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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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The Exactech® Equinoxe® Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The proposed Equinoxe® Reverse Shoulder System +15mm Humeral Adapter Tray is a modification to the existing Equinoxe® Reverse Shoulder System humeral adapter tray devices previously cleared in K063569. The +15mm humeral adapter tray mates with previously cleared Equinoxe primary press-fit, primary cemented, and cemented revision/long humeral stems (042021) and the Equinoxe reverse shoulder components (K063569). The rationale for the device line extension is to offer an additional size of offset to tension the deltoid and provide stability.

I am sorry, but I cannot provide the requested information because the provided text describes a medical device clearance (a 510(k) submission) for a physical medical device (shoulder prosthesis), not an AI/software device.

The questions you've asked, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are specific to the evaluation of AI algorithms or software as a medical device (SaMD). These types of studies are not typically performed for the clearance of a mechanical orthopedic implant like the Exactech® Equinoxe® Reverse Shoulder System.

The document discusses the substantial equivalence of a new humeral adapter tray to a previously cleared device based on engineering studies and material properties, not on AI performance metrics or clinical ground truth derived from expert readers.

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

The Equinoxe™ fracture adapter tray connects to the Equinoxe™ fracture humeral stems via a morse taper and a non-breakaway locking screw using a 5/16-18 thread instead of the primary adapter tray connecting to the primary/revision humeral stems via a spherical taper and a breakaway locking screw using a M6 thread

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe Reverse Shoulder Fracture Humeral Adapter Tray and Fracture Humeral Adapter Tray Locking Screw. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it describes an engineering evaluation conducted to verify the device's performance. The acceptance criteria and "reported device performance" would typically be found within the detailed engineering evaluation report, which is not fully provided here.

However, based on the provided text, I can infer some aspects and highlight what is missing from the request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text for the requested items):

The provided text is a summary of a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with human subjects, or a standalone algorithm-only performance study. Therefore, most of the requested information for AI/imaging device studies is not applicable or not present in this type of document.

Below is a breakdown of why each point is missing or not applicable in this context:

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

• Not Applicable / Not Provided: This device is a mechanical implant (shoulder prosthesis components), not an AI algorithm or a diagnostic imaging device. The "test set" for this type of device typically refers to samples or prototypes used in mechanical engineering evaluations (e.g., fatigue testing, tensile testing) rather than a dataset of patient images or clinical outcomes. The document refers to "engineering evaluations" but does not specify the number of samples tested or their provenance.

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)

• Not Applicable / Not Provided: Ground truth, in the context of expert consensus, is typically established for diagnostic devices or AI algorithms where interpretation of data (e.g., images) by human experts is key. For mechanical implants, "ground truth" relates to physical properties and performance measured against engineering standards, not expert interpretation. The "experts" involved would be engineering and materials specialists designing and testing the device, and potentially orthopedic surgeons providing clinical input on requirements, but not in the sense of adjudicating a "test set" as described in the request.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., radiologists' readings). This is not relevant for the engineering evaluation of a mechanical implant.

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: MRMC studies are specific to diagnostic devices, particularly in imaging, to evaluate the performance of human readers, sometimes with AI assistance. This is a mechanical implant; therefore, an MRMC study is 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 implant, not an algorithm.

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

• Engineering Standards / Biomechanical Principles: For this type of device, the "ground truth" for performance would be based on established engineering standards (e.g., ISO or ASTM for orthopaedic implants), biomechanical principles derived from cadaveric studies or in-silico models, and clinical requirements for long-term implant function and durability. The summary states "Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use." This implies performance was measured against such standards.

8. The sample size for the training set

• Not Applicable: As this is a mechanical implant and not an AI algorithm, there is no "training set" in the conventional sense of machine learning. The design and development of the device would involve iterative design, prototyping, and testing (the "engineering evaluations"), but not a data-driven training process.

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

• Not Applicable: Since there is no training set, this question is not applicable. The design "ground truth" would be established through clinical need assessment, biomechanical analysis, material science principles, and existing predicate device performance.

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The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

The Equinoxe™ Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.

The Exactech Equinoxe™ Reverse Shoulder System is a medical device for total shoulder joint replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and a detailed study report with performance metrics for this particular device.

However, based on the information provided in the "Summary of Non-Clinical Performance Data," we can infer the types of tests conducted and what would typically serve as acceptance criteria for such a device, even if explicit numerical targets are not stated. The study focuses on mechanical testing and engineering analyses to ensure safety and effectiveness.

Here's an attempt to structure the information based on your request, with the caveat that explicit numerical acceptance criteria and a direct "performance vs. acceptance criteria" table are not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Dynamic Loading Study:
  • Polyurethane bone substitute (TR-2006-052): Sample size for this part is not specified but it involved a "polyurethane bone substitute."
  • Cadaver (TS-2006-024): Sample size not specified, but involved "a cadaver."
• Geometric Analysis Studies (TR-2006-028, TR-2006-029) and Finite Element Analysis (TR-2006-039): These are analytical studies, not involving a "test set" in the sense of patient data or traditional biological samples. They are based on computer models and existing design principles.
• Data Provenance: The studies are non-clinical (mechanical tests, engineering analyses, simulated surgical implantations) and were conducted by Exactech, Inc. The provenance of the specific materials (e.g., cadavers) is not detailed.

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

This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies requiring human adjudication of results.

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

This section is not applicable. This submission is for a physical medical device (reverse shoulder system), not an AI/imaging device, and therefore, no MRMC study or AI assistance evaluation was performed or required.

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

This section is not applicable. This submission is for a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

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

For the non-clinical studies:

• Dynamic Loading and Micromotion: The "ground truth" for comparison appears to be the performance of "Depuy Delta III and Encore RSP components when subjected to a similar loading pattern" (predicate devices).
• Glenosphere Center of Rotation: The "ground truth" for comparison is the "low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder" and the design characteristics of the Delta III.
• Geometric Analyses: "Ground truth" is based on established relationships between prosthetic design parameters and clinical failure modes, as described in literature and previous studies (e.g., Grammont Reverse Shoulder Prosthesis).
• Finite Element Analysis: "Ground truth" is derived from engineering principles and material science, demonstrating that the geometry is not subject to fracture under theoretical worst-case loads.

8. The sample size for the training set

This section is not applicable as this is a physical medical device. The "training" for the design often comes from iterative design processes, engineering calculations, and understanding of biomechanics and clinical outcomes of existing devices, rather than a quantifiable "training set" in the context of machine learning.

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

This section is not applicable as this is a physical medical device. The 'ground truth' for the design process would be established through a combination of:

• Literature review: Understanding biomechanics, materials science, and clinical performance of existing devices.
• Clinical experience: Insights from surgeons and observations of prior device performance.
• Engineering principles: Application of mechanical and material science principles to design and validate components.
• Predicate device analysis: Studying the design and performance of legally marketed predicate devices to understand successful characteristics and potential areas for improvement.

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