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The ExamVue Apex flat panel x-ray detector system is indicated for use in general radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems. The Exam Vue Apex flat panel x-ray detector system is not indicated for use in mammography.

The ExamVue Apex flat panel x-ray detector system consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, combined with a single controlling software designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ExamVue Apex flat panel x-ray detector system captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. ExamVue Apex flat panel x-ray detector system incorporates the ExamVue Duo software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ExamVue Apex flat panel x-ray detector system use a Si TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image.

The three available models are:

EVA 14W, with a 14x17in (35x43cm) wireless cassette sized panel
EVA 17W, with a 17x17in (43x43cm) wireless cassette sized panel
EVA 10W, with a 10x12 (24x30cm) wireless cassette sized panel

The provided text describes the regulatory clearance of a digital X-ray detector system, the "ExamVue Apex," and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or an analytical study proving the device meets those criteria, as one would typically find for an AI/ML medical device submission with defined performance metrics (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence through:

• Bench Testing: Comparing engineering specifications like resolution, sensitivity, and dynamic range to the predicate device.
• Software Validation: Ensuring the software adheres to relevant standards (IEC 62304) and performs expected functions.
• Clinical Testing: An ABR-certified radiologist visually evaluating image quality as equivalent or better than the predicate device.

Therefore, many of the requested fields regarding a detailed statistical study (sample size, ground truth, expert adjudication, MRMC study, standalone performance) cannot be filled from the provided text because such a study, with quantitative acceptance criteria, does not appear to have been performed or reported in this 510(k) summary. The submission relies more on demonstrating equivalence through technical specifications and expert opinion on image quality rather than rigorous statistical performance criteria for an AI algorithm.

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

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

The provided text does not define explicit quantitative acceptance criteria for device performance in the typical AI/ML sense (e.g., a target sensitivity of X% or specificity of Y%). Instead, the "acceptance criteria" are implied by demonstrating "similar or greater imaging characteristics" compared to the predicate device and that the software "performs the same required basic functions."

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: Not specified. The clinical testing merely states "Clinical data was provided with the submission to demonstrate equivalence with the predicate device. This data includes images of all the relevant ROI." It doesn't quantify the number of images or patients.
• Data Provenance: Not specified (country, retrospective/prospective).

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)

• Number of Experts: "an ABR certified radiologist" (singular, implied to be one).
• Qualifications: "ABR certified radiologist." No mention of years of experience.

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

• Adjudication Method: Not specified. Since only one radiologist is mentioned, it's likely "none" in the sense of a consensus or adjudication process among multiple readers. The single ABR-certified radiologist provided the evaluation.

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 explicitly stated or described. This submission is for a general X-ray detector system, not specifically an AI-powered diagnostic algorithm designed to assist human readers. The "AI" mentioned is the software components related to image acquisition, processing, and management, not a diagnostic AI.

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

• Standalone Performance: Not applicable in the context of an AI diagnostic algorithm. This device is a digital X-ray detector system. Its "performance" refers to image quality and functionality, not a diagnostic output from an algorithm that would then require standalone performance metrics (e.g., sensitivity/specificity for disease detection). The software handles image processing, presentation, and storage, not automated diagnosis.

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

• Type of Ground Truth: The "ground truth" for the clinical testing was the visual evaluation of image quality by an ABR-certified radiologist. It's not a diagnostic ground truth (like pathology for cancer detection) but rather an assessment of whether the images produced by the new device are diagnostically acceptable and equivalent/superior to those from the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/not specified. This device is an X-ray detector and associated software for image acquisition and processing, not a deep learning AI model that requires a "training set" to learn features for interpretation. The software's development (as per IEC 62304) involves validation and verification, but not "training" in the machine learning sense.

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

• Ground Truth for Training Set: Not applicable. (See #8).

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The Exactech® TRULIANT® Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.

The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.

This document is a 510(k) Premarket Notification from the FDA regarding the Exactech® TRULIANT® Knee System. It does not describe an AI/ML device and therefore does not contain the specific information requested in the prompt about acceptance criteria for an AI model, such as performance metrics like sensitivity/specificity, AI model training/test sets, expert adjudication, or MRMC studies.

The document discusses the substantial equivalence of a medical device (a knee replacement system) to a legally marketed predicate device. The performance data presented relates to engineering and biocompatibility testing for a physical implant, not an AI algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

ExacTrac Dynamic (ETD) is a patient positioning and monitoring device used in a radiotherapy environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy treatment plans and the associated computed tomography (CT) data to determine the patient's planned position and compares it via oblique X-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment, the patient is monitored with a thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient movement. Positioning and monitoring are also possible in combination with implanted markers. By defining the marker positions, ExacTrac Dynamic can position the patient by using X-rays and thereafter monitor the position during treatment.

Additionally, ExacTrac Dynamic features a breath-hold (BH) functionality to serve as a tool to assist respiratory motion management. This functionality includes special features and workflows to correctly position the patient at a BH level and thereafter monitor this position using surface tracking. Regardless of the treatment indication, a correlation between the patient's surface and internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this technique is to treat the patient only during breath hold phases where the treatment target is at a certain position to reduce respiratory-induced tumor motion and to ensure a certain planned distance to OARs such as the heart. In addition to the X-ray based positioning technique, the system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has been used to position the patient).

The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the X-ray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).

The FDA 510(k) summary for Brainlab AG's ExacTrac Dynamic (2.0) and ExacTrac Dynamic Surface provides information regarding its performance testing to demonstrate substantial equivalence to its predicate device, ExacTrac Dynamic 1.1 (K220338).

Here is a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" side-by-side with "reported device performance" values for all aspects of the device. However, it does reference the AAPM Task Group 1472 guidelines as a reference for the accuracy of surface-based monitoring and indicates that specific tests aimed to verify that accuracy specifications were not negatively affected. From the "Bench Tests" section, we can infer the objectives of the tests and how performance was evaluated.

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

• Sample Size for Test Set: The document mentions the use of an "in-house phantom" for the Rigid Body Surface Monitoring Accuracy Test and "phantom treatment" for the Workflow & Accuracy Test. It does not provide specific numerical sample sizes (e.g., number of phantom instances, number of trials).
• Data Provenance: All testing appears to be retrospective (bench tests, phantom studies) and conducted internally (in-house phantom). There is no mention of data from human subjects or specific countries of origin.

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

This information is not provided in the document. The testing described focuses on device performance against physical standards (e.g., phantom, previous system performance) and referenced guidelines (AAPM Task Group 1472), rather than expert-established ground truth on clinical images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench and phantom tests, an adjudication method by experts is not described as it would be for clinical image interpretation studies.

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

No, an MRMC comparative effectiveness study was not reported. The document states, "No clinical testing was required for the subject device." The testing described focuses on the device's physical performance, accuracy, and workflow.

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

The described tests, specifically the "Rigid Body Surface Monitoring Accuracy Test," "Workflow & Accuracy Test ExacTrac Dynamic," "Response Time Measurement," and "Verification of the Radiation Isocenter Calibration," appear to evaluate the device's inherent performance characteristics, often in a controlled phantom environment. This implies a focus on the standalone capabilities of the system, even though its ultimate use is in assisting human operators in a radiotherapy setting. The "Beam-off signal" in response to movement is an automated system response, indicating standalone algorithmic functioning.

7. Type of Ground Truth Used

The ground truth for the performance tests appears to be:

• Physical Phantoms: An "in-house phantom" for surface monitoring accuracy and "phantom treatment" for workflow and accuracy.
• Established Reference System Performance: Comparison to the "previous, well-established Radiation Isocenter Calibration in ETD 1.1."
• Industry Guidelines: Reference to "quality assurance guidelines for non-radiographic radiotherapy localization and positioning systems, that were defined by AAPM Task Group 1472."
• Expected System Behavior: Verification of expected responses (e.g., "Beam-off signal") to phantom movement.

8. Sample Size for the Training Set

This information is not provided in the document. The 510(k) summary focuses on verification and validation testing, not the development or training of specific algorithms that would require a "training set" in the context of machine learning.

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

As no training set is mentioned (see point 8), this information is not applicable/provided.

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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.

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The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.

The Exablate 2100 / 2100V1 Type 3.0 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing an endorectal probe transducer.

The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging ("MRI") in a closed- loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time.

The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5T and 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance and procedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real- time monitoring to achieve safe and effective outcomes.

The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device.

The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position.

The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.

This document appears to be a 510(k) summary for the Insightec Exablate Prostate System. It does not describe a clinical study for software performance and instead focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested items related to a clinical study on device performance, particularly for AI/algorithm performance, are not applicable or cannot be found in this document.

Here's a breakdown based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific performance acceptance criteria for an AI or algorithm, nor does it list reported device performance in those terms. Instead, it states that non-clinical studies demonstrated the device "meets the acceptance criteria and is adequate for its intended use" for various engineering and safety aspects.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a test set or data provenance for an AI/algorithm performance study. The studies mentioned are non-clinical (e.g., system level testing, usability testing).

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

Not applicable. There is no mention of a test set with ground truth established by experts as this is not a study evaluating human or AI performance.

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

Not applicable.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The Exablate Prostate System did not require clinical study because substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing."

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

Not applicable. The document describes the Exablate Prostate System as a high-intensity MR-guided focused ultrasound (MRgFUS) system for prostate tissue ablation, not a standalone AI algorithm. It mentions "Software verification and validation testing were performed", but this is software engineering testing, not standalone AI performance evaluation.

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

Not applicable, as no algorithm performance study with ground truth is described. For the non-clinical studies (e.g., system level, electrical safety, EMC), the "ground truth" would be the engineering and safety standards themselves.

8. The sample size for the training set

Not applicable, as no AI model training is described.

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

Not applicable.

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The Vantage® Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage® Total Ankle System is indicated for cemented use only.

The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:

• 3D Tibial Plates
• 3D+ Tibial Plates ●
• 3D/3D+ Locking Clips ●

The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.

The provided text describes the 510(k) summary for the Exactech® Vantage® Total Ankle System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested details, such as those pertaining to a multi-reader multi-case (MRMC) study, human reader improvement with AI assistance, standalone algorithm performance, or the sample size and ground truth establishment for training and test sets of an AI/ML device, are not applicable to this 510(k) submission.

This submission is for a traditional medical device (total ankle system implants and components), not an AI/ML-driven diagnostic or prognostic device that would typically involve the types of studies described in the prompt. The "acceptance criteria" here refer to the demonstration of substantial equivalence through non-clinical performance testing of mechanical properties and material characteristics, rather than diagnostic accuracy metrics.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a traditional medical device like this are primarily based on established ASTM standards and demonstrating mechanical equivalence to a predicate device. The performance is shown through passing these tests, rather than providing specific numerical thresholds for diagnostic accuracy.

2. Sample size used for the test set and the data provenance

• Not Applicable: This is not a study involving a "test set" of clinical data or images for an AI/ML algorithm. The "testing" refers to mechanical and material performance testing of the device components themselves.

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

• Not Applicable: "Ground truth" in this context refers to the defined mechanical and material properties as per ASTM standards, not expert medical opinion on clinical cases.

4. Adjudication method for the test set

• Not Applicable: No adjudication method for a test set of clinical data is described. The "adjudication" would be related to the interpretation and validation of engineering test results, which is part of standard test protocols.

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: This is a mechanical implant device, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not applicable.

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

• No: This is a mechanical implant device, not a standalone AI algorithm.

7. The type of ground truth used

• For mechanical and material testing, the "ground truth" is based on established engineering principles and recognized consensus standards (e.g., ASTM F2665, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1160, ASTM F1854). These standards define the parameters and methodologies for evaluating the device's performance characteristics.

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set of data.

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

• Not Applicable: As above, this is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical engineering and material characterization tests designed to demonstrate the substantial equivalence of the Exactech® Vantage® Total Ankle System to a legally marketed predicate device (K152217).

• Objective: To show that the proposed new components (3D Tibial Plates, 3D+ Tibial Plates, and 3D/3D+ Locking Clips) have comparable safety and effectiveness to the predicate device, despite minor design and manufacturing differences (e.g., additive manufacturing, additional sizes).
• Methodology: A battery of tests was performed on the device components, adhering to recognized ASTM standards for total ankle replacement devices. These tests evaluated:
  • Fatigue strength of tibial plates and locking mechanisms.
  • Fixation stability of tibial plates.
  • Characteristics of porous surfaces (stereological evaluation, shear, tension, abrasion resistance, compression).
  • Residual particulate count.
  • Pyrogenicity.
• Conclusion: The tests concluded that the strength of the new components is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The pyrogenicity test demonstrated endotoxin levels below the specified limit (< 20 EU/device).

In essence, the "acceptance criteria" for this device are the successful completion of these non-clinical tests, demonstrating that the device components meet the necessary mechanical, material, and safety requirements to perform as intended and are comparable to existing, cleared devices on the market.

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The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.

The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.

The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.

This 510(k) summary describes a medical device, the Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws, and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria and a study proving device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

This document is for a physical orthopedic implant (plate and screw system for bone fixation), not an AI or software device. The "performance criteria" and "testing" described are for mechanical and biocompatibility aspects of the physical hardware, not for diagnostic accuracy, sensitivity, specificity, or other performance metrics usually associated with AI/SaMD.

Therefore, I cannot provide the requested information in the format specific to AI/SaMD for this document. The concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not applicable to the information provided in this 510(k) summary for a physical orthopedic device.

If you have a document related to an AI/SaMD, I would be happy to analyze it for the requested information.

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The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.

• The cemented primary humeral stem, longrevision stems, and all Equinoxe glenoids are intended for cemented fixation.
• The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the surgeon.
• . The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
• . Humeral Heads are intended for use in cemented and press-fit applications.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

The Equinoxe Reverse Shoulder System is in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe Platform Fracture Stem is in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

The proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

This document is a 510(k) summary for medical device clearance, not a study report. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.

Therefore, many of the requested fields cannot be populated from the provided text because they pertain to a type of performance study (e.g., AI algorithm performance, human-in-the-loop studies, ground truth establishment) that is not included in this regulatory submission for a physical orthopedic implant.

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

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

This information is not explicitly provided in the format of acceptance criteria and reported performance metrics in the context of device function (e.g., accuracy, sensitivity, specificity). Instead, the document lists various non-clinical testing performed and states that the proposed device conforms to "the same recognized performance standards" as the predicate devices. This implies that the acceptance criteria are adherence to these standards, and the reported performance is simply that the device passed these tests.

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

• Sample size for test set: Not applicable in the context of this document. The "tests" are non-clinical, mechanical, and biological evaluations, not a test set for an algorithm. The non-clinical testing likely involved a certain number of physical device samples for each test, but those numbers are not specified here.
• Data provenance: Not applicable. The "data" pertains to the results of biomechanical and material tests, not clinical patient data.

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

• Not applicable as this is a physical device clearance, not an AI or diagnostic device requiring ground truth established by experts for a test set.

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

• Not applicable for the same reason as above.

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:

• Not applicable. This is not an AI device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. For a physical orthopedic implant, "ground truth" generally refers to physical measurements, material properties, and biomechanical responses validated against established engineering and medical standards, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

• Not applicable. The device is a physical implant, not an AI model requiring a training set.

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

• Not applicable.

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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.

The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.

This document is a 510(k) premarket notification for a medical device called the Exactech® Alteon® Short Tapered Wedge femoral stem. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a study involving human or AI performance.

Therefore, the requested information about acceptance criteria, study design for device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not available in this document.

This notice details:

• Device Name: Exactech® Alteon® Short Tapered Wedge
• Purpose: Femoral Stem Hip Prosthesis, used in total or hemi hip arthroplasty.
• Indicated Use: For skeletally mature individuals undergoing primary surgery for hip replacement due to various conditions (osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems, proximal femoral fractures) and potentially for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions, and to restore mobility from previous fusion.
• Substantial Equivalence Claim: The device claims substantial equivalence to the Exactech Alteon Tapered Wedge Femoral Stem (K140674) based on similar indications for use, materials, performance requirements (conforming to recognized standards), manufacturing, sterilization, and design features.
• Non-Clinical Testing: The document lists various non-clinical engineering and mechanical tests performed to demonstrate performance (e.g., Distally Fixed Fatigue testing, Femoral Neck Proximal Fatigue testing, Femoral Head Modular junction burst testing, Coating characterization, Range of Motion analysis, Template Studies, Cadaveric Evaluation), but these are not "studies" in the context of clinical performance or AI/human reader performance as implied by the user's request.

In summary, this document is a regulatory submission for a physical medical device (femoral stem), not a software or AI-driven diagnostic device that would typically involve the requested performance study elements.

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