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The NAVIO system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The NAVIO system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).

The NAVIO system is indicated for use with cemented implants only.

The NAVIO system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry of the surgical implant. The NAVIO system then aids the surgeon in executing the surgical plan by using a standard offthe-shelf surgical drill motor and bur (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.

The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The NAVIO system software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved in two ways:

• . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
• . Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.

Additionally, the surgeon can disable both controls and operate the NAVIO system handpiece as a standard navigated surgical drill. The surgeon must press on a footpedal to activate the surgical bur and enable cutting in all modes.

This FDA 510(k) summary for the NAVIO Surgical System (K191223) states that no human clinical testing was conducted to determine the safety and effectiveness of the updated device. Therefore, a study proving the device meets acceptance criteria as typically understood for clinical performance (e.g., accuracy against a medical outcome or expert ground truth) has not been provided in this document.

Instead, the submission relies on non-clinical (bench) testing to demonstrate performance and establish substantial equivalence to a predicate device (NAVIO Surgical System, K180271). The acceptance criteria and "reported device performance" would therefore relate to engineering specifications and functional verification rather than clinical outcomes.

Here's an attempt to answer your questions based only on the provided document, acknowledging the limitations due to the absence of clinical study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical performance targets or reported results in the traditional sense of a clinical study. It states that the device "meets the same accuracy specifications required for the predicate device." Without the predicate device's specific acceptance criteria documented here, we can only infer the type of performance evaluated.

The "study that proves the device meets the acceptance criteria" referred to in the document is a set of Non-Clinical Testing (Bench) activities, specifically:

• Software code reviews
• Bench testing
• Summative usability testing
• Labeling verification and validation testing

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

Given that no human clinical testing was conducted, there is no "test set" in the context of patient data for this submission. The "test set" would refer to the artifacts and software modules tested during the non-clinical verification and validation activities. The document does not specify the number of instruments, software versions, or test cases used in this non-clinical testing.

• Data Provenance: Not applicable in the context of patient data. The testing was likely conducted internally by the manufacturer.

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

This is not applicable as there was no test set derived from human patient data for which medical ground truth would be established by experts. Non-clinical testing typically relies on engineering specifications and gold-standard measurements or reference implementations to verify functionality and accuracy.

4. Adjudication Method for the Test Set

This is not applicable as there was no test set derived from human patient data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, as stated: "No human clinical testing was conducted to determine safety and effectiveness of the NAVIO system."

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

The device is a "computer-assisted orthopedic surgical navigation and surgical burring system," implying a human-in-the-loop system. The non-clinical testing focused on verifying the changes to this system. While specific algorithm-only performance metrics are not detailed, the "software code reviews" and "bench testing" would inherently evaluate the algorithms' functionality according to their design specifications, which is a form of standalone evaluation in an engineering context. However, it's not a standalone clinical performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be:

• Engineering Specifications: For functional performance and accuracy.
• Predicate Device Performance: The primary "ground truth" or benchmark is that the updated device "meets the same accuracy specifications required for the predicate device."
• Design Requirements: For software functionality and usability.
• Regulatory Requirements: For labeling verification.

8. The Sample Size for the Training Set

This is not applicable as the NAVIO Surgical System is a navigation and surgical burring system, not an AI/ML device that requires a "training set" for model development in the sense of supervised learning on patient data. The software updates mentioned (workflow, UI, infrastructure) refer to enhancements of the existing system's operational aspects.

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

This is not applicable as there is no mention of a "training set" in the context of AI/ML model development.

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The NAVIO system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The NAVIO system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).

The NAVIO system is indicated for use with cemented implants only.

The NAVIO system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperativelydefined bone landmarks and known geometry of the surgical implant. The NAVIO system then aids the surgeon in executing the surgical plan by using a standard off-theshelf surgical drill motor and bur (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.

The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The NAVIO system software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved in two ways:

• Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the NAVIO system retracts the bur inside the guard, disabling cutting.
• . Speed control regulates the signal going to the drill motor controller itself and will limit the speed of the drill if the target surface is approached. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features for femoral and tibial cut guides.

Additionally, the surgeon can disable both controls and operate the NAVIO system handpiece as a standard navigated surgical drill. The surgeon must press on a footpedal to activate the surgical bur and enable cutting in all modes.

Here's a breakdown of the acceptance criteria and the study information for the NAVIO™ Surgical System (NAVIO system) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it states that the device was verified against the "same accuracy specifications required for the predicate device." The reported performance is a qualitative statement of meeting these specifications.

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

• Sample Size: Not explicitly stated. The text mentions "simulated knees (sawbones)". The number of sawbones used is not provided.
• Data Provenance: The test data comes from bench testing using "simulated knees (sawbones)." This implies a controlled, non-clinical environment, not human data. The country of origin is not specified but is presumably where Blue Belt Technologies (or its successor, Smith & Nephew) conducts R&D/testing.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The testing was "performed by trained technical support personnel." Specific qualifications (e.g., years of experience, medical background) are not detailed beyond "trained technical support personnel."

4. Adjudication Method for the Test Set

Not applicable. The testing was described as "verification accuracy testing" using simulated knees performed by technical support personnel, not a process involving adjudication of expert opinions on a test set.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a surgical navigation and burring system (a robotic surgical assistant), not a diagnostic AI system typically evaluated with MRMC studies.

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

The study was primarily focused on verifying the accuracy and performance of the device's components (tracking camera, OS) in assisting the surgeon with predefined spatial boundaries and controlled burring. While the accuracy testing itself might assess the core algorithm's precision, the overall device is designed to be human-in-the-loop. The text indicates the surgeon uses the system: "The NAVIO system is intended to assist the surgeon..." and "...aids the surgeon in executing the surgical plan..." Therefore, a purely standalone clinical assessment would not be relevant for this type of device. The accuracy testing performed on sawbones could be considered a form of standalone performance assessment in a controlled environment as it evaluates the system's ability to accurately control the bur, but it's not a clinical standalone performance study.

7. The Type of Ground Truth Used

The ground truth for the "verification accuracy testing" was based on the "planned target surface" and "predefined boundaries generated during the planning process." In a bench setting with sawbones, the "ground truth" would be the precise, known dimensions and locations of the planned cuts or shapes defined by the system's software and verified against physical measurements or ideal models. It's not pathology, expert consensus on images, or outcomes data, but rather engineering-defined specifications for cutting accuracy.

8. The Sample Size for the Training Set

Not applicable. This submission concerns updates to an existing device (a new tracking camera and OS upgrade), and the study described is a verification and validation study for these changes, not the initial development or training of a machine learning model. The device itself is a computer-assisted surgical system, not explicitly described as employing a machine learning algorithm that requires a training set in the way a diagnostic AI would.

This document focuses on demonstrating that hardware/software updates did not negatively impact the already cleared device's performance, rather than on the initial establishment of performance for a novel AI algorithm.

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

Not applicable, as there was no mention of a training set for a machine learning model.

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The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement (UKR), patellofemoral arthroplasty (PFA), and total knee arthroplasty (TKA).

The Navio system is indicated for use with cemented implants only.

The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation, via a passive infrared tracking camera, to aid the surgeon in both establishing a bone surface model for the target surgery and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (Anspach eMax2 Plus System, cleared via K080802), which has been adapted using a tracking system.

The surgical bur is inserted into a handpiece, which allows the bur to move within the handpiece. The Navio system software controls the position of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard. This is referred to as Exposure Control mode.

An alternate mode of operation is the Speed Control mode. In this mode, the speed of the bur is controlled and the bur stops as the planned target surface is reached. In this mode of operation, the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes and fixation features.

The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for each data line entry, patient and procedure ID, implant ID, step in process, and error messages received by the user during the procedure. This data can be archived to a CD upon demand at the end of the procedure and is anonymized.

This document is a 510(k) summary for the Navio® system, specifically addressing an expanded indication for use to include total knee arthroplasty (TKA). Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and statistical proof of meeting those criteria is limited and framed within the context of establishing substantial equivalence for an expanded indication.

Here's an analysis of the provided text based on your request:

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

The document does not explicitly state quantitative acceptance criteria in a table. Instead, it relies on the concept of "substantial equivalence" and the demonstration that the expanded use for TKA does not raise new issues of safety or effectiveness compared to the predicate device.

The reported device performance, in this context, is that the system could successfully assist in TKA procedures in simulated environments.

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

• Sample Size: The document mentions "simulated-use testing included simulated knee (sawbones) and cadaver laboratory testing." It does not provide specific numbers for the cadaver lab or sawbones used. It does not mention any human clinical testing.
• Data Provenance: The testing was "Non-Clinical Testing (Bench)" and performed by "Blue Belt Technologies, Inc." This suggests it was likely internal testing. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it was bench/simulated testing.

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)

• The document states, "Users included surgeons, physician's assistants, and technical support personnel who were able to successfully use the Navio system..."
• It does not specify the number of experts, nor their detailed qualifications (e.g., years of experience, specific certifications). It only broadly categorizes them.
• The "ground truth" in this context would be the "specifications" of Blue Belt Technologies and the implant manufacturer, which these users were tasked to follow.

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

The document does not describe any formal adjudication method for the test set. The statement "Users... were able to successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications" implies that adherence to these specifications was the measure of success, but it does not detail how this "success" was adjudicated (e.g., by independent observers, a panel, etc.).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was conducted or mentioned in this document. The submission is a 510(k) for an expanded indication, relying heavily on non-clinical bench testing and similarity to a predicate device, not a comparative effectiveness study involving human readers/users in a clinical setting against a control group.

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

The Navio system is explicitly described as assisting the surgeon (human-in-the-loop). Therefore, a standalone (algorithm only) performance study would not be relevant and was not performed or mentioned. The system's function is to aid the surgeon, not to operate autonomously.

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

The ground truth for the non-clinical testing appears to be based on:

• Manufacturer's Specifications: The ability of testers to "successfully use the Navio system to place total knee implant systems per Blue Belt Technologies' and implant manufacturer's specifications."
• Expected Surgical Plan Execution: The system's ability to create a model, plan the surgery, and control bone removal as described in the device description.

This is not "expert consensus" in the sense of multiple independent experts agreeing on a diagnosis or measurement, nor is it pathology or outcomes data. It's more akin to validation against defined engineering and procedural standards for surgical preparation.

8. The sample size for the training set

The document does not mention any machine learning or AI training sets. The Navio system described uses "established technologies of navigation" and "pre-defined boundaries generated during the planning process" to control the surgical bur. It's a navigation and burring system, not explicitly described as an AI/ML device in this context. Therefore, a "training set" in the context of AI is not applicable here.

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

As no training set (in the AI/ML sense) is mentioned, this question is not applicable.

Ask a specific question about this device

The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.

The Navio system is indicated for use with cemented implants only.

The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the target surgery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System -K080802), which has been adapted using a tracking system. The surgical bur is located in a handpiece, which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached, the tip of the bur is fully retracted within the guard.

An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.

The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.

The provided text describes a 510(k) submission for a device modification to an existing surgical navigation system (Navio). The primary change is the incorporation of a new reflective tracking marker. Therefore, the majority of the testing presented is focused on demonstrating that this modification does not negatively impact the device's safety and effectiveness compared to the predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, noting limitations where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the device's performance (e.g., accuracy, precision). Instead, the studies aim to demonstrate that the modified device performs "as safe and effective as" the predicate device, K143668.

The nonclinical testing section indicates "bench verification testing," "clinical simulation (usability validation testing)," and "simulated-use testing in simulated knees (sawbones) and cadaver lab testing." The outcome of these tests is stated as "successfully use the Navio system," which implies an acceptable level of performance was achieved, but specific metrics are not provided.

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

• Test Set Sample Size:
  • For simulated-use testing, "simulated knees (sawbones)" and "cadaver lab testing" were used. The exact number of sawbones or cadavers is not specified.
  • For usability validation, "surgeons and technical support personnel" were involved, but the number of participants is not specified.
• Data Provenance: The studies are described as nonclinical bench and simulated-use testing. The origin of the sawbones or cadavers is not specified, but it is implied to be laboratory-controlled since no human clinical tests were conducted. These are retrospective in the sense that they are performed on non-living specimens or models, not on live patients in a prospective clinical trial.

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

• Number of Experts: The document states that "Users included surgeons and technical support personnel who were able to successfully use the Navio system" during clinical simulation. The exact number of surgeons or technical support personnel is not specified.
• Qualifications of Experts: The qualifications are generally stated as "surgeons" (implying orthopedic surgeons given the device's application) and "technical support personnel." Specific details like years of experience or board certifications are not provided.

4. Adjudication Method

The document does not describe a formal adjudication method for establishing ground truth or evaluating performance in the context of multiple expert opinions. The clinical simulation involved "users" (surgeons and technical support personnel) successfully using the system, suggesting a form of consensus or observation-based verification, but an explicit adjudication method (e.g., 2+1, 3+1) is not mentioned. Given the nature of a device modification and non-clinical testing, such a formal adjudication might not have been deemed necessary.

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

No. The document explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the Navio system." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

6. Standalone Performance Study

Yes. The nonclinical testing, including bench verification and simulated-use testing (sawbones, cadaver lab), represents standalone performance testing of the device with the new tracking markers. While human "users" were involved in the simulation, the focus was on the device's ability to function correctly and facilitate the surgical procedure with the modification, without a comparison to human performance without the device or without the AI. The goal was to confirm that the device performs as intended.

7. Type of Ground Truth Used

The ground truth for these nonclinical tests appears to be based on:

• Engineered/Simulated Ground Truth: For bench verification testing, the ground truth would be based on engineering specifications and known physical properties, ensuring the new marker functions according to design.
• Simulated Anatomical Ground Truth: For testing in "simulated knees (sawbones)" and "cadaver lab testing," the ground truth would be the known anatomical structures or the planned surgical resections as assessed by the participating surgeons or technical personnel. This is a form of expert-guided assessment of surgical accuracy and outcome in a simulated environment.

8. Sample Size for the Training Set

This 510(k) submission is for a device modification (a new tracking marker) to an existing system. The Navio system itself is a "computer-assisted orthopedic surgical navigation and surgical burring system" that uses "intraoperative data collection (image-free or non-CT data generation) to create a model of the patient's femur and tibia."

The document does not mention a training set in the context of an AI/machine learning algorithm for the new tracking marker. The new marker is a hardware component. The existing Navio system presumably relies on established algorithms and data collected previously for its navigation and planning functions, but details on that training set (if it exists for the core algorithms) are not part of this submission. This submission is focused on demonstrating that the new marker integrates seamlessly with the existing, validated system.

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

As noted above, no training set for a new AI/ML algorithm related to the tracking marker is described in this document. Therefore, information on how such a ground truth would be established for a training set is not applicable/provided in this context.

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The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty.

The Navio system is indicated for use with cemented implants only.

The Navio system is a computer-assisted orthopedic surgical navigation and surgical burring system. The system uses established technologies of navigation via a passive infrared tracking camera to aid the surgeon in establishing a bone surface model for the target surgery and to plan the surgical implant location based on predefined bone landmarks and known configuration of the surgical implant. The Navio system then aids the surgeon in executing the surgical plan by using a standard off-the-shelf surgical drill motor and bur (eMax 2 Plus System (K080802)), which has been adapted using a tracking system. The surgical bur is located in a handpiece which allows the bur to move within the handpiece. In the Navio system the software controls the position of the tip of the surgical bur relative to the end of a guard attached to the handpiece and prohibits the bur from cutting bone as it approaches the planned target surface. As the planned surface is reached the tip of the bur is fully retracted within the guard.

An alternate mode of operation is the speed control mode. In this mode the speed of the bur is controlled and the bur stops as the planned surface is reached. In this mode of operation the bur does not retract into the guard. This mode of operation is useful in shaping surfaces of the condyle as well as placing post holes.

The Navio computer system maintains a log of the patient data and procedure data. Each entry is date and time stamped. Data log entries include date and time stamp for data line entry, patient and procedure ID, implant ID, step in process, and error messages. This data can be archived to a CD upon demand at the end of the procedure.

The provided text describes the Navio™ system, an orthopedic stereotaxic instrument for computer-assisted knee procedures. The submission is a Traditional 510(k) for expanded indications to include patellofemoral arthroplasty (PFA).

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of specific performance metrics or thresholds (e.g., accuracy, precision) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing.

The "reported device performance" is primarily qualitative, stating that the device is "as safe and effective and performs as well as the Blue Belt Technologies NavioPFS™ (K121936) or the MAKO Surgical Corp. Tactile Guidance System v2.0 (K081867)."

Therefore, a table of acceptance criteria and reported device performance as explicitly stated in quantified terms is not present in the provided document. The acceptance was based on the successful completion of nonclinical tests and a demonstration of equivalency in technological characteristics and workflow to predicate devices.

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

• Test Set Sample Size: Not specified quantitatively. The "clinical simulation (usability testing)" and "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing" do not provide specific numbers for the test set or the number of simulated knees/cadavers used.
• Data Provenance: The testing was non-clinical. The document does not mention the country of origin for the cadaver lab testing or if any specific demographic data was considered for the sawbones. It's retrospective in the sense that no new human clinical trials were conducted to generate prospective clinical data for this specific submission.

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

• Number of Experts: Not explicitly stated. The document mentions "Users included surgeons, physician's assistants, and technical support personnel" for usability testing. It does not quantify how many of each were involved or what their specific role was in establishing "ground truth," which implies a reference standard rather than just users.
• Qualifications of Experts: General qualifications are provided: "surgeons, physician's assistants, and technical support personnel." Specific experience levels (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Since the testing was non-clinical (simulated-use, cadaver, bench) and primarily focused on verifying design, software, and usability, a formal adjudication method typically seen in clinical trials with multiple human readers for diagnostic accuracy is not described. The document states that users "were able to successfully use the Navio system and place implants per Blue Belt Technologies' specifications," implying an internal assessment rather than an adjudicated consensus.

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

No. The document explicitly states: "No human clinical tests were conducted to determine safety and effectiveness of the Navio system." Therefore, no MRMC comparative effectiveness study was performed.

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

The device itself is an "Orthopedic Sterotaxic Instrument" designed to "assist the surgeon" and is described as a "computer-assisted orthopedic surgical navigation and surgical burring system." Its function inherently involves human interaction, as it controls a surgical bur based on a plan developed by the surgeon with the system's aid. Therefore, a standalone (algorithm only without human-in-the-loop performance) study would not be applicable for this type of device, as its core function is to augment a human surgeon's actions. The non-clinical testing focused on the system's performance in aiding a user.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" implicitly refers to:

• Blue Belt Technologies' specifications: Implants were placed "per Blue Belt Technologies' specifications."
• Planned target surface: The system controls the bur relative to a "planned target surface."
• Bone Model Refinement: The system aids in creating a model, and the burring is controlled based on this model and planned surfaces.

This suggests that the ground truth was primarily based on the predefined surgical plan and specifications established by the device's design and intended surgical outcomes, potentially verified against physical measurements in simulated and cadaveric models. It does not refer to external pathology reports or long-term patient outcomes for this type of non-clinical evaluation.

8. The Sample Size for the Training Set

Not applicable/Not specified. This device is a surgical navigation and burring system, not an AI/ML algorithm that requires a "training set" in the traditional sense of machine learning for image analysis or diagnosis. The software's functionality is based on established engineering principles for navigation and robotic control, not learning from a dataset of cases.

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

Not applicable. As noted above, there is no "training set" in the context of supervised machine learning for this device. The software logic and control parameters are designed and verified against engineering specifications and real-world biomechanical principles, not trained on a dataset of ground-truthed "examples."

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