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OptiVu™ ROSA® MxR is indicated for displaying surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface. When accessing ROSA® MxR from a stereoscopic head mounted display (HMD), images viewed are for informational purposes only and are not intended for diagnostic use.

OptiVu™ ROSA® Mixed Reality (ROSA® MxR) is indicated for displaying surgical workflow images from the ROSA® RECON Platform and the corresponding ROSA® clinical applications intra-operatively during orthopedic surgeries. It is intended to provide an additional means of display where the ROSA® RECON Platform user interface is duplicated into a Mixed Reality see-through environment. OptiVu™ ROSA® MxR allows the ROSA® RECON Platform user interface and corresponding ROSA® clinical applications (e.g. ROSA® Knee, ROSA® Partial, or ROSA® Hip) to be streamed through a compatible head-mounted display (HMD) (e.g. HoloLens 2).

The subject device's main purpose is to place the duplicated virtual ROSA® user interface at a convenient location to provide the following functionalities:

• Mixed Reality visualization solution
• Register hand gestures as inputs such as to touch, move and resize views
• Wireless connectivity between a HMD (e.g. HoloLens 2) and the ROSA® RECON Platform

The OptiVu™ ROSA® MxR device is designed to display surgical workflow images from the ROSA® RECON platform in Mixed Reality. It includes functions for viewing the same surgical workflow steps and 2D visualizations as presented on the existing ROSA RECON platform user interface via a head-mounted display (HMD) like the HoloLens 2. It's important to note that images viewed through the HMD are for informational purposes only and are not intended for diagnostic use.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a typical tabular format. Instead, it describes general performance goals and verification activities. The overall acceptance criterion is demonstrating substantial equivalence to predicate devices without raising new questions of safety and effectiveness.

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

The document does not specify a separate "test set" in the context of a clinical study with patient data. The performance evaluations described are primarily non-clinical device performance testing, engineering analysis, software verification and validation, and usability engineering. Therefore, the concept of sample size for patient data or data provenance (country of origin, retrospective/prospective) is not directly applicable in the information provided.

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

As there is no mention of a clinical test set requiring expert-established ground truth related to patient data or diagnostic interpretations, this information is not provided. The device explicitly states that images viewed through the HMD are "for informational purposes only and are not intended for diagnostic use."

4. Adjudication Method for the Test Set

Given the absence of a clinical test set requiring expert interpretation of patient data, there is no mention of an adjudication method (e.g., 2+1, 3+1). The performance testing described focuses on the device's technical functionality and software integrity.

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 in the provided document. The device's indications for use emphasize displaying surgical workflow information rather than diagnostic interpretation or AI-driven decision support for human readers.

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

The document describes "Software Verification and Validation Testing" and "Device Performance Testing." While these are standalone tests of the algorithm's functional performance, they are not presented as a standalone clinical performance study in the sense of an algorithm making diagnostic or treatment decisions without human oversight. The device is an accessory for surgical workflow information display, not an autonomous diagnostic or therapeutic algorithm.

7. The Type of Ground Truth Used

For the software and device performance testing:

• Engineering specifications and design inputs served as the "ground truth" or reference for verification and validation activities. The tests aimed to ensure the device met these predefined requirements.
• Regulatory standards and guidance documents (e.g., FDA Guidance for Content Premarket Submissions for Software, IEC 62304) provided the "ground truth" for software quality and safety.

No "ground truth" in terms of expert consensus, pathology, or outcomes data for clinical decision-making is mentioned, consistent with its informational purpose.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning. The device appears to be primarily an interface and display tool, integrating with existing ROSA® RECON Platform software, rather than a system that learns from a large dataset.

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

As no training set (for machine learning) is discussed, the method for establishing its ground truth is not applicable or provided.

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-overative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

Modifications have been made to some of the applications to improve the overall workflow: however, the patient specific guides and bone models remain unchanged from the predicate. In addition, modifications have been made to the user interface of the planning application.

The provided text is a 510(k) summary for the Signature™ ONE System, a device for pre-operative planning and intra-operative guiding for shoulder replacement surgery. It discusses the device's indications for use, its similarity to a predicate device, and modifications made. However, the document does not contain the specific information requested regarding acceptance criteria, detailed study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance), or the ground truth establishment process.

The section "Summary of Performance Data (Nonclinical and/or Clinical)" only states:

• "Addition of a landmark to the Signature ONE Planner to display the location of the deepest glenoid point"
• "A feature is added to the Signature ONE Planner to display the medial/lateral translation between the backside on the implant and a reference landmark located on the most lateral point of the glenoid"
• "A feature is added to the Signature ONE Planner to display the percentage of contact between the selected implant and the glenoid surface"
• "All of the test steps passed successfully."

This is a very high-level summary and does not provide the detailed study information needed to answer your questions. This type of FDA clearance (510(k)) often relies on demonstrating substantial equivalence to a predicate device rather than presenting extensive, complex clinical trial data as might be seen for novel technologies or PMA (premarket approval) applications.

Therefore, I cannot provide the requested information from the given text. The document indicates that tests were performed and passed, but the specifics of those tests, the acceptance criteria, and how they proved the device meets those criteria are not detailed in this summary.

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Efficient Care 3D Planning is software indicated for assisting orthopedic surgeons in preoperative planning of knee orthopedic surgeries. The software allows for the overlaying of 3D/2D implant models and for the visualization of the radiological images and 3D reconstruction of bones, and includes tools for performing measurements on the images or 3D model of bones, and for selecting and positioning the implant model. Clinical judgments and experience are required to properly use the software.

Efficient Care 3D Planning is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex Gender, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Vanguard® CR, and Vanguard PS.

Efficient Care 3D Templating is software application that is intended to assist in the preoperative sizing of femoral and tibial implants. The software solution allows for the processing of multiple 2D X-rays to create 3D bone models that scales to patient bones and compensates for patient leg rotation in the X-rays images. The 3D bone models allow implant sizing to occur and output a template report, which includes overlays of prostheses, in respect to leg orientations on the X-ray images. Final implant sizing is based on intraoperative surgeon assessment.

The provided text describes the regulatory clearance of a medical device called "Efficient Care 3D Planning" but does not contain detailed information about a comprehensive study that establishes specific acceptance criteria and rigorously proves the device meets those criteria with detailed performance metrics.

However, based on the snippet provided under "Summary of Performance Data (Nonclinical and/or Clinical)", we can infer some information relevant to acceptance criteria and a study:

Inferred Acceptance Criteria and Reported Device Performance

Missing Information:

The provided text lacks specific details for most of the requested points. Below is a breakdown of what is not present in the document for a complete description of the study and acceptance criteria:

1. Sample sized used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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: Not indicated beyond the statement that "Clinical judgments and experience are required to properly use the software." This implies human involvement, but no MRMC study details are given.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Implant Predictability Tests" seem to describe an algorithm-only performance assessment against post-operative results. However, the exact methodology (standalone vs. assisted) isn't explicitly detailed.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the "Implant Predictability Tests," the ground truth was the "post-op implant size."
7. The sample size for the training set: Not specified.
8. How the ground truth for the training set was established: Not specified.

Additional Information from the text regarding device validation:

• Biocompatibility Testing: Conducted in accordance with ISO 10993. The device meets biocompatibility requirements.
• Software Verification & Validation Testing: Conducted and documented as recommended by FDA guidance. The software was considered a "moderate level of concern" meaning a failure could lead to "Minor Injury."

In summary, while the document mentions "Implant Predictability Tests" to confirm performance related to implant sizing accuracy, it does not provide the comprehensive study details, sample sizes, expert qualifications, or ground truth establishment methodologies that would typically be expected for a detailed description of device validation against acceptance criteria.

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The CAS PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively to plan the surgical placement of the components on the basis of provided patient radiological images with identifiable placement anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan.

The CAS PSI Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen CR, NexGen CR-Flex, Nexgen CR-Flex Gender, Nexgen LPS, Nexgen LPS-Flex, Nexgen LPS-Flex Gender, Persona CR, and Persona PS.

The patient specific guide components are intended for single-use only.

The CAS PSI Knee is an orthopedic instrument system indicated to assist in the positioning of knee replacement components. It involves surgical planning software used pre-operatively, and surgical instrument components that include patient specific guides to precisely align and position the implant components intra-operatively relative to each patient's anatomical features per the surgical plan. The surgical planning software allows the review of patient joint models determined from radiological images upon which the surgical placement of the implant components is adjusted per anatomical landmarks. The patient specific guides are fabricated per the patient models to fit each patient's anatomy with features that set the relative placement of the implant components per the surgical plan. The system is compatible with given implant systems per its indications for use.

The provided document describes the CAS PSI Knee System, an orthopedic instrument system designed to assist in the positioning of knee replacement components. It includes surgical planning software and patient-specific guides.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X mm" or "reproducibility must be within Y degrees"). Instead, it broadly describes the types of tests conducted and concludes with a statement of satisfactory performance for its intended use.

The overall conclusion is that "The information and data provided ... established that the CAS PSI Knee System is substantially equivalent to the predicates." This is the ultimate "acceptance" for 510(k) clearance, rather than meeting specific quantitative performance thresholds.

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

The document mentions "full use simulations tests using cadaver specimens or sawbones."

• Sample Size: The exact number of "cadaver specimens or sawbones" is not specified. It refers to generic plural forms.
• Data Provenance: The document does not specify the country of origin. The data is presented as prospective simulation tests conducted for validation.

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

• Number of Experts: "multiple surgeons." The exact number is not specified.
• Qualifications of Experts: They are described as "surgeons," implying medical doctors specializing in surgery, likely orthopedic surgeons given the context of knee replacement. No specific experience level (e.g., "10 years of experience") is provided.

4. Adjudication Method for the Test Set:

The document mentions "Full use simulations tests... were performed by multiple surgeons to verify and validate the overall system performance..." It states that "The results demonstrated satisfactory performance per the intended use." This suggests a consensus-based or qualitative evaluation by the surgeons, but no specific adjudication method (e.g., 2+1, 3+1, none) is detailed. The assessment of "satisfactory performance" is the reported outcome.

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

• No, an MRMC comparative effectiveness study was NOT explicitly stated or described in the provided text. The "full system validation tests" involved "multiple surgeons" but focused on verifying the system's performance and ergonomics, rather than comparing human reader performance with and without AI assistance or quantifying an effect size of improvement.

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

• Yes, standalone performance was assessed for the software components. The "Software Performance Tests" specifically focused on verifying "the reproducibility and accuracy of the software system algorithms. These included the accuracy and reproducibility of the software tools, the model meshing and segmentation methods, the assignment of surgical landmarks, the planning method, and the jig creation algorithms." This refers to the algorithm's performance without direct human intervention in the execution of the plan.

7. The Type of Ground Truth Used:

• For the "Software Performance Tests," the ground truth likely involved pre-defined anatomical landmarks and surgical plans against which the algorithm's output (meshing, segmentation, landmark assignment, planning, jig creation) was compared for accuracy and reproducibility.
• For the "Full System Validation Tests," the ground truth was effectively expert assessment/consensus ("satisfactory performance per the intended use") by multiple surgeons observing the system's usage and instrument ergonomics in simulation. It's an assessment of whether the system achieved the intended surgical outcome or allowed surgeons to achieve it.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set of the software. The software's capabilities are described (modeling patient anatomy from MRI scans, identifying landmarks, planning implant placement), but not the data used to develop or train these capabilities.

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

The document does not provide information on how the ground truth for the training set was established.

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CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.

CAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate locational reference instruments to bones in order to reference their location in Computer Assisted Surgery (CAS) systems.

This 510(k) summary describes a device, CAS Fixation Pins, which is substantially equivalent to a predicate device, the Navitrack System – Partial Hip Resurfacing Universal. The primary difference is the sterilization method. This submission does not include a study or performance data that would establish acceptance criteria for device performance related to a diagnostic or therapeutic function, nor does it involve an AI/ML algorithm.

Therefore, I cannot provide the information requested in the prompt based on the provided document because the device in question is a physical surgical instrument and the submission focuses on its equivalence in sterilization and packaging to a predicate device, not on AI-driven diagnostic or therapeutic performance.

The document states: "The proposed pin will be provided sterile using validated sterilization and packaging methods with an SAL of 10-9." This is the only "performance data" mentioned, pertaining to its sterility, not a functional or diagnostic performance. There is no mention of a "device performance" in terms of clinical outcomes or diagnostic accuracy.

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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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