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"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

The provided document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the "POINT" Kinguide Agile Hybrid Navigation System to previously cleared devices. It outlines the device's indications for use, a comparison to predicate devices, and lists various performance tests and compliance with standards.

However, the document does not contain the specific acceptance criteria for system performance beyond general accuracy expectations, nor does it detail the methodology or results of a study that directly proves the device meets these criteria. It refers to verification and validation results and reports overall accuracy figures, but the granular details expected for a comprehensive study description are absent.

Therefore, much of the requested information cannot be directly extracted from the provided text.

Here is an attempt to address your request based on the available information from the document, with clear indications where the information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document states a system accuracy requirement and reports the performance. While it doesn't explicitly frame these as "acceptance criteria" for a specific study, these are the performance targets the device demonstrated.

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

• Sample Size for Test Set: Not specified. The document mentions "verification and validation results" and "Non-clinical Performance (Accuracy)" and "Cadaveric Validation Report," but it does not provide the sample size (e.g., number of cases, number of anatomical structures, number of screws tested) for these studies.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not specified. The document does not provide details on the origin of the data or the study design (retrospective or prospective). The company's address is in New Taipei City, Taiwan, suggesting the studies might have been conducted there, but this is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document does not mention the use of experts for establishing ground truth in the context of these performance tests. The performance assessments appear to be based on physical measurements and system capabilities rather than human expert assessment of images.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

• Adjudication Method: Not applicable/Not specified. The tests described (positional and trajectory accuracy) are objective engineering and performance measurements, not typically requiring human adjudication in the way medical image interpretation might. The document does not mention any form of adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• MRMC Study: No, a MRMC comparative effectiveness study was not done or described. This device is a surgical navigation system, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Its "performance" relates to its ability to accurately track and guide surgical instruments.
• Effect Size of Human Reader Improvement: Not applicable. As no MRMC study was done, this information is not provided.

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

• Standalone Performance: Yes, implicitly. The reported "System Accuracy Requirement" and "Non-clinical Performance (Accuracy)" (mean accuracy of $\leq$ 2.0 mm for location error and $\leq$ 2.0° for trajectory angle error) appear to be measurements of the device's inherent accuracy, likely in a controlled, non-human-in-the-loop setting (e.g., phantom studies, cadaveric studies without surgical intervention by humans as the primary variable). The "Cadaveric Validation Report" and "Compatibility and Measuring Accuracy Verification Report" suggest standalone performance testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for positional and trajectory accuracy would primarily be established through physical measurements against known standards or reference points (e.g., using a precisely calibrated phantom or a CMM - coordinate measuring machine). The "Cadaveric Validation Report" implies real anatomical structures were used, where the "ground truth" for screw placement or trajectory would be derived from post-procedure imaging (e.g., CT scans) analyzed against planned trajectories and positions. It does not mention expert consensus readings or pathology.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a navigation system, not a machine learning or AI model that requires a "training set" in the conventional sense of image data for model learning. The navigation algorithm uses transformation matrices, which are mathematical calculations based on tracking data, not a learned model from a large dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable. As explained above, there is no "training set" for a machine learning model, and thus no ground truth establishment for such a set. The accuracy of the system's underlying mathematical algorithms and optical tracking mechanism is verified through engineering tests.

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Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM 4.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™ 4.5, EXPEDIUM™ 5.5, EXPEDIUM™ 6.35, VIPER™ 2, VIPER™ SAI, VIPER PRIME™, EXPEDIUM VERSE™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

This document is a 510(k) premarket notification for the "TriALTIS Navigation Enabled Instruments". It's a regulatory submission to the FDA, not a study report detailing AI/algorithm performance. Therefore, most of the information requested in your prompt (acceptance criteria for AI, study details like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the physical device, its intended use, and confirms that its technological characteristics (design, materials, performance) are consistent with the predicates.

Here's a breakdown of what can and cannot be answered from the provided text:

Information NOT available in this document regarding AI/algorithm performance:

• 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm): This document does not describe performance metrics or acceptance criteria for an AI or algorithm. It's for a physical medical instrument.
• 2. Sample size used for the test set and the data provenance: Not applicable, as there's no AI algorithm being tested in the traditional sense.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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. This device is a navigation instrument, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide, related to its "performance" (as a physical device):

The document mentions "Performance Data" in Section I, but this refers to engineering analyses and compatibility testing for the physical instrument, not an AI algorithm.

• Acceptance Criteria Mentioned (for the physical instrument's performance):

  • Rigidity of Connections and Instrument During Use
  • Instrument Verification
  • Accuracy Verification

• Study described that proves the device meets these criteria:

  • Type of Study: "A dimensional comparison and engineering analysis demonstrates that the TriALTIS Navigation Enabled Instrument meet performance requirements..."
  • Compatibility Testing: "Compatibility testing was performed with Medtronic StealthStation System S8 using StealthStation Spine Software Version 1.2.0 (1.2.0-20) using automatic intraoperative 3D Scan on an OARM Imaging System according to set up and installation instructions outlined in Medtronic's StealthStation S8 Spine with O-arm and 3D Fluoro Imaging Pocket Guide."

• Sample Size: Not specified for the engineering analysis or compatibility testing in terms of "cases" or "patients." It's likely component-level testing or a few test runs with the integrated system.

• Data Provenance: Not explicitly stated (e.g., country of origin), but it would be laboratory/engineering test data.

• Ground Truth: For a physical instrument, ground truth would be established through engineering specifications, calibrated measurement tools, and functional success/failure in controlled test environments. This isn't the same as clinical diagnostic ground truth.

In essence, the prompt's questions are designed for a submission involving an AI/Machine Learning device, whereas this document pertains to a physical surgical navigation instrument.

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"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

The "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Specifically, it is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

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 specific sample size used for the test set for the accuracy verification. It mentions a "Cadaveric Validation Report," suggesting that testing was performed on cadaveric specimens, which would be retrospective data. The provenance (country of origin) of this data is not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device is a "Kinguide Agile Hybrid Navigation System," which is an image-guided system for surgical navigation, not an AI-assisted diagnostic tool that would typically involve human reader studies for comparative effectiveness.

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

Yes, a standalone performance evaluation of the device's accuracy was conducted. The "Non-clinical Performance (Accuracy)" section specifically states: "The system has a mean accuracy of ≤ 2.0 mm for location error and ≤ 2.0° for trajectory angle error." This refers to the intrinsic accuracy of the navigation system itself, independent of human interaction during the measurement process, aside from the initial setup and data acquisition.

7. The Type of Ground Truth Used:

The ground truth for the positional and trajectory accuracy would have been established through precise measurements using a highly accurate reference system (e.g., a calibrated measurement device or a pre-defined anatomical landmark with known coordinates) during the "Performance and Accuracy Verification Report" and "Cadaveric Validation Report." This is typically a technical ground truth rather than expert consensus or pathology.

8. The Sample Size for the Training Set:

The document describes the device as an image-guided navigation system and does not explicitly mention "training set" in the context of machine learning or AI models with distinct training phases. Therefore, no information is provided regarding the sample size for a training set.

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

As the document does not discuss a training set in the context of machine learning, it also does not elaborate on how ground truth for such a set would have been established. The core technology lies in optical positioning and image-to-patient registration, not typically in a machine learning model that requires a distinct training phase in the same way a diagnostic AI would.

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The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.

The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.

The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.

The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.

The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.

Navigation instrumentation consists of a navigated surgical probe and a patient reference.

The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.

The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.

The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.

The provided text describes the nView s1 with nav option, a mobile fluoroscopic C-Arm imaging system with navigation capabilities. The 510(k) summary focuses on demonstrating substantial equivalence to a previously cleared predicate device (nView s1 with nav option, K211064) and a reference device (Medtronic Navigation Inc - StealthStation™ S8 system, K162309).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

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

The document primarily focuses on demonstrating equivalence rather than explicitly listing acceptance criteria with detailed success/failure values for all performance characteristics. However, it does state specific performance criteria for Registration Accuracy and Clinical Accuracy.

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The Anatase Spine Surgery Navigation System is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.

Example procedures include but are not limited to:

Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.

The Anatase Spine Surgery Navigation System, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets is categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.

The modified Anatase Spine Surgery Navigation System, the subject of these 510(k) applications, introduces software, hardware and instruments modifications to the original Surgery Navigation System cleared in 510(k) K180523.

The Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-Spine2-V, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify sample sizes for any test sets nor the data provenance (e.g., country of origin, retrospective/prospective). The studies are non-clinical, meaning they did not involve patient data.

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

This information is not provided in the document as these were non-clinical tests.

4. Adjudication method for the test set:

This information is not provided in the document as these were non-clinical tests.

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 clinical testing, including MRMC studies, was conducted. The document explicitly states: "No clinical testing has been conducted."

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

The provided information focuses on the entire system's performance, which is an image-guided navigation system that would inherently involve human interaction (a surgeon). While software verification and validation were performed, the document does not distinguish between human-in-the-loop and algorithm-only performance for a standalone assessment in a manner that would typically be seen for an AI diagnostic device. The "Accuracy" test implies an assessment of the system's ability to track and display positions, which is a standalone performance metric for the navigation component, but it's not described as an AI-specific algorithm performance.

7. The type of ground truth used:

For the accuracy testing, the ground truth would likely be established through precise physical measurements to determine the true positional accuracy of the system against a known standard. However, the document does not specify the exact methodology for establishing the ground truth beyond referencing ASTM F2554-18. For other tests like electrical safety, EMC, and sterilization, the "ground truth" is defined by compliance with the referenced standards.

8. The sample size for the training set:

As this is a navigation system and not explicitly an AI diagnostic device in the context of machine learning model training, the concept of a "training set" in that sense is not directly applicable or discussed in the document. Software verification and validation were performed, but details on data used for these processes are not provided.

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

Same as above, the concept of a "training set" with established ground truth as typically understood in AI/machine learning is not applicable here. Software verification and validation would use various testing methods to ensure the software performs as designed and meets requirements.

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The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.

The nView sl is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.

The nView s1 with navigation option is intended as a navigation system to aid in pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.

The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile units: a mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking markers. The tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.

The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.

Navigation instrumentation consists of a navigated surgical probe and a patient reference.

The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device provides both real-time image capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.

The provided text does not contain detailed information about a study proving the device meets specific acceptance criteria in a quantitative manner (e.g., sensitivity, specificity, or specific error rates with confidence intervals). Instead, it discusses the device's conformance to various medical device standards and guidance documents, as well as a comparison to predicate devices, to demonstrate substantial equivalence.

However, based on the text, we can infer some "acceptance criteria" related to performance characteristics and the device's adherence to standards. The document primarily focuses on demonstrating substantial equivalence to predicate devices.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since specific quantitative performance acceptance criteria (e.g., accuracy thresholds for diagnostic tasks) and corresponding reported performance metrics (e.g., measured sensitivity, specificity) are not explicitly stated in the provided document, I will infer the "acceptance criteria" from the comparison attributes to predicate devices and the clinical accuracy stated for the navigation option. The "reported device performance" will be the values specified for the proposed device itself.

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

The document does not specify a sample size for any clinical test or test set, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective nature) for performance evaluation. The "Summary of non-clinical test data" mentions "Non-clinical tests were conducted on the subject device during product development" and "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." However, no numbers or details on the nature of these tests are provided.

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

The document does not mention any details regarding experts used to establish ground truth or their qualifications. The evaluation of the device appears to be based on engineering verification and validation, and comparison to predicate devices, rather than a clinical study requiring expert ground truth for specific diagnostic or interventional tasks.

4. Adjudication Method

No information is provided regarding an adjudication method. This is expected given the lack of specific details about a clinical study involving human readers or expert panels.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. The device is a navigation and imaging system, not an AI-assisted diagnostic tool in the sense that would typically warrant such a study.

6. Standalone Performance Study (Algorithm Only)

The document does not explicitly describe a standalone algorithm-only performance study. The core function of the device is to generate images and provide navigation guidance based on those images for human use during surgery. The performance metrics (e.g., 3D positional accuracy) are related to the system's ability to accurately localize, which is part of its integrated design.

7. Type of Ground Truth Used

Based on the nature of the device (imaging and navigation system for surgical procedures) and the limited information provided, the ground truth for the stated accuracy claims (positional and angular accuracy) would typically be established through phantom studies or cadaveric models using known, precise measurements as ground truth, validated against physical markers or reference systems. However, the document does not explicitly state the type of ground truth used for these specific measurements, only that "non-clinical tests were conducted" and "Testing for verification and validation for the device was found acceptable."

8. Sample Size for the Training Set

The document does not specify a training set sample size. This is not applicable in the context of the information provided, as the submission focuses on hardware and integrated software for imaging and navigation, not a machine learning model that would typically require a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied for a machine learning model, this information is not applicable and therefore not provided in the document.

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Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, VIPER PRIME®, EXPEDIUM VERSE®, and SYMPHONYTM OCT screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

The provided FDA 510(k) summary for the "Navigation Enabled Instruments" (K200791) describes the device, its intended use, and a performance study. However, it does not contain the detailed acceptance criteria or the specific results in a format that would allow for a direct numerical comparison as requested in your prompt.

Specifically, the document states that "Simulated Use testing was performed" and lists what this testing aimed to demonstrate, but it does not provide:

• A table of quantitative acceptance criteria (e.g., specific accuracy thresholds)
• The reported device performance against those criteria (e.g., measured accuracy values)
• Sample sizes for test sets (it mentions "clinically relevant anatomical specimen / model" but not the number)
• Data provenance (country of origin, retrospective/prospective)
• Number/qualifications of experts for ground truth
• Adjudication method
• MRMC study information
• Standalone performance data
• Type of ground truth used (beyond "anatomical specimen / model")
• Sample size for training set
• How ground truth for the training set was established

Key information that can be extracted from the provided text, related to the performance study, is as follows:

1. Acceptance Criteria and Reported Device Performance:

The document describes the objectives of the simulated use evaluation, which implicitly define the areas for which performance must be acceptable. However, it does not state specific numerical acceptance criteria or the reported device performance against them.

• Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity). |
  | Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification). |
  | Navigation Enabled Instruments can be accurately navigated, and screws accurately placed. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification). |

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

• Sample Size: The document mentions "a clinically relevant anatomical specimen / model." It does not specify the number of specimens/models used or the number of trials/measurements performed.
• Data Provenance: The study was a "Simulated Use testing," implying it was conducted in a controlled environment, likely at the manufacturer's facility. No information on country of origin of data, or whether it's retrospective or prospective is provided, though based on "simulated use," it's prospective testing.

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

• This information is not provided in the document. The ground truth would likely be established by the physical properties of the "anatomical specimen / model" and the known dimensions/placement attempts, but expert involvement for ground truth definition is not mentioned.

4. Adjudication method for the test set:

• This information is not provided in the document. Given it's a simulated use test on a model, formal adjudication as seen in clinical trials with human data is unlikely to be described here.

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 MRMC comparative effectiveness study is mentioned. The device is a navigation system for surgical instruments, not an AI-assisted diagnostic or interpretive tool that would typically involve "human readers" in this context. The evaluation focuses on the instrument's performance, not human reader improvement.

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

• The device inherently involves human-in-the-loop, as they are "Navigation Enabled Instruments" intended to "assist the surgeon." Therefore, a "standalone algorithm only" performance study is not applicable or described for this type of device. The simulated use testing inherently includes the human (or simulated human interaction) with the system.

7. The type of ground truth used:

• "Clinically relevant anatomical specimen / model." This typically refers to cadaveric specimens or realistic physical models that mimic human anatomy. The ground truth for accuracy would be based on the known anatomical landmarks or pre-defined target locations within these models.

8. The sample size for the training set:

• This information is not provided. This device is largely mechanical and optical (for navigation) rather than a machine learning/AI device that typically requires a discrete "training set" in the conventional sense. Its "training" would be through engineering design, calibration, and predicate device experience.

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

• This information is not provided, and as noted above, a formal "training set" and its ground truth establishment, as understood in AI/ML contexts, is not explicitly documented for this type of medical device in this summary.

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The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.

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

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The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

The provided text describes the Medtronic Stealth Autoguide System and Midas Rex Legend Depth Stop System. It includes information on performance testing for the Stealth Autoguide System, but lacks specific details on acceptance criteria and a study to prove the device meets all acceptance criteria in a comprehensive format. It also doesn't contain the requested information about training sets, expert ground truth development, MRMC studies, or standalone performance.

However, based on the provided text, I can extract the following information concerning the performance testing for the Stealth Autoguide System's accuracy:

Acceptance Criteria and Reported Device Performance for Stealth Autoguide™ System

Details of the Accuracy Study:

1. Sample size used for the test set and the data provenance: The document states that performance was determined using "overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms." Further specifics about the sample size (e.g., number of phantoms, number of measurement points per phantom) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The accuracy testing seems to be based on direct physical measurements against defined targets on phantoms rather than expert interpretation of images.

3. Adjudication method for the test set: This information is not provided. Given the nature of the accuracy testing (physical measurements), traditional adjudication methods for image interpretation would likely not apply.

4. 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: This information is not provided. The assessment described is a technical accuracy validation of the device's navigation and positioning capabilities, not a study involving human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Stealth Autoguide™ System" is described as a "robotic positioning and guidance system" and the accuracy validation focuses on its "performance in 3D positional accuracy" and "trajectory angle accuracy." This implies standalone technical performance testing of the system's ability to achieve planned trajectories, before a human surgeon uses it to guide instruments. The system is designed to "robotically position and orient instrument holders or tool guides," suggesting its core function is algorithm-driven positioning. However, the evaluation here focuses on the accuracy of the guidance provided, which would then be utilized by a surgeon.

6. The type of ground truth used: The ground truth for the accuracy study was established by defining "clinically relevant anatomical phantoms" and measuring the device's "performance in 3D positional accuracy" and "trajectory angle accuracy" against the known positions and trajectories on these phantoms. This is a phantom-based measurement ground truth.

7. The sample size for the training set: This information is not provided. The document describes an accuracy validation study, not the development or training of an AI algorithm.

8. How the ground truth for the training set was established: This information is not provided, as details about a training set are not included in the document.

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The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system.

The NavLock trackers are compatible with the MAZOR X Stealth™ Edition system. The NavLock Trackers are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock Trackers for optical navigation. The subject NavLock Trackers have posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera as a means of tracking the position of the attached surgical instrument.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system. The Robotic Reference Frame has posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera for tracking location during navigated procedures.

Unfortunately, the provided text does not contain the specific details required to answer all parts of your request. It's a 510(k) summary for a medical device (NavLock Trackers and Robotic Reference Frame) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed study report with all the acceptance criteria, sample sizes, and ground truth establishment methods for a performance study of an AI/algorithm-based device.

Here's an breakdown of what can and cannot be extracted from the text:

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

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

• Sample size for the test set: Not provided. The document states "Testing conducted" and refers to "the subject devices" satisfying requirements, but gives no indication of the number of devices, patients, or data points used in the Navigational Accuracy Analysis or Accelerated Life Functionality tests.
• Data provenance: Not provided. The document does not mention the origin of any data, whether prospective or retrospective, or country of origin.

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 / Not provided. These tests appear to be primarily engineering performance tests (navigational accuracy, durability) for hardware components, not a study evaluating an AI/algorithm's diagnostic or predictive performance against human experts. Therefore, there's no mention of experts establishing a "ground truth" for a test set in this context.

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

• Not applicable / Not provided. Similar to point 3, this type of adjudication is typically for clinical or diagnostic studies involving human interpretation or consensus, which is not described here.

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 does not describe an MRMC study. The devices (NavLock Trackers and Robotic Reference Frame) are accessories for a navigation system (MAZOR X Stealth™ Edition system) and are for hardware tracking, not AI-driven image analysis or decision support that would typically involve human readers.

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

• Not explicitly applicable in the AI sense. The devices themselves are hardware (trackers) that enable optical navigation. While the system (MAZOR X Stealth™ Edition) might involve algorithms, this document is about the physical accessories. The performance tests described (navigational accuracy, functionality) are "standalone" in the sense that they test the device's intrinsic mechanical/optical performance.

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

• For the "Navigational Accuracy Analysis," the ground truth would likely be established through precise metrology equipment or other highly accurate measurement systems, rather than expert consensus or pathology, as it's a measure of physical tracking accuracy. However, the specific method is not detailed.
• For "Accelerated Life Functionality," the ground truth is simply continued functionality and integrity of the device under stress, measured against engineering specifications.

8. The sample size for the training set:

• Not applicable / Not provided. Since this document describes hardware accessories for a navigation system and not an AI or algorithm-based device that undergoes machine learning training, there is no "training set."

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

• Not applicable / Not provided. (See point 8).

In summary:

This 510(k) summary provides a high-level overview of performance testing for medical device accessories. It confirms that the devices met "necessary navigational accuracy requirements" and maintained "functionality throughout its intended useful life" after reprocessing. However, it lacks the granular detail (specific numerical acceptance criteria, exact performance metrics, sample sizes, detailed ground truth methods, and expert involvement) that would be present in a comprehensive study report, especially one for an AI or algorithm-driven device. The focus here is on demonstrating equivalence to an existing predicate device rather than presenting a detailed clinical or AI algorithm validation study.

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