittal and transverse orientations. The system will then calculate the necessary coordinates for the robot ann, which will position the drill guide over the surgical area.

The Fluorotactic Guidance System Mk. I system will consist of four components:

1. Robot arm
2. Registration/drill guide artifact
3. Fluoroscopic image intensifier system (C-arm)
4. Personal computer (PC) with a Data Translation image acquisition card and two monitors

The robot arm will hold a registration artifact which is transparent to X-rays over the patient in proximity to the desired surgical area. This artifact has eight steel balls embedded such that when the C-arm is used to capture images of the area, the balls will create fiducial shadows on the image. Two images will be required, an Anterior/Posterior (A/P) view and a Sagittal view.

The PC will receive the image data from the C-Arm and display it on two monitors. The surgeon will indicate the desired positioning of the drill by manipulating a virtual guidewire on the screens. The software will then use the fiducial location information to calculate the coordinates for the positioning of the drill guide, and the robot arm will move to the new orientation.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Z-KAT Fluorotactic Guidance System Mk. I, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting the results of a specific performance study against pre-defined acceptance criteria.

However, based on the description of the device and its intended use, we can infer the types of performance criteria that would be relevant for such a system. The core function is the "accurate placement" of surgical instruments using "coordinated-fluoroscopy" and a "robot arm" to achieve a "precise position." Therefore accuracy would be the primary metric.

Here's a hypothetical structure of the requested information, acknowledging that the specific values and study details are not present in the provided text and would need to be synthesized or assumed for a complete answer.

Inferred Acceptance Criteria and Hypothetical Performance Study (Based on device description)

Given that the Z-KAT Fluorotactic Guidance System Mk. I is designed to assist in the "accurate placement of a guiding device for surgery," the primary acceptance criterion would relate to the accuracy of instrument positioning.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: (Hypothetical) 50 simulated surgical scenarios involving phantom models.
• Data Provenance: (Hypothetical) Prospective study conducted in a laboratory setting, using standardized phantom models designed to mimic human anatomy (e.g., bone structures for drill guide placement). The phantoms would be representative of various surgical sites where the device might be used (e.g., spinal, orthopedic).

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

• Number of Experts: (Hypothetical) 3
• Qualifications of Experts: (Hypothetical) Board-certified orthopedic surgeons or neurosurgeons, each with at least 15 years of experience in image-guided surgery techniques and familiar with stereotactic principles. They would be involved in defining the "desired" or "true" surgical trajectory on the phantom models.

4. Adjudication Method for the Test Set

• Adjudication Method: (Hypothetical) Expert Consensus (None in the typical 2+1, 3+1 sense as it's a technical accuracy study). In this type of technical accuracy study, the "ground truth" for the desired trajectory is established a priori by the engineering team and validated by the expert surgeons. The deviation of the device's output (robot arm position) from this pre-defined ground truth is directly measured. If there were discrepancies in how the "desired trajectory" was established by experts, a consensus meeting would be used to reconcile differences.

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

• MRMC Study: (Hypothetical) No, not explicitly stated or implied for this submission. The FDA 510(k) summary focuses on the technical capability and safety of the device itself, comparing it to predicate devices. A MRMC study would typically evaluate the impact of the human-in-the-loop performance (i.e., how surgeons using the system perform compared to surgeons without it), which is usually beyond the scope of an initial 510(k) for a guidance system.

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

• Standalone Performance: (Hypothetical) Yes, the described accuracy metrics (Linear and Angular Trajectory Placement Accuracy) would represent the standalone performance of the system. The device's ability to precisely position the robot arm based on the surgeon's virtual guidewire manipulation and the system's independent calculation would be measured. The human input (surgeon moving the virtual guidewire) is an input to the system, but the output (robot arm position) is a function of the system's accuracy in executing that input based on image processing and robotic control.

7. The Type of Ground Truth Used

• Ground Truth Type: (Hypothetical) Precision-machined phantom models with known fiducial marker locations and predefined target trajectories. The "true" or "desired" trajectory would be engineered into the phantom with high precision, allowing for direct measurement of the deviation of the system's placement from this known truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: (Hypothetical) The document does not describe AI/machine learning components that would typically require a training set for its core guidance function (image registration, robot control). If the system did employ such components (e.g., for automated anatomical landmark recognition), the training set size would be: Not Applicable (or not specified for this device's core functionality as described). If there were internal software models (e.g., for optimal C-arm placement, or image enhancements), those might have been developed using various fluoroscopic images, but this isn't explicitly mentioned for a "training set" of a machine learning model.

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

• Ground Truth for Training Set: (Hypothetical) Not Applicable, as no explicit machine learning training set is described for the core guidance function. If AI/ML components were later introduced, ground truth would likely be established through:
  • Manual annotation by multiple experts: Experts would delineate structures, identify landmarks, or classify image features on a large dataset of fluoroscopic images.
  • Consensus from multiple (e.g., 3-5) highly experienced radiologists/surgeons, followed by majority vote or arbitration in cases of disagreement.
  • Pathology or high-resolution imaging correspondence for anatomical landmark ground truth.

Disclaimer: The information in this response beyond what is directly stated in the provided 510(k) summary is hypothetical and based on common practices for evaluating medical guidance systems. The actual acceptance criteria and study details would be specific to Z-KAT's internal design validation and verification processes.

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