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The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

The Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of total knee replacement components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the components.

The provided text is a 510(k) summary for the Navitrack® System - OS Knee Universal, a computer-assisted surgical navigation system for Total Knee Replacement. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials for novel devices.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not explicitly available in this document. The document describes non-clinical tests and validation on cadavers, but does not provide specific quantitative results against pre-defined acceptance criteria.

Below is an attempt to address the request based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "simulated use on cadavers," implying a cadaveric study, but numbers are not provided.
• Data Provenance: The tests were conducted internally by the manufacturer ("Non-clinical tests were performed to assess...") as part of a 510(k) submission. The exact country of origin for the cadavers or test facility is not specified but the applicant is based in Montreal, Quebec, Canada. The testing was prospective for the device modifications.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly mentioned. Given the nature of cadaveric testing for a surgical navigation system, ground truth would likely be established through direct measurement or observation during the simulated surgical procedures, potentially involving qualified surgical personnel, but the specific method is not detailed.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing for substantial equivalence, not a comparative study with human readers or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance: The performance data described is a form of standalone performance in a simulated environment (cadaveric testing) to assess the device's functionality. The focus is on the device's ability to track and display anatomical information and instrument positions accurately, rather than an evaluation of an algorithm's diagnostic output. Specific metrics of standalone accuracy (e.g., angular deviation, translational error) are not quantified in this summary.

7. Type of Ground Truth Used

• Ground Truth Type: Based on "simulated use on cadavers" and "Non-clinical tests," the ground truth was likely established through direct physical measurement and observation within the cadaveric environment of anatomical landmarks and instrument positions, to verify the system's accuracy and functionality. It would be a technical/engineering ground truth related to mechanical and tracking accuracy.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable in the traditional sense of machine learning training data. This device is a stereotaxic instrument for surgical guidance, not a diagnostic AI system that learns from a large dataset. The "training" in this context refers to the development and refinement of the software and hardware, which occurs iteratively rather than through a distinct "training set" of data.

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

• Ground Truth for Training Set Establishment: Not applicable as there isn't a "training set" in the machine learning sense. The underlying physics and algorithms for tracking and navigation are based on established principles, and their accuracy would be continuously validated during the device's development cycle against known physical properties and measurements.

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The Navitrack® System - Partial Hip Resurfacing Universal is indicated for use as a stereotaxic instrument to assist in the positioning of partial hip resurfacing components.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip femoral resurfacing components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

The Navitrack® System – Partial Hip Resurfacing Universal system consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of partial hip resurfacing components.

Tracking devices are incorporated onto given surgical instruments and onto fixation bases attached to the femur by which the system tracks their relative locations and displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components.

The instruments that are tracked include a drill guide to help position the implant's system guide wire or pin that sets the central axis for the implants. The femoral reference geometries relative to which the guide wire location is to be positioned include representations of the femoral head and neck surfaces as rendered by clouds of points that are digitized by the user using the system.

In addition, the system also allows for specific implant models as obtained from the implant manufacturers to also be included in the system. In this mode, the system also displays the implant models relative to the bony geometries corresponding to the placement.

The provided text describes a 510(k) premarket notification for the Navitrack® System – Partial Hip Resurfacing Universal. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance data from a specific study demonstrating acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided document.

However, I can extract the available information and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document only mentions "Non-clinical tests" without detailing specific test sets, cases, or the number of components tested.
• Data Provenance: Not specified, but given the non-clinical nature of the tests, it would likely be laboratory or bench testing data rather than patient data.

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

• Not applicable/Not specified. Since the tests were "non-clinical," traditional ground truth established by medical experts for a diagnostic or interventional outcome is not described. The "accuracy and performance" would likely be compared against a known physical reference or measurement in a laboratory setting.

4. Adjudication Method for the Test Set

• Not applicable/Not specified, as no expert review or adjudication process for a test set is described.

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

• No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on establishing substantial equivalence through non-clinical accuracy and performance tests.

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

• The device is a "computer controlled image-guidance system equipped with a three-dimensional tracking sub-system" intended to "assist the surgeon." The description of the device's function implies human-in-the-loop operation, as it "displays back to the user corresponding positional information intra-operatively to initially plan and then guide the positioning of the components." While "non-clinical tests" were done, it's not specified if these were purely standalone algorithmic evaluations or if they simulated the full human-in-the-loop workflow. However, the phrasing "accuracy and performance of the system was adequate for its intended use" suggests evaluating the device in its intended assistive role.

7. The Type of Ground Truth Used

• The document does not explicitly state the type of ground truth used. For "non-clinical tests" assessing "accuracy and performance" of a surgical navigation system, the ground truth would typically be established by high-precision measurement tools (e.g., CMM, optical trackers, or precise mechanical fixtures) against known geometric configurations or reference points in a laboratory setting. This would serve as the "true" position or alignment against which the system's measurements are compared.

8. The Sample Size for the Training Set

• Not applicable/Not specified. The document describes a "stereotaxic instrument" and "image-guidance system" which implies a rule-based or model-based system for tracking and display, rather than a machine learning model that requires a "training set" in the conventional sense. The "models" mentioned ("specific implant models... to also be included in the system") refer to CAD models of implants, not training data for an AI algorithm.

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

• Not applicable/Not specified, as there is no mention of a training set for a machine learning model. The "ground truth" for the system's underlying operations (e.g., tracking accuracy, display fidelity) would be established by engineering specifications and metrology.

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The Navitrack® System -- OS Unicondylar Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of unicondylar knee replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

The Navitrack System - OS Unicondylar Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of unicondylar knee replacement components.

Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the components.

The Navitrack® System – OS Unicondylar Knee Universal is a stereotaxic instrument designed to assist in the positioning of unicondylar knee replacement components intra-operatively. It uses a computer-controlled image-guidance system with a 3D tracking sub-system to determine reference alignment axes and precisely position alignment instruments.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria. Instead, it makes a general claim regarding performance compared to a predicate device.

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

The document states "Non-clinical tests were performed" to assess accuracy and performance. However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as "assisting the surgeon," implying human involvement, but no formal comparative study with human readers is detailed.

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

The document describes the device as providing "image guidance assistance" to the surgeon, indicating a human-in-the-loop system. It does not state whether a standalone (algorithm-only) performance evaluation was conducted.

7. The Type of Ground Truth Used

The document describes the performance assessment as "non-clinical tests" to verify accuracy and performance. Given the nature of a surgical navigation system, the "ground truth" for accuracy would likely involve:

• Physical measurements/phantoms: Using precise physical models or phantoms where the true anatomical landmarks and alignment axes are known and can be independently verified.
• Engineering specifications/tolerances: Comparing the device's measurements and guidance to pre-defined engineering tolerances for surgical accuracy.

However, the document does not explicitly state the specific type of ground truth used.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. Since this is a navigation system that digitizes anatomical landmarks and guides instrument placement, it's possible that a "training set" in the traditional machine learning sense might not be applicable or explicitly mentioned as it would be for an AI-diagnostic device. The system's core functionality relies on established anatomical referencing and geometric calculations, rather than a learning algorithm trained on a dataset of cases.

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

As no training set is mentioned (see point 8), the document does not describe how ground truth for a training set was established.

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The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Identically as in the predicates, the Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicates are to incorporate a new set of instruments with universal implant instrument interface features along with corresponding software changes such that the application can be compatible to track a variety of TKR implant lines.

The provided text describes the Navitrack® System - OS Knee Universal and its substantial equivalence to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria.

The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicates." However, it does not provide the results of these tests, the specific metrics used, or the thresholds for "adequate" performance.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

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

• Sample size for test set: Not specified.
• Data provenance: Not specified.

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 as the document does not describe a clinical study with expert ground truth establishment. The "non-clinical tests" likely refer to bench testing or simulation.

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

• No MRMC study was described. The device is a navigation system, not an AI diagnostic tool for human readers.

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

• The document mentions "non-clinical tests" to verify accuracy and performance "adequate for its intended use and not reduced in comparison to the predicates." This implies standalone testing of the system's accuracy, but no details of the test or results are provided.

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

• Not specified. For non-clinical tests of a navigation system, ground truth would likely involve highly precise measurement instruments (e.g., coordinate measuring machines, optical tracking systems with known accuracy) to establish the true position/orientation of anatomical landmarks or instruments.

8. The sample size for the training set

• The document does not describe a machine learning model that would require a "training set" in the typical sense. This device is a computer-assisted surgical navigation system based on established principles of optical tracking and anatomical landmark registration, not a deep learning model requiring vast training data.

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

• Not applicable.

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The Navitrack® System -- S&N Image Free Knee is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intra-operatively.

It is a computer controlled image-guidance system equipped with a threedimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.

Identically as in the predicate, the Navitrack® System - S&N Image Free Knee device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Knee Replacement (TKR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intraoperatively by identifying the key anatomical references that are used clinically to align and position the TKR components. The instruments are schematically represented. The main modifications to the predicate are to incorporate a new set of instruments to be tracked corresponding to assisting the placement of two new TKR implant lines.

The provided text is a 510(k) summary for the Navitrack® System - S&N Image Free Knee. While it describes the device and its intended use, it does not contain the detailed information required to fill out the table of acceptance criteria, device performance, and study specifics.

The summary explicitly states:
"Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. These included tests and analyses to verify that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison to the predicate."

This statement indicates that performance data and tests were conducted, but the results of these tests, specific acceptance criteria, sample sizes, expert qualifications, and other requested details are not included in this document. The document primarily focuses on establishing substantial equivalence to a predicate device based on unchanged fundamental technology, intended use, indications, and operating principles, with modifications mainly for new instrument integration and software enhancements.

Therefore, I cannot generate the requested table and answer the specific questions based solely on the provided text. The document is a summary for regulatory submission, not a detailed study report.

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The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

Identically as in the predicate, the Navitrack TM System - Total Hip Replacement CT-Free device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented. The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.

The provided FDA 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free does not contain explicit acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.

The document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the modifications to the predicate device (adding femoral tracking capabilities) do not raise new safety or efficacy issues and that the fundamental technology remains the same.

Here's an breakdown of the information that can be extracted and the information that is not present based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated. The document indicates "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system in depicting the positioning of the femoral THR component was adequate for its intended use." This is a general statement, not a quantifiable criterion.
• Reported Device Performance: Not explicitly provided with numerical values. The conclusion states the device is "substantially equivalent" and implies adequate accuracy and performance, but no specific metrics (e.g., accuracy, precision, sensitivity, specificity) are reported.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

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

• Not mentioned. The device's function involves a surgeon (user) identifying and digitizing key anatomical landmarks. Therefore, the "ground truth" during operation relies on the surgeon's input, but for formal testing, details about expert involvement are absent.

4. Adjudication Method for the Test Set:

• Not mentioned.

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

• No MRMC study is mentioned. The document is for a computer-assisted surgical navigation system, not an imaging diagnostic device typically requiring MRMC studies for reader performance.

6. Standalone (Algorithm Only) Performance Study:

• The document describes "non-clinical tests" to verify accuracy and performance. While this implies a standalone assessment of the system's ability to track and display positions, no specific quantitative results or details of such a study are provided.

7. Type of Ground Truth Used:

• The system itself determines alignment axes based on "user-identified anatomical landmarks." For non-clinical testing, the "ground truth" would likely involve highly precise measurements using phantoms or cadaveric models, but this is not detailed. The document does not specify the ground truth used for performance assessment.

8. Sample Size for the Training Set:

• Not mentioned. Surgical navigation systems like this typically rely on pre-programmed anatomical models and algorithms rather than a "training set" in the machine learning sense for image recognition. The "training" would be in the form of algorithm development and refinement, not typically dataset-driven.

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

• Not mentioned, as the concept of a "training set" in the machine learning context isn't directly applicable or described here.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence based on technological comparisons and a general statement about non-clinical testing for accuracy and performance for "intended use." It lacks the detailed quantitative performance data, specific acceptance criteria, and study methodologies typically found in submissions for AI/ML-driven diagnostic devices or those requiring extensive clinical validation with detailed ground truth establishment. The nature of this device (a surgical navigation system) means its "performance" is often evaluated differently than a diagnostic imaging device.

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The Navitrack™ System - Total Hip Replacement CT-Free is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

Identically as in the predicate, the Navitrack™ System – Total Hip Replacement CT-Free device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intraoperatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the kev anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented. The modifications to the predicate are to additionally track the femur and femoral instrumentation similarly as is done for the pelvis, in order to also assist in the placement of the THR components for the femur.

The Navitrack™ System – Total Hip Replacement CT-Free is a surgical navigation system that assists in the placement of Total Hip Replacement (THR) components.

Here's an analysis of its performance data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states that "Non-clinical tests were performed." It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). Given the nature of a non-clinical test for a surgical navigation system, it likely involved bench testing or cadaveric studies, rather than patient data.

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

The document does not mention the use of experts to establish a ground truth for the test set. The "non-clinical tests" likely focused on technical performance and accuracy measurements rather than expert clinical assessment of outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-based ground truth establishment is described.

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

No mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The document focuses on the technical performance and substantial equivalence to a predicate, not on a direct comparison of human reader performance with and without AI assistance.

6. Standalone Performance:

Yes, a standalone (algorithm only without human-in-the-loop performance) study was inferred from the "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system in depicting the positioning of the femoral THR component was adequate for its intended use." This indicates the system's ability to accurately depict component positioning, which is an intrinsic function of the algorithm.

7. Type of Ground Truth Used:

The type of ground truth used for the non-clinical tests is not explicitly stated but can be inferred as technical or metrological ground truth. For a navigation system, this would typically involve:

• Precise physical measurements: Using highly accurate measurement tools (e.g., CMM, optical trackers, calibrated jigs) to determine the true position and orientation of components in a controlled environment.
• Geometric models: Comparing the system's output to known, precisely defined geometric models of the pelvic and femoral anatomy and the THR components.

It is not expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies or diagnostic devices.

8. Sample Size for the Training Set:

The document does not provide any information about a training set size. This device describes a "software-driven workstation" and an "optical tracking system" that uses "user-identified anatomical landmarks" to determine alignment axes. This suggests a rule-based or model-based system, rather than a machine learning model that would typically require a distinct training set. The "software was correspondingly modified to handle the added capabilities" rather than "retrained."

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

Not applicable, as there is no mention of a traditional machine learning training set or associated ground truth establishment process. The "ground truth" for the system's functionality is likely embedded in the engineering design, calibration, and pre-defined algorithms for geometric calculations based on digitized landmarks.

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The Navitrack™ System - Total Hip Replacement CT-Free Cup is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.

The Navitrack™ System - Total Hip Replacement CT-Free Cup device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.

The provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free Cup, focusing on demonstrating substantial equivalence to a predicate device.

Specifically, the "Performance Data" section states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate as compared to the predicate." This indicates that some form of comparison was done, but no specific acceptance criteria, study design, or performance metrics are detailed.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study to prove they are met. The information is simply not present in the provided text.

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The Navitrack™ System - FluoroSpine is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopaedic surgery, such as operations performed within spinal structures.

The Navitrack™ System enables the surgeon to review radiology images from different modalities in 2D and 3D display. This system also enables the surgeon to virtually manipulate bone structures as reconstructed from these modalities in order to perform preoperative planning.

The Navitrack "10 System - FluoroSpine device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of spine reconstruction components relative to the vertebrae. Tracking devices are incorporated with given surgical instruments, as well as on to bases that attach to the vertebrae, such to allow the ability to track and display to the user their respective positions intra-operatively. The vertebrae are displayed to the user as based on a fluoroscopic image obtained at the beginning of the procedure. Given instrument and implant components that need to be positioned are schematically represented superimposed on the vertebrae image to depict their relative locations.

The provided text describes the Navitrack™ System - FluoroSpine, a stereotaxic instrument for orthopedic surgery, and its 510(k) submission (K031156). However, the document does not explicitly state specific acceptance criteria or report detailed performance metrics with numerical values in a table format.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Navitrack System™ - Optical Option). The performance data section vaguely states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate as compared to the predicate." This indicates that the performance criteria were implicitly tied to matching or not degrading from the predicate's performance.

Given the information provided, here's an attempt to outline the requested details, with significant parts indicating where information is not available in the given text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document. The text only mentions "Non-clinical tests were performed." It does not detail specific cases, images, or scenarios used in testing.
• Data Provenance: Not specified. There is no mention of country of origin, or whether the data was retrospective or prospective. Given the non-clinical nature mentioned, it's likely referring to bench testing or simulations rather than patient data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  The document focuses on "non-clinical tests" and comparison to a predicate, not on a study involving expert-established ground truth for a test set of clinical images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified/Not applicable. As no expert review or ground truth establishment based on clinical data is detailed, an adjudication method is not described.

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

• MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The evaluation focused on the device's functional equivalence to a predicate.
• Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable as no MRMC study was reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: The document describes "non-clinical tests" to verify "accuracy and performance of the system." While not explicitly called a "standalone study," the nature of these tests, comparing the system's output to that of the predicate, suggests an evaluation of the algorithm/system's inherent performance rather than human-in-the-loop performance. However, the exact methodology and metrics are not detailed.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document implies that the ground truth for "accuracy and performance" verification was likely established by the performance of the predicate device (Navitrack System™ - Optical Option) or by known engineering specifications/measurements for the new system's components and overall function during non-clinical testing. It is not based on expert consensus, pathology, or outcomes data as would be typical for image analysis AI.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The Navitrack™ System - FluoroSpine is described as a software-driven workstation that assists surgeons by superimposing schematic representations on fluoroscopic images. It is not an AI/ML algorithm that learns from a training set in the typical sense (e.g., for image classification or segmentation). Its functionality involves processing real-time fluoroscopic images and tracking instruments. The document describes "changes to the software" and new accessories, implying engineering and software development, but not a machine learning training phase with a specific dataset.

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

• Ground Truth for Training Set: Not applicable/Not specified. As the device is not presented as an AI/ML system trained on a dataset requiring labeled ground truth in the traditional sense, this information is not relevant or provided in the context of this 510(k) summary. The "ground truth" for its development would be based on engineering principles, physics of imaging, and surgical requirements for accuracy and usability.

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The Navitrack™ System – Total Hip Replacement is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system that integrates a threedimensional tracking sub-system and image-processing software. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images.

The Navitrack™ System - Total Hip Replacement device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as onto fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The bones of interest are displayed to the user as three-dimensional (3D) surface models, while the instruments are schematically represented. Models of the implant are also represented in order to visualize their placement using the instruments. The 3D models of the pelvis are reconstructed pre-operatively from given CT-images using image processing tools provided with the software. The software also provides planning features by allowing the user to determine pre-operatively an ideal location for the implants as based on the models.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Navitrack™ System - Total Hip Replacement:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended." However, it does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly states that the system's "accuracy and performance...was adequate."

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

The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying it was likely conducted in a lab environment rather than with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the "non-clinical tests" described, which likely involved technical verification rather than medical interpretation.

4. Adjudication Method for the Test Set:

Since there's no mention of experts or a test set requiring interpretation, there's no information on any adjudication method.

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

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on how human readers perform with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was done. The document states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate to perform as intended." This indicates that the device, as an "algorithm only without human-in-the loop performance" component, was tested.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of the device (a stereotaxic instrument for hip replacement component positioning) and the "non-clinical tests," the ground truth was likely based on engineering specifications, physical measurements, and known geometric truths obtained in a controlled laboratory setting (e.g., using phantoms or precise physical models). It was not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. The "non-clinical tests" seem to refer to verification and validation of the completed system, not a machine learning model that would require a separate training set. The device uses "models of the pelvis... reconstructed pre-operatively from given CT-images using image processing tools provided with the software," implying rule-based or traditional image processing rather than data-driven machine learning that typically requires a training set.

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

Since a training set is not explicitly mentioned as being used for a machine learning model, there's no information on how its ground truth would have been established. The device relies on "image processing tools" and 3D surface model reconstruction from CT images, suggesting a deterministic approach rather than one requiring labeled training data for an AI model.

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