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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.

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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 Equinoxe Reverse Shoulder System is indicated for use 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 proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.

This document describes a Special 510(k) submission for modifications to the Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a change in sterilization method.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Preamble Information:

The document is a letter from the FDA regarding a K162325 submission for Exactech Inc. for the devices mentioned. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set in the traditional sense of a clinical or imaging study. The "testing" primarily refers to bench testing related to the new sterilization method.

The data provenance is for engineering studies and pyrogen testing which focus on materials, design, and sterilization. There's no indication of human or animal data being used for this particular submission's testing. The devices are orthopedic implants, and the context of the submission is a modification to a previously cleared device.

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

This information is not provided in the document. The studies referenced are engineering and pyrogenicity tests, which typically rely on standardized protocols and laboratory analysis rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the engineering and pyrogenicity testing described.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on a modification to an existing device (change in sterilization method), and the testing described is limited to demonstrating the safety and effectiveness of this specific modification through engineering studies and pyrogen testing.

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

This question is not applicable as the device is a physical orthopedic implant (reverse shoulder system components) and not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering specifications and standards: For material properties, dimensions, design features, and device compatibility, ensuring they remain the same as the predicate.
• Standardized testing protocols: For cleaning, sterilization effectiveness, and pyrogenicity (e.g., USP , USP , ANSI/AAMI ST72). The "ground truth" here is compliance with these predefined standards and the associated recommended limits.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that would have a training set. The "training" for this device would refer to the historical data and experience with the predicate devices, which are already marketed.

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

This information is not applicable for the same reasons as point 8.

In summary:

The provided document describes a Special 510(k) where the primary "study" proving the device meets acceptance criteria revolves around demonstrating that a change in sterilization method (from gamma radiation to steam sterilization) for components of an already cleared reverse shoulder system does not alter the fundamental characteristics, performance, safety, or effectiveness of the device. The acceptance criteria are met by proving that the modified components maintain the same indications for use, intended use, materials, design, dimensions, and compatibility as their predicate versions, and that the new sterilization method is effective and meets pyrogenicity standards through engineering and laboratory testing. This is a technical (bench) evaluation, not a clinical study involving human subjects, experts for ground truth, or statistical sample sizes in the context of clinical outcomes.

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The Equinoxe Reverse Shoulder System is indicated for use 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 proposed Equinoxe Reverse Shoulder System 36mm Glenosphere is a modification to the existing Equinoxe Reverse Shoulder System glenospheres previously cleared in K063569. The 36mm Glenosphere mates with previously cleared Equinoxe Reverse Shoulder glenoid baseplate and the glenosphere locking screw (K063569). The rationale for the modification of the devices is to offer a smaller glenosphere for patients in whom the 38mm glenosphere is too large. The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the glenosphere to 36mm, as well as the removal of the extractor cavities on the side of the glenosphere due to size limitations.

The proposed Equinoxe Reverse Shoulder System 36mm Humeral Liners are a modification to the existing Equinoxe Reverse Shoulder System humeral liners previously cleared in K063569. The 36mm Humeral Liners mate with previously cleared Equinoxe Reverse Shoulder humeral tray (K063569). The rationale for the modification of the devices is to offer a smaller humeral liner for patients in whom the 38mm humeral liner is too large. The only modifications to the predicate devices consist of a proposed dimensional change to decrease the radius of curvature on the articulating surfaces of the humeral liners to 36mm.

This document is a 510(k) Summary of Safety and Effectiveness for the Exactech® Equinoxe® Reverse Shoulder System 36mm Glenosphere and Humeral Liners. It demonstrates substantial equivalence to a previously cleared predicate device rather than presenting a standalone study with acceptance criteria for a new device. Therefore, much of the requested information regarding acceptance criteria, human reader studies, and training set details are not applicable in this context.

However, I can extract information related to the non-clinical performance data and the conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a modification (dimensional change) to an existing device, the "acceptance criteria" are not framed as a specific set of target performance metrics but rather as demonstrating that the modified device performs comparably to the predicate device and meets established engineering standards. The reported device performance is presented as the findings from the non-clinical tests.

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

• Sample Size for Test Set: Not explicitly stated in terms of patient data or clinical images. The testing involved:
  • One 36mm Equinoxe Glenosphere for Finite Element Analysis.
  • Unspecified number of 36mm glenospheres and liners for the dynamic loading study.
  • Unspecified number of 36mm glenospheres and liners for geometric analysis.
  • Unspecified number of 36mm glenospheres and liners for polyurethane bone substitute validation.
• Data Provenance: The data is from non-clinical tests (Finite Element Analysis, dynamic loading study, geometric analysis, polyurethane bone substitute validation) conducted by the manufacturer, Exactech, Inc. It is not clinical data from patients.

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

Not applicable. Ground truth, in this context, would typically refer to clinical diagnoses or outcomes. This submission focuses on engineering analysis and mechanical testing, which rely on established engineering principles and measurements, not expert clinical consensus for a "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication of findings by human readers.

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 device is a shoulder prosthesis, not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on:

• Engineering principles and calculations (e.g., ASTM yield strength for FEA).
• Physical measurements and observations from mechanical and simulation studies (e.g., performance of devices in dynamic loading, proper articulation in bone substitute).
• Geometric analysis against the known dimensions and performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and the submission does not describe a machine learning algorithm or a "training set" in that context. The design and testing are based on engineering principles and previous device performance.

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

Not applicable, as there is no training set for a machine learning algorithm involved.

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