Search Results

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.

Ask a specific question about this device

The ClearLLab 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios EX flow cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukemia, non-Hodgkin lymphoma, myeloma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ACD) or Heparin), bone marrow (collected in K2EDTA, ACD or Heparin) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.

These reagents provide multiparameter, qualitative results for the surface antigens listed below:

• ClearLLab 10C B Cell Tube: Kappa, Lambda, CD10, CD5, CD200, CD34, CD38, CD20, CD19, CD45
• ClearLLab 10C T Cell Tube: TCRy8, CD4, CD2, CD56, CD5, CD34, CD3, CD8, CD7, CD45
• ClearLLab 10C M1 Cell Tube: CD16, CD7, CD10, CD13, CD64, CD34, CD14, HLA-DR, CD11b, CD45
• ClearLLab 10C M2 Cell Tube: CD15, CD123, CD117, CD13, CD34, CD38, HLA-DR, CD19, CD45

The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to ten fluorescent detection channels using three lasers (488 nm, and 405 mm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The new ClearLLab 10C reagent system is comprised of various components and is described below. Figures 2 and 3 illustrate the anticipated workflow from instrument setup through data analysis with a breakout of the standardization and Quality Control sequence for the new reagent system. As the figures show, the process is in-line with standard flow cytometry protocol.

• Four ClearLLab 10C Panels [B, T, M1 and M2]
• Navios and Navios EX flow cytometers [3 laser/10 color configurations]
• ClearLLab Compensation Kit
• ClearLLab Compensation Beads
• ClearLLab Control Cells, normal and abnormal
• Kaluza C data analysis software
• Flow-Check Pro Fluorospheres
• Flow-Set Pro Fluorospheres
• IOTest 3 Fixative Solution
• IOTest 3 Lysing Solution

The ClearLLab 10C reagent system is run on Beckman Coulter's Navios or Navios EX flow cytometer (3 Laser/10 Color configurations). It requires off-line manual sample processing and use of the accompanying lysing reagent. As part of the ClearLLab 10C reagent system, to allow proper utilization of this application, the indications for the Navios and Navios EX flow cytometers include all ten fluorescent detection channels and three laser configurations (blue, red and violet).

LMD data analysis is performed manually using the Kaluza C Analysis Software. This Analysis Software package is supplied separately from the Navios EX system softwares and must be installed on an independent computer workstation for off-line analysis of listmode files generated on the flow cytometer with the associated reagents and cytometer system software package, including Control Cell OC data and sample data analysis. The Navios and Navios EX analysis software are NOT be recommended for use with this application (Note that QC data from Flow-Set Pro, Flow-Check Pro, and Compensation products will continue to be analyzed using the on-board instrument software).

Kaluza C Software is a software tool designed to work with *.Imd files generated from flow cytometers.

Preset Kaluza C analysis templates for the ClearLLab 10c reagent system are provided.

The provided text describes the ClearLLab 10C Panels and associated Navios and Navios EX Flow Cytometers. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a single table delineating acceptance criteria and reported device performance for each metric. Instead, it lists various studies performed, their objectives, and their results, which implicitly demonstrate an acceptance of performance. The "Testing Results" column in the tables effectively serves as the "Reported Device Performance," and the objective of each study implies the acceptance criteria (i.e., demonstrating stability, linearity, equivalency, specificity, etc.).

Below is a summary derived from the "Testing Results" section (pages 18-19):

ClearLLab 10C Panels, Navios and Navios EX Flow Cytometers Acceptance Criteria and Performance Summary

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size for all studies. However, for the "Precision - Multi-Site with Clinical Specimens" and "Precision - Operator and Instrument Variability" studies, typical clinical specimens (both normal and abnormal) were used. The specific number of specimens for each study is not explicitly stated in the provided text.
• Data Provenance: The document does not explicitly state the country of origin. The "Clinical Accuracy" study mentions "the site's clinical diagnosis," indicating that the data likely came from clinical sites where the study was conducted. The studies appear to be prospective in nature, as they involve actively verifying performance, stability, and equivalency.

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

• For the "Clinical Accuracy" study, the comparison was made against "the site's clinical diagnosis of malignant or non-malignant outcome from the current standard of care." The interpretation of results for the device itself is stated to "be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings" (page 2). This indicates that pathologists or equivalent professionals establish the ground truth for clinical cases. The number of such experts is not specified.

4. Adjudication Method for the Test Set

• The document implies that the ground truth for "Clinical Accuracy" is established by "the site's clinical diagnosis...from the current standard of care" and confirmed by a "pathologist or equivalent professional." However, it does not explicitly describe an adjudication method (such as 2+1, 3+1, or none) for resolving discrepancies among multiple expert opinions on a specific case.

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

• The provided text does not describe a multi-reader, multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance (which is not relevant for this device as it's a diagnostic reagent and flow cytometer system, not an AI interpretative software for human review).

6. Standalone Performance Study

• The studies described, particularly those evaluating laser performance, instrument linearity, carryover, and reagent characteristics, are inherently standalone (algorithm/system only) performance studies. The system is evaluated on its ability to accurately detect and characterize cell populations. The "Clinical Accuracy" study also assesses the device's ability to identify abnormal populations against clinical outcomes, which is a standalone evaluation of its diagnostic capability.

7. Type of Ground Truth Used

• For various analytical studies (e.g., linearity, carryover, precision), the ground truth is established by reference standards, control materials, and comparative methods (e.g., predicate devices).
• For the "Clinical Accuracy" study, the ground truth is based on clinical diagnosis of malignant or non-malignant outcome from the current standard of care, confirmed by pathologist or equivalent professional consensus in conjunction with other clinical and laboratory findings.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" as the devices described are diagnostic reagents and flow cytometers, not AI models that require specific training data in the context of machine learning. The studies listed are for performance verification and validation.

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

• As there is no explicit mention of a "training set" in the context of an AI/machine learning model, this information is not applicable and is not provided in the document.

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 (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.

Ask a specific question about this device

The Navios EX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to four fluorescent detection channels using a blue (488 nm) laser and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

The Navios EX tetra Software is intended for use as an in vitro diagnostic device for immunophenotyping with CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5 and CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 monoclonal antibody reagents on the Navios EX Flow Cytometer.

It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD3+CD8+, CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood. Absolute counts may be determined by the Navios EX Flow Cytometers using Flow-Count Fluorospheres (Single Platform Technology (SPT) Method) or separate hematology results (Dual Platform Method). It is indicated for use in the immunologic assessment of patients having or suspected of having immune deficiency.

The Navios EX Flow Cytometry System consists of:

• Navios EX Flow Cytometer
• Navios EX tetra Software
• Navios EX Software off-line analysis tool
• CYTO-STAT tetraCHROME reagents
• Flow-Set Pro Fluorospheres
• Flow-Check Pro Fluorospheres
• Flow-Count Fluorospheres
• Immuno-Trol Cells
• Immuno-Trol Low Cells
• COULTER IMMUNOPREP Reagent System
• QuickCOMP 2 and QuickCOMP 4 Kits
• CYTO-COMP Cell Kit
• ISOFLOW Sheath Fluid
• FlowClean Cleaning Reagent
• TQ-Prep Workstation (accessory for sample preparation)
• PrepPlus 2 Workstation (accessory for sample preparation)

The Navios EX Flow Cytometry System is the next generation product in the Navios Flow Cytometry family. With the Navios EX flow cytometer and associated software, the following modifications have been introduced:

• Replacement of optical assemblies and flow cell
• Replacement of the existing 488nm laser with a comparable 488nm laser
• Replacement of the band-pass filter (FL3) used for ECD dye
• Replacement of the Forward Scatter mask with a new mask configuration
• Replacement of the existing fixed aspiration probe with an adjustable one. This probe is adjusted by the service engineer only to account for the sample tube employed at the customer's laboratory.
• Change to the optics module temperature management hardware
• Minor change to the sheath pressure
• Minor changes to the Navios EX tetra algorithm

Here's a breakdown of the acceptance criteria and study information for the Navios EX Flow Cytometry System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document generally states "meets performance requirements" rather than explicit numerical acceptance criteria. The implied acceptance criteria are that the device performs within acceptable limits for the given test, as outlined by the testing approach and referenced standards/guidance.

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

The document does not explicitly state the numerical sample size for the test set for each individual study. It broadly refers to "data collected" and "analysis of the data collected."

However, it does indicate that whole blood samples were used for several studies (e.g., Assay Carryover, Detection Capability, Whole Blood Repeatability, Site-to-Site Variability).

Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal validation studies conducted by the manufacturer, Beckman Coulter Inc., based in Miami, FL. There is no indication of retrospective or prospective data collection for the test sets.

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

This information is not provided in the document. The studies listed are primarily focused on the analytical performance of the flow cytometer and software, not on subjective interpretations requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the studies are focused on the analytical performance and comparison to a predicate device, there is no mention of adjudication methods typically associated with human interpretation or subjective assessments.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically evaluates diagnostic accuracy with human readers, with and without AI assistance. The Navios EX Flow Cytometry System is an automated laboratory device, and its validation focuses on analytical performance and equivalence to a predicate device, rather than human interpretation aided by AI.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance evaluation was done. The studies listed (e.g., Laser Performance, Instrument Carryover, Linearity, Detection Capability, Precision, Method Comparison) directly assess the performance of the Navios EX Flow Cytometry System (instrument and software) without human intervention in the result generation process. The device's "automated analysis and results" indication for the Navios EX tetra Software also implies standalone capability.

7. Type of Ground Truth Used

The ground truth for most studies appears to be based on:

• Established analytical methodologies: Performance is evaluated against known physical properties (e.g., linearity of fluorescence, stability of laser), or against established and validated methods (e.g., the predicate device for method comparison, or control materials for precision).
• Performance specifications: The device is expected to meet certain predefined specifications (e.g., for carryover, detection limits).
• Published values: For the "Adult Reference Interval" study, the established intervals were confirmed to be "consistent with published values."

There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth for these analytical performance studies.

8. Sample Size for the Training Set

This information is not provided in the document. The Navios EX system is an update to an existing device (Navios Flow Cytometer). While the Navios EX tetra Software has "minor modifications implemented to address differences in select data patterns seen on the Navios EX," it's unclear if these modifications involved a distinct "training set" in the machine learning sense, or if "training" refers more to software development and tuning against internal data. Given the context of a 510(k) for an automated lab instrument, it's more likely the latter, and explicit machine learning training set sizes are typically not detailed in such submissions unless the AI component is a central, novel feature requiring extensive independent validation.

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

This information is not provided in the document. As noted above, the concept of a "training set" and its associated ground truth establishment methods are not explicitly discussed in this 510(k) summary, likely because the primary validation focuses on the analytical performance and substantial equivalence of the instrument system, rather than a novel, data-driven AI algorithm requiring extensive training data. If software algorithm adjustments were made, the "ground truth" for those adjustments would likely derive from internal testing and expected performance based on the predicate device's behavior.

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 (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.

The provided document is a 510(k) premarket notification for the "Navio" surgical system, focusing on updates to its Total Knee Arthroplasty (TKA) software and support for additional implants. This document details non-clinical testing performed to establish substantial equivalence to a predicate device, rather than a standalone clinical study to prove novel device performance.

Therefore, the information regarding acceptance criteria and a study proving those criteria are met is derived from the non-clinical (bench) testing described in the submission, which aimed to demonstrate that the updated device is as safe and effective as its predicate.

Here's the breakdown of the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table. However, the conclusion section implies the key acceptance criterion is that the total knee implant placement accuracy using the new "Bur All" method of bone removal is "acceptable and similar" to the implant placement accuracy required for unicondylar and patellofemoral implant placement. It also states that the placement accuracy using the TKA cut guides (including the new Tibia Twin Peg cut guides) is "acceptable and similar" to previous submissions.

The "reported device performance" is qualitative and states that these criteria were met.

Analysis of the Study and Ground Truth Establishment

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

   • Test Set Sample Size: "Simulated knees (sawbones)" and "cadaver laboratory testing" were used. The exact number of simulated knees or cadavers is not specified in the provided document.
   • Data Provenance: The testing was non-clinical, conducted in a laboratory setting. No country of origin for the cadavers or sawbones is specified, nor is whether the data is retrospective or prospective, as it's a bench test.

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

   • "Trained surgeons and technical support personnel" performed the verification accuracy testing and usability testing.
   • The number of surgeons/personnel is not specified.
   • Their specific qualifications (e.g., years of experience) are not detailed beyond "trained surgeons and technical support personnel."

3. Adjudication method for the test set:

   • The document does not describe an adjudication method for establishing ground truth or evaluating the results of the non-clinical tests. This is typically more relevant for studies involving human interpretation or subjective measurements.

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:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "No human clinical testing was conducted to determine safety and effectiveness of the NAVIO system." (K170360, Page 10). The study described is a non-clinical bench test confirming the performance of the device itself and its updated features.

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

   • The primary evaluation described is a "human-in-the-loop" test, as "Trained surgeons and technical support personnel performed verification accuracy testing using simulated knees (sawbones) and cadaver laboratory testing." The device is intended to assist a surgeon. The accuracy testing evaluated the system's ability to achieve "acceptable" implant placement when operated by a surgeon.

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

   • Given the nature of the device (a surgical navigation and burring system) and the non-clinical testing, the ground truth for "accuracy" would likely be based on engineering measurements or predefined geometric targets. This means comparing the actual bone removal or implant placement (as measured by precision instruments on sawbones/cadavers) against the software-defined surgical plan/target. The "acceptable and similar" criteria suggest a comparison to known accurate outcomes for previous versions or similar surgical methods.

7. The sample size for the training set:

   • The document does not mention a training set sample size. This submission is for updates to an existing system ("enhancements to the NAVIO system TKA software"), suggesting the core algorithms were likely developed and "trained" (if machine learning was involved, which is not indicated for this specific system update in the document) previously. The current submission focuses on verifying the impact of software enhancements and new implant support through non-clinical testing.

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

   • As no training set is discussed, the method for establishing its ground truth is not provided. The system uses "established technologies of navigation... to aid the surgeon in establishing a bone surface model... and in planning the surgical implant location, based on intraoperatively-defined bone landmarks and known geometry of the surgical implant." This suggests a reliance on precise geometric modeling and established anatomical landmarks rather than a machine learning model requiring a traditional "training set" with ground truth labels in the typical sense.

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 (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.

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 the acceptance criteria and a study proving the device meets these criteria for the Navio™ system, specifically for its expanded indication of placing inlay patellofemoral implants.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for the expanded indication seem to be demonstrating that the accuracy for inlay patellofemoral implant placement is comparable to or better than the accuracy previously established for onlay patellofemoral components with the predicate device.

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

• Sample Size: Not explicitly stated as a number. The testing involved "simulated knees (sawbones) and cadaver lab testing." The number of sawbones or cadavers used is not specified.
• Data Provenance: The testing was "nonclinical testing" and involved "simulated-use testing included testing in simulated knees (sawbones) and cadaver lab testing." This implies prospective, controlled lab experiments rather than retrospective patient data. The country of origin is not explicitly stated, but given the FDA submission, it's likely U.S.-based or regulated.

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

• Number of Experts: Not explicitly stated. The text mentions "Users included surgeons, physician's assistants, and technical support personnel." It doesn't specify how many of each, nor how many were involved in establishing "ground truth" (which seems to be implicitly defined by the system's ability to achieve specified placement accuracy and these users' successful operation of the device).
• Qualifications: "Surgeons," "physician's assistants," and "technical support personnel" who were "adequately trained" on the Navio system. Specific years of experience or board certifications are not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The determination of "successful" placement was "per Blue Belt Technologies' specifications and implant manufacturer's specifications." This suggests an objective measurement against predefined targets rather than a human consensus-based adjudication for ground truth.

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

• MRMC Study: No. The study described is a non-clinical, performance-based test, not an MRMC study comparing human readers with and without AI assistance. The device is a surgical navigation system, not an AI for image interpretation.

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

• Standalone Performance: Not directly applicable in the typical sense for an image-analysis AI. The Navio system inherently involves "human-in-the-loop" as it's a surgical assistance system ("intended to assist the surgeon"). The accuracy measurements (RMS placement error) represent the system's performance when used by a human. However, the control algorithms for bur retraction/speed are standalone in their operation relative to the software-defined spatial boundaries. The accuracy numbers reported (0.462 mm and 1.028°) reflect the end-to-end performance of the system in achieving the planned surgical outcome, which is highly dependent on the algorithm's control.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's performance (specifically the placement accuracy) was based on objective measurements against predefined specifications. This is derived from the "Blue Belt Technologies' specifications and implant manufacturer's specifications." For surgical navigation systems, this usually involves measuring the deviation of the actual performed cut or implant placement from the pre-planned surgical model within controlled lab settings (e.g., using metrology tools or comparing post-procedure scans to planned models).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not provided. This document describes a 510(k) submission for a medical device (surgical navigation system), which is a defined hardware/software product. It is not an AI model that undergoes "training" in the machine learning sense with a distinct training dataset. The device's "training" in a developmental context would involve iterative design, development, and testing cycles, but not a "training set" of data in the way an AI algorithm uses for learning.

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

• Ground Truth for Training Set: Not applicable, as this is not a machine learning AI model with a training set. The "ground truth" for the device's design and development would have been established through engineering specifications, biomechanical data, anatomical models, and surgical requirements derived from established medical knowledge and clinical practice.

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 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."

Ask a specific question about this device

The Navios Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It can be used in conjunction with the following monoclonal antibody reagents and software package:
• CYTO-STAT letraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CYTO-STAT terrCHROME CD45-FITC/CD56-F • C Y (O-S FAT TetraCHKOME CD4-FFTCCO4+KD7/CDV-Fc2/CD3 P ovide identification and numeration of CD3+CD4+CD4+CD4+CD4+CD4+ KDI/CDI9-ECD/CD3+CS monocolal antibody reagains. There reges and absolute counts in peripleral whole blood. Absolute method) CD3+CD8+, CD3+, CD19+ and CD3-CD3+ Tymphoeyto percomes (single platform lections of the may be in closing acrescription of parient counts may be celermined by the Navio Cyclinece asng I to "Outlier" (o" on the in the immunologic assessment of patients having or suspected of having immune deficiency.
• Navios tetra Software for automated and results with CYTO-STAT terraCHRONE CD45-FFTC/CD4-RD/VCD8-ECD/CD3-FCD/CD3-• Navios letta Soltware for adionated and results will of 10 0 010 11:40 pm
PC5 and CYTO-STAT ietraCHROME CD45 FITC/CD56-RDI/CD19-ECD/CD3-PCS monoclonal antibody reagents.
PC
Navios Software may be installed on an independent computer workstarion for off issues of listed of line against must he Navios Soltware may be installed on the incependent compaise frectorial and software package listed above. The off-line analysis must be performed in accordance with the product labeling.

The Navios tetra Software is intended for use as an in vitro diagnostic device for immunophenoyping with CYTC/CDS6 RD/A The Navios tera Software is mielided to use as an in Thir Glightshouse on minutes of the Subsition of the National Provincial Provinces of CD19-FITC/CD56-RDI/CD19-ECV/ CD3-PC5 monoclonal antibody reagents on the Navios Flow Cytometer.
It provides automated analysis and results for the identification and enumeration of CD3+CD4+, CD19+, CD19+, and If provides and results for the nemation and while blood. Absolute counts may be determined by the except of the CD3+CD5+ iymphocyte percentages and alsolute counts in perfined in separate hematology results (dual Navios now cycomerer use in the immunologic assessment of patients having or suspected of having immune deficiency.
platform method). It is indicated for use in the immunolog

Flow-Set Pro Fluorospheres is a suspension of fluorescent microspheres used as an aid in standardizing forward scatter, side scatter, and fluorescence detectors (FL1-4) on the Cytomics FC 500 and Navios Flow Cytometers.

The Navios Flow Cytometer system is composed of the following components:

• Navios Flow Cytometer .
• Navios tetra Software .
• Navios Software (off-line analysis tool) .
• Flow-Set Pro Fluorospheres .
• CYTO-STAT teiraCHROME reagents .
• COULTER IMMUNOPREP Reagent System .
• TQ-Prep Workstation (Accessory for Sample Preparation) .
• PrepPlus™ 2 Workstation (Accessory for Sample Preparation) .

The Navios Flow Cytometer uses flow cytometric principles to determine qualitative and quantitative measurements of biological and physical properties of cells and other particles. These properties are measured when the cells pass through the laser beam(s) in single file.

The Navios tetra software is an optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results for tetraCHROME reagents; this application cannot be modified by the user.

The Navios Flow Cytometry System also offers an optional standalone offline software package, Navios software, which may be installed on an independent computer workstation for off-line analysis of listmode files generated by the Navios Flow Cytometer with tetraCHROME reagents and Navios tetra software according to the product labeling.

tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CYTO-STAT reagent provides identification and enumeration of CD3+CD4+, CD3+CD8+, and CD3+ lymphocyte percentages and absolute counts in peripheral whole blood. CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 reagent provides identification and enumeration of CD3+, CD19+ and CD3-CD56+ lymphocyte percentages and absolute counts in peripheral whole blood.

Flow-Set Pro Fluorospheres is a suspension of fluorospheres with uniform and stable size and fluorescence intensity. The stability of these product parameters allows for the standardization of light scatter and fluorescence intensity instrument settings.

The COULTER ImmunoPrep Reagent System is comprised of 3 ready-to-use reagents: Reagent A lyses the red blood cells, Reagent B buffers the solution and stops the lysing process, and Reagent C fixes the cells. This reagent system provides a rapid, no-wash, standardized, whole blood lysing solution for sample to sample, and laboratory to laboratory reproducibility.

The Navios Flow Cytometer uses sample preparation devices as part of the overall workflow system. The COULTER TQ-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for quantitative immunofluorescence measurements on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

Here's a breakdown of the acceptance criteria and study information for the Navios Flow Cytometer System, based on the provided text.

Acceptance Criteria and Device Performance

The submission details several studies conducted to demonstrate the performance of the Navios Flow Cytometer system. The "Study Results" column in the table below directly indicates if the device met acceptable results for the respective criteria.

Study Information

The document is a 510(k) summary, which typically provides a high-level overview of validation studies rather than detailed protocols. As such, some specific details like exact sample sizes for training/test sets, data provenance, and expert qualifications are not explicitly stated in the provided text.

1. 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 explicitly stated in the provided text. The "Accuracy" study mentions using "Patient Samples" based on CLSI EP9-A2. The "Precision" study used "Whole Blood Repeatability." The "Manual Pipette vs. PrepPlus 2 Method Comparison" also used "specimens." However, the exact number of samples or patients for any of these studies is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective validation studies conducted by the manufacturer, Beckman Coulter, Inc.

2. 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 explicitly stated. Given that the device is an "Automated Differential Cell Counter" for immunophenotyping, the ground truth would likely be established through a recognized reference method performed by trained laboratory personnel on an established, validated system. The document compares performance to a predicate device (Cytomics FC 500 with tetraCXP software), implying that the predicate's results served as a comparative "ground truth" or reference.

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

• Not explicitly stated. Adjudication methods are typically relevant for subjective interpretations (e.g., image analysis by multiple radiologists). For quantitative measurements from a flow cytometer, the ground truth is usually derived from a reference method with inherent analytical precision, rather than adjudicated expert opinions.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI assistance. The Navios system is an automated flow cytometer with software for automated analysis (Navios tetra software). The comparisons are between the new device and a predicate device (another automated system), and between different methods on the same device (e.g., single vs. dual platform absolute counting) or different sample preparation methods. This is not a human-in-the-loop AI system where human reader performance would be the primary metric.

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

• Yes, standalone performance was assessed. The entire suite of performance studies (Accuracy, Precision, Linearity, Carryover, Limits, etc.) for the Navios Flow Cytometer and its associated Navios tetra software (which is an "optional locked algorithm application plug-in that is designed for the Navios flow cytometer. It provides automated analysis and results") represent standalone algorithm performance. The device is intended "for automated analysis and results."

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The ground truth for the analytical performance studies (Accuracy, Precision, Linearity, etc.) appears to be based on:
  • Comparison to a predicate device: The accuracy study directly states "comparable results to the predicate device." The predicate device (Cytomics FC 500 with tetraCXP software) represents an established and accepted method for immunophenotyping.
  • Established analytical methods and guidelines: Studies refer to CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., CLSI EP9-A2 for Method Comparison, CLSI EP5-A2 for Precision, CLSI EP06-A for Linearity). These guidelines define methods to establish the true analytical performance characteristics of a quantitative diagnostic device, implicitly establishing a "true value" or "ground truth" to compare against.
  • Reference Intervals: Reference intervals were established for the device, which involves testing healthy populations to define normal ranges.

7. The sample size for the training set

• Not explicitly stated. The document describes performance studies, which are typically conducted on independent test sets after an algorithm has been developed and trained. Information about specific training set sizes used to develop the "Navios tetra software" algorithm is not provided in this regulatory summary.

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

• Not explicitly stated. As this is a 510(k) summary focused on post-development performance validation, details on the training process and ground truth establishment for the development phase of the "Navios tetra software" algorithm are not included. Generally, for such systems, training data would be meticulously characterized using established laboratory methods or reference instruments, with expert review to ensure accuracy of the labels.

Ask a specific question about this device