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The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS System proposed in this submission is a modification of the ExactechGPS System cleared per 510(k) #K213877.

The ExactechGPS System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The ExactechGPS System works with ExactechGPS hardware trackers that communicate intraoperative data to the ExactechGPS hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.

The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.

This FDA 510(k) clearance letter and summary primarily address mechanical and electrical modifications to an existing device, the ExactechGPS® System. It focuses on demonstrating that these hardware changes do not significantly alter the performance of the device for its intended use in stereotaxic surgery for total knee arthroplasty (TKA).

Therefore, the document does not contain the detailed information typically found in acceptance criteria and study designs for Artificial Intelligence/Machine Learning (AI/ML) based medical devices. The performance data section lists general function tests, electrical safety, EMC compatibility, photobiological safety, and sterilization validation, which are standard for hardware modifications, not AI/ML algorithm validation.

Based on the provided text, I cannot extract the information required for a study proving an AI/ML device meets acceptance criteria. The document pertains to a hardware modification of a surgical navigation system, not an AI/ML component or software that analyzes data for diagnostic or prognostic purposes, which would necessitate the criteria you've outlined.

Specifically, the document states:

• "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used."
• "The proposed ExactechGPS system have the same general features and dimensions, with the same technology and performances."
• "The redesigned electronic card only resolves obsolescence issues with no impact on user, global performances and safety."

This indicates that the focus of the submission was to show non-inferiority or equivalence of the modified hardware to its predicate, rather than to prove a new performance claim for an AI/ML component.

Therefore, I cannot fulfill your request to provide:

• A table of acceptance criteria and reported device performance (in the context of AI/ML).
• Sample sizes for a test set or training set (for AI/ML).
• Details on experts, adjudication methods, MRMC studies, or standalone performance (for AI/ML).
• Ground truth establishment methods (for AI/ML).

The provided text deals with the ExactechGPS® System, which is a surgical navigation system (stereotaxic instrument). The submission is for hardware modifications to an existing cleared device, primarily to address obsolescence of sub-components (optical localizer, tablet, wireless feature). The core claim is that these hardware changes do not alter the fundamental performance or intended use of the device.

The "TKA Pro software application" is mentioned as being compatible with the modified system, but the document does not describe any AI/ML components within this software application or any studies validating AI/ML performance. The performance data listed (electrical safety, EMC, etc.) are typical for hardware evaluations, not AI/ML model validation.

In summary, this document is a 510(k) clearance for hardware modifications to a surgical navigation system, not an AI/ML device, and thus does not contain the information requested about AI/ML acceptance criteria or an AI/ML study.

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The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the requred anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.

The ExactechGPS Total Ankle Navigation is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

The ExactechGPS Total Ankle Application proposed by Blue Ortho in this submission is new clinical software application.

The ExactechGPS Total Ankle Application (TAA) system is intended to be used during stereotaxic surqical procedures to aid the surgeons in locating anatomical structures and aligning the endoprosthesis with the patient bony anatomy provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Ankle Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure. The ExactechGPS Total Ankle Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model.

It encompasses two software applications:

• The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
• -The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.

The ExactechGPS Total Ankle Navigation is working on the Blue Ortho ExactechGPS System cleared per 510(k) #K213877. The system is composed of ExactechGPS Trackers, which are rigidly fixed to the patient bony anatomy, and other components (ExactechGPS Station and ExactechGPS camera) that are not in contact with the patient.

The provided text is a 510(k) FDA clearance letter and a summary of safety and effectiveness for a medical device (ExactechGPS® Total Ankle Application). While it discusses indications for use, device description, and comparison to a predicate device, it explicitly states, "This submission includes or references the following non-clinical testing: Software verification testing to ensure all design outputs meet all specified requirements; Software validation to ensure software specifications conform to user needs and intended uses."

Crucially, the document does NOT contain detailed performance data to establish acceptance criteria or describe a specific study proving the device meets those criteria with statistical rigor, using a defined test set, expert ground truth, or adjudication methods. It mentions "non-clinical testing" for software verification and validation, but these are general statements about software development processes, not specific clinical or even simulated performance studies with quantitative results against defined acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria beyond general software quality statements, nor does it report quantitative performance.
• Sample size used for the test set and the data provenance: No test set or data provenance is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on ground truth establishment or experts is provided.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a navigation system, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant. The document does not describe any human-in-the-loop performance studies or comparative effectiveness studies.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes a surgical navigation system, which inherently involves human interaction. There's no mention of a "standalone" algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth definition is provided.
• The sample size for the training set: No training set or machine learning model is explicitly described as part of the performance evaluation. The device uses patient CT-scan data for reconstruction, but this is not delineated as a "training set" in the context of AI model development that would typically require such detail.
• How the ground truth for the training set was established: Not applicable, as no training set for an AI model is described.

In summary, the provided document is a regulatory approval letter and a summary of the device's characteristics and intended use, not a detailed study report on device performance against specific, quantifiable acceptance criteria. It states that safety and effectiveness are supported by "non-clinical testing" for software verification and validation, but these are high-level statements without the specifics requested in your prompt.

Ask a specific question about this device

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.

The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.

The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.

This document describes the ExactechGPS® System, a surgical navigation system, and its modifications. While the document mentions general performance tests, electrical safety, EMC compatibility, photobiological safety, biocompatibility, and cleaning/sterilization validation, it does not provide the specific details required to fully address your request regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/human-in-the-loop system.

The device described is a "stereotaxic instrument" and mentions a "TKA Pro software application" for Total Knee Arthroplasty, aiding surgeons in locating anatomical structures and aligning endoprostheses. This implies a core functionality related to precise surgical guidance.

Given the information provided in the document, here's what can be extracted and what is missing:

Information Provided:

• Device Name: ExactechGPS® System
• Intended Use: "intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty."
• Modifications: New set of ExactechGPS Trackers V2 (different architecture, updated electronic card, InfraRed bandpass filter) and compatibility with only the TKA Pro clinical software application (whereas the predicate was compatible with TKA Pro and TKA Plus).
• Claimed Impact of Modifications: "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used: The proposed ExactechGPS Trackers V2 have the same general features and dimensions, with the same technology and performances. The redesigned electronic card only resolves obsolescence issues with no impact on user, performance and safety. The new InfraRed bandpass filter only improves communication reliability."
• Non-Clinical Testing: General Functions tests, Electrical Safety (IEC 60601-1), EMC Compatibility (IEC 60601-1-2), Photobiological Safety (EN 62471), Biocompatibility (ISO 10993-1:2018), Cleaning and Sterilization Validation (ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020, AAMI TIR30:2011/(R) 2016).

Information NOT Provided (or not in sufficient detail):

• Specific Acceptance Criteria and Performance Data for Surgical Accuracy/Clinical Outcome: While "General Functions tests" are mentioned, no quantitative acceptance criteria for surgical accuracy (e.g., angular or translational precision of component placement) or specific performance results (e.g., mean angular deviation, success rate) are presented in a table format as requested. The document states "the proposed changes do not alter significantly the performances," implying a comparison to the predicate, but no specific performance metrics are given.
• Sample Size for Test Set and Data Provenance: Not specified for any study related to the device's functional performance in surgical guidance. The document mentions "test bench testing" but no details on the size or nature of the test set.
• Number of Experts and Qualifications for Ground Truth: Not applicable as no reader study or expert-based ground truth establishment is described for the device's performance. The device is a navigation system, so its "ground truth" would presumably be the physical reality of component alignment or anatomical structure location, measured by highly accurate metrology, rather than expert interpretation of images.
• Adjudication Method for Test Set: Not applicable.
• MRMC Comparative Effectiveness Study: Not mentioned or implied. This device is a navigation system, not an AI diagnostic tool primarily assisting human readers in interpreting images.
• Standalone Performance (Algorithm Only): The device functions as a system with hardware and software; standalone algorithm-only performance is not directly relevant in the way it might be for an AI diagnostic algorithm.
• Type of Ground Truth Used: For a navigation system, ground truth would typically come from highly accurate metrological measurements of physical objects or cadaveric studies, not expert consensus on images or pathology. This exact type of ground truth is not explicitly detailed.
• Sample Size for Training Set: Not specified. It's unclear if "training" in the machine learning sense applies to this system's development, or if it refers to calibration/validation data for the navigation system.
• How Ground Truth for Training Set was Established: Not specified.

Based on the provided document, here's a structured response indicating available information and significant gaps:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only mentions "test bench testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing was conducted "in-house and by accredited testing laboratories."

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

• Not applicable as no expert-based ground truth establishment or reader study is described for the performance claims. The device is a navigation system; its performance would likely be evaluated against physical measurements.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• No evidence of an MRMC study. The device is a surgical navigation system, not a diagnostic AI tool for image interpretation by human readers. Its primary function is to provide real-time guidance during surgery, not to enhance human interpretation of medical images.

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

• The document describes the device as a system of hardware (trackers, station) and software. The listed "performance data" refers to general system functions and regulatory compliance (electrical safety, EMC, etc.). It does not detail a standalone algorithm-only performance study related to its core navigation accuracy. The "TKA Pro software application" is part of the system, not presented as a standalone AI for diagnosis.

7. The Type of Ground Truth Used:

• For a surgical navigation system, the ground truth for functional performance (like accuracy of component placement) would typically be established using highly accurate metrological measurements on physical models, cadavers, or potentially intraoperative measurements. This document does not specify the exact type of ground truth used for "General Functions tests" or "test bench testing" related to the navigation's accuracy. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set:

• Not specified. It's unclear if "training set" refers to a machine learning training set or calibration data for the navigation system. The document does not describe an AI model that would require a distinct "training set" in the context of deep learning.

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

• Not specified and likely not applicable in the context of an AI training set as described in the prompt, as the device is not presented as a deep learning AI diagnostic tool.

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The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.

The Exacted GPS Total Shoulder Navigation is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

The ExactechGPS Total Shoulder Application proposed in this submission is a modification of the ExactechGPS Total Shoulder Application cleared per 510(k) #K173372.

The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to quide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.

In the predicate device, the planning step was only indicated for pre-operative planning of the dlenoid part of the Equinoxe system. This submission proposes the addition of the humeral component. Therefore, the proposed ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.

The proposed ExactechGPS Total Shoulder Planning and Navigation Applications integrate some other modifications compared to the predicate device. These modifications are documented in Letter to Files.

The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology. No changes to the hardware platform or system accessories are proposed by this submission.

The provided text is a 510(k) summary for the ExactechGPS Total Shoulder Application. It describes a medical device and its proposed modifications, claiming substantial equivalence to a predicate device. However, it does not include detailed performance data, acceptance criteria, or study methodologies that would allow for a comprehensive description as requested. It only broadly states that "testing information demonstrating safety and effectiveness... is supported by testing that was conducted in-house" and lists general types of software testing (verification and validation).

Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided document. I will focus on what can be inferred or directly stated from the text.

Here's an attempt to answer your questions based on the provided document, highlighting where information is missing:

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

The document states: "Software verification testing to ensure all design outputs meet all specified requirements" and "Software validation to ensure software specifications conform to user needs and intended uses."
However, the specific acceptance criteria and the reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity, etc.) are not provided in this 510(k) summary.

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

This information is not provided in the document. The text only mentions "testing that was conducted in-house."

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

This information is not provided in the document.

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

This information is not provided in the document.

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

The document describes a "surgical navigation system" and "preoperative planning feature," but does not indicate that an MRMC comparative effectiveness study was performed or that human readers' improvement with AI assistance was measured. The focus is on the device's functionality in aiding surgical planning and navigation. Therefore, this information is not applicable or not provided in the context of this 510(k) summary.

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

The document mentions "software verification testing" and "software validation" which would typically involve testing the algorithm's performance in a standalone manner (e.g., accuracy of bone model reconstruction, implant placement) before integration with the surgeon's input. However, the specific results or detailed methodology for these standalone tests are not provided.

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

This information is not explicitly provided. Given the nature of a surgical planning and navigation system, ground truth would likely involve highly accurate imaging (e.g., high-resolution CT scans), anatomical measurements, and potentially expert anatomical review for validation of the reconstructed bone models and implant placements. However, the specific method for establishing this ground truth (e.g., expert consensus based on imaging, cadaveric studies with known anatomical landmarks) is not detailed in this summary.

8. The sample size for the training set

The document describes modifications to an existing device and its functionalities (e.g., extending planning to the humeral component, extending segmentation capabilities). It does not explicitly mention a deep learning or machine learning system that would require a distinct "training set" in the common AI sense. If the "software" relies on rule-based programming or image processing algorithms, a traditional "training set" might not be applicable in the same way as for a neural network. If there was any machine learning involved, the training set size is not provided.

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

As the existence or nature of a training set is unclear, the method for establishing its ground truth is also not provided.

Ask a specific question about this device

The Exactech GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS System proposed in this submission is a modification of the ExactechGPS System cleared per 510(k) #K152764.

The ExactechGPS System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The ExactechGPS System works with ExactechGPS hardware trackers that communicate intraoperative data to the ExactechGPS hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery. The camera component that communicates with trackers is compliant with EN 62471 (Photobiological safety testing).

The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology.

The provided document does not contain details about specific acceptance criteria, reported device performance metrics, or a study that evaluates these metrics for the ExactechGPS System. The document focuses on regulatory approval (510(k) clearance) for a modified version of an existing device, highlighting changes to hardware and software, and confirming its substantial equivalence to a predicate device based on general functionality, safety, and electromagnetic compatibility testing.

Therefore, I cannot provide the requested table, sample sizes, ground truth information, or details about MRMC studies.

Here's an overview of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:
This information is not available in the provided text. The document states that "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used," and lists general testing categories like "General Functions tests to ensure design is fully verified and validated." However, specific quantitative acceptance criteria or reported performance figures are not detailed.

2. Sample Size Used for the Test Set and Data Provenance:
This information is not available in the provided text. The document mentions "test bench testing" but does not specify the sample size or the provenance of any data used for testing device performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not available in the provided text. Ground truth establishment is not discussed.

4. Adjudication Method for the Test Set:
This information is not available in the provided text. Adjudication methods are not discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
This information is not available in the provided text. There is no mention of an MRMC study or any comparison of human readers with or without AI assistance. The device in question ("ExactechGPS System") is an image-guided surgery system, not a diagnostic AI tool for image interpretation by human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The document describes the ExactechGPS System as an "image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons." This implies a human-in-the-loop system, where the device provides information to assist a surgeon. There is no mention of a standalone algorithm-only performance evaluation, as the device's function inherently involves human interaction during surgery.

7. Type of Ground Truth Used:
This information is not available in the provided text. The document refers to "General Functions tests to ensure design is fully verified and validated," but it does not specify how accuracy or performance was verified against a "ground truth" (e.g., pathology, outcomes data, or expert consensus).

8. Sample Size for the Training Set:
This information is not available in the provided text. The document does not mention a training set, as it describes a modification to an existing navigation system rather than a new AI model requiring a training phase in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided text, as no training set is mentioned.

Ask a specific question about this device

The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.

The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.

At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.

The provided text describes a 510(k) premarket notification for the ExactechGPS Total Shoulder Application. It focuses on a modification to the device, specifically the addition of a semi-automatic segmentation option for preoperative planning.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format and corresponding reported device performance values. It discusses the changes in a qualitative manner. The primary acceptance criterion appears to be demonstrating that the modified device, particularly the semi-automatic segmentation, does not negatively impact the overall performance and maintains substantial equivalence to the predicate device.

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

The document mentions "CT-scan data collected during clinical use" for system accuracy verification. However, it does not specify:

• The sample size used for this test set.
• The country of origin of the data.
• Whether the data was retrospective or prospective.

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

The document does not provide any information regarding the number of experts used, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the device's performance in preoperative planning and stereotaxic surgery, specifically the new semi-automatic segmentation feature.

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

The document refers to "software verification testing" and "software validation," which imply standalone algorithm testing. The semi-automatic segmentation is a feature of the algorithm designed for "planning only, and not for use during a navigated surgical procedure," suggesting its performance as an algorithmic tool is evaluated. However, specific performance metrics for the standalone algorithm are not detailed.

7. Type of Ground Truth Used

The document states "comparison of system outputs to CT-scan data collected during clinical use." This suggests the ground truth for validating system accuracy might be derived from:

• Clinical CT-scan data: Potentially representing actual patient anatomy or expert-verified segmentations based on these scans.
• The initial "manually conducted" segmentations by Blue Ortho could also serve as a ground truth baseline for comparison with the new semi-automatic method.

However, the specific nature of how "ground truth" was established (e.g., expert consensus on CT, pathology, or outcomes) is not explicitly detailed.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set (if any was used for the semi-automatic segmentation algorithm).

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

The document does not specify how the ground truth for the training set was established. It only mentions that the "segmentation step was manually conducted by Blue Ortho" at initial release, which implies manual segmentation could have been used for training data, but this is not explicitly stated.

Ask a specific question about this device

The ExactechGPS is intended for use during preoperative planning and during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

The ExactechGPS Total Shoulder Application is a modification of the Exactech GPS stereotactic navigation system designed to help guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure.

Like predicate Exactech GPS system software dedicated to use with total knee arthroplasty procedures, the ExactechGPS Total Shoulder Application works with Exactech GPS hardware trackers that communicate intraoperative data to the Exactech GPS hardware station to provide surgeons with real-time information on the position of patient anatomical structures and of instrumentation used to prepare patient bone during stereotaxic surgery.

The ExactechGPS Total Shoulder Application adds a preoperative planning feature, where surgeons use CT-scan images of patient bone with software models of Exactech Equinoxe implants to preoperatively plan procedures in a virtual environment prior to surgery.

The ExactechGPS Total Shoulder Application is used with the same ExactechGPS V2 station, trackers, and disposable kit hardware as the predicate ExactechGPS. This submission includes new surgical instruments dedicated to total shoulder arthroplasty.

The provided text describes a 510(k) premarket notification for the ExactechGPS® Total Shoulder Application. It outlines the device's indications for use, its description, and references non-clinical testing performed to establish substantial equivalence. However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document lacks specific quantitative acceptance criteria for accuracy, precision, or other performance metrics. It also does not detail a specific human-in-the-loop (MRMC) study or a standalone algorithm study with defined ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for the test set.

Based on the provided text, here's what can be extracted and what is missing:

Missing Information:

• A table of specific numerical acceptance criteria (e.g., accuracy +/- X mm, precision +/- Y degrees).
• Reported device performance against those specific numerical criteria.
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set.
• Qualifications of those experts.
• Adjudication method for the test set.
• Whether a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and if so, the effect size.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for quantitative performance evaluation.
• The sample size for the training set.
• How the ground truth for the training set was established.

Information that can be extracted from the provided text:

1. Acceptance Criteria & Reported Device Performance:

The document broadly states that "Software verification testing to ensure all design outputs meet all specified requirements" and "Software validation to ensure software specifications conform to user needs and intended uses, and that the particular requiremented through software can be consistently fulfilled" were performed.

Regarding device performance, it mentions:

• "System accuracy verification via bench testing to ensure the ExactechGPS Total Shoulder Application works with Exactech GPS hardware to display information to surgeons as intended"
• "System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens"
• "Overall system validation through simulated use via evaluation with cadaveric specimens"

However, the specific numerical acceptance criteria for accuracy (e.g., in mm or degrees) and the quantitative results of these tests are NOT provided in this document. It implies that certain accuracy thresholds were met, but the specific values are absent.

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: Not specified. The phrase "evaluation with cadaveric specimens" is used, implying multiple specimens, but the exact number is not given.
• Data Provenance: The cadaveric specimens imply real anatomical data. The company is based in France ("6 Allée de Bethléem 38610 Gières France"), so it's reasonable to assume the studies were conducted there or in collaboration with institutions in other countries, but the specific country of origin for the cadaveric data is not stated. The studies were likely performed retrospectively on collected cadaveric data, not prospectively in a clinical setting.

3. Number and Qualifications of Experts:

• Number of experts: Not specified.
• Qualifications of experts: Not specified. The testing involves "surgeons" in a simulated use context, but their experience or specific role in establishing ground truth is not detailed.

4. Adjudication Method:

• Not specified. Given the nature of the "system accuracy verification" tests, it's more likely that the "ground truth" was established through physical measurements on the cadaveric specimens and/or comparison to the source CT data, rather than through expert image review adjudication.

5. MRMC Comparative Effectiveness Study:

• No specific MRMC comparative effectiveness study is mentioned in the provided text. The testing described focuses on system accuracy and validation, not on how human readers/surgeons improve with the AI vs. without AI assistance. This device is a navigation system aiding a surgeon during a procedure, not primarily an AI algorithm for diagnostic image interpretation.

6. Standalone Performance (Algorithm Only):

• No specific standalone performance study is explicitly described in terms of an algorithm working without human interaction for a diagnostic or predictive task. The mentioned "System accuracy verification via comparison of system outputs to CT-scan data" relates to the device's ability to display information accurately based on CT data, which is a component of its overall function, but not typically reported as a "standalone algorithm" performance in the context of diagnostic AI. The device is intended for human-in-the-loop use (surgeon guidance).

7. Type of Ground Truth Used:

• For the "System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens," the ground truth was likely established by:
  • High-resolution CT-scan data: Used as the reference for anatomical structures.
  • Physical measurements/known geometries: For bench testing and potentially for certain structures on the cadaveric specimens.
  • Simulated surgical outcomes: Comparing the system's guidance to a desired anatomical alignment.
  • It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic AI.

8. Sample Size for Training Set:

• Not specified. The document does not describe the specific development of an AI algorithm with a training set. The device is a "stereotaxic navigation system" and "preoperative planning tool," which suggests a more traditional software engineering approach (rules-based, image processing, 3D reconstruction) rather than a deep learning model requiring vast training datasets and associated ground truth.

9. How Ground Truth for Training Set was Established:

• Not applicable / not specified. As above, the text doesn't describe a machine learning model that would require a "training set" with established ground truth in the typical AI sense. The "ground truth" here refers to the accuracy of the system's displayed information relative to real anatomy or CT data.

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The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for primary and revision Total Knee Arthroplasty.

The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for orthopedic surgical procedures intended to be used to intraoperatively assist surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The provided document describes the EXACTECH GPS, a stereotaxic instrument intended for use during total knee arthroplasty to locate anatomical structures and align endoprostheses. The product is a submission for changes to the original EXACTECH GPS (K100742), specifically regarding sterile battery sterilization packaging and the introduction of Revision Total Knee Application software.

The document includes a summary of Safety and Effectiveness for the EXACTECH GPS, outlining testing related to the new Revision Total Knee Application software. This testing includes Design Verification (including accuracy testing) and Design Validation (including cadaveric sessions) to demonstrate substantial equivalence to the predicate device.

However, the document does not explicitly provide a detailed table of specific acceptance criteria and reported device performance metrics for the software's accuracy, nor does it detail the specific study methodology or results proving the device meets these criteria. The text only broadly states that "performance specifications: the proposed modifications do not affect device accuracy and/or performance."

Therefore, based on the provided text, I cannot complete points 1 through 9 with specific quantitative data. The information is not detailed enough to extract those specifics.

The document states:

• Testing: "Revision Total Knee Application software: - Design Verification (including accuracy testing) - Design Validation (including cadaveric sessions)"
• Substantial Equivalence Conclusion: "Proposed device was tested during engineering studies and testing ensures Results of engineering studies and cadaveric sessions referenced in this 510(k) submission demonstrate the proposed EXACTECH GPS is substantially equivalent to the predicate."

This implies that some form of accuracy testing was performed during Design Verification and usability/effectiveness testing in cadaveric sessions during Design Validation. However, the specific metrics, thresholds, sample sizes, and expert details for these studies are not disclosed in this summary.

In summary, while the document confirms that accuracy and cadaveric studies were performed to support the device's substantial equivalence, it does not provide the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria, study design, and performance metrics.

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The BLUE NAVIGATION SYSTEM is intended for use during stereotaxic surgery to help surgeons locate anatomical structures and align endoprostheses. It is specifically indicated for Total Knee Arthroplasty.

The BLUE NAVIGATION SYSTEM is an image guided, or navigation, system for orthopedic surgical procedures. It is intended to intraoperatively compute and display information such as distances and angles related to surgical instrument position. It provides this data to help surgeons make decisions, and is not intended to make surgical decisions or replace surgical actions. The station is composed of an optical localizer system, a computer, and a screen. The localizer tracks in real time the positions of trackers rigidly attached to patient bone or surgical instruments. The BLUE NAVIGATION SYSTEM is imageless, meaning there is no need for preoperative images (CR or MRI), but is based on intraoperative patient anatomical landmarks that are digitized at the beginning of the procedure by the surgeon. The station uses these landmarks to compute useful information that is displayed on a screen to help surgeons position prosthetic components.

The provided document focuses on the 510(k) summary for the BLUE NAVIGATION SYSTEM, detailing its intended use, comparison to predicate devices, and a general statement about performance testing. However, it does not provide specific quantitative acceptance criteria or detailed results of a study demonstrating the device meets such criteria.

The document states:
"Analyses show that the accuracy and performance of the system was adequate for its intended use and not reduced in comparison the predicate devices."
"BLUE NAVIGATION SYSTEM was tested in a non-clinical setting and anatomical testing) to assess that no new safety and effectiveness issues were raised in the device."

This is a general statement of compliance, not a presentation of specific acceptance criteria and the data to show they were met.

Therefore, for most of your questions, the information is not available in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only mentions "non-clinical setting and anatomical testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

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

4. Adjudication Method for the Test Set:

• Not specified.

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

• Was it done? Not mentioned. The focus is on the device's standalone performance relative to predicate devices.
• Effect size: Not applicable, as an MRMC study is not mentioned.

6. Standalone (Algorithm Only) Performance Study:

• Was it done? Yes, implicitly. The "Performance Testing" section describes testing of the "BLUE NAVIGATION SYSTEM" itself to assess its accuracy and performance. This implies a standalone evaluation of the device's capabilities without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

• Not explicitly stated. Given the context of an imageless navigation system relying on "intraoperative patient anatomical landmarks that are digitized," the ground truth for accuracy measurements would likely involve physical measurements or highly accurate reference systems in the non-clinical and anatomical testing settings, rather than expert consensus on images or pathology.

8. Sample Size for the Training Set:

• Not specified.
• The device is "imageless," meaning there's "no need for preoperative images (CR or MRI)," which typically form the basis of training sets for image-based AI. This suggests that if machine learning is involved, the 'training' might be related to internal calibration or statistical models derived from engineering data, rather than a traditional medical image training set. However, the document does not elaborate on any machine learning or AI components specifically, beyond its function as a navigation system.

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

• Not applicable as a traditional training set with established ground truth, as understood in machine learning contexts, is not described or implied. If there are internal models, their 'ground truth' would be derived from precisely engineered physical measurements during development and calibration, rather than clinical consensus.

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