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The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:

1. significant disability in degenerative, rheumatic disease of the glenohumeral joint;
2. avascular necrosis of the humeral head.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.

The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability. The collarless stems allow the humeral head to prevent stem subsidence. The stems have a female Morse-type taper to interface with the modular humeral heads. The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.

The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The glenoid implant is a multi-pegged design intended for cemented fixation only.

The provided text describes a 510(k) premarket notification for a medical device, the Shoulder Innovations Total Shoulder System, and specifically a line extension to add "Augmented Glenoids." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of regulatory submission. The document relies on non-clinical testing and comparison to predicate devices to demonstrate substantial equivalence, not a clinical study with detailed performance metrics against predefined acceptance criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a typical acceptance criteria table with performance results. The document explains that non-clinical testing was performed according to ASTM F2028-17 and cadaver testing, and these tests "demonstrated that the Augmented Glenoids are adequate for their intended use." However, specific numerical acceptance criteria and performance values are not reported.

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

• Test Set Sample Size: Not explicitly stated for the non-clinical tests. For cadaver testing, a sample size is typically provided, but it's absent here.
• Data Provenance: The cadaver testing is generally considered prospective in its data collection for the specific purpose of the study. The location of testing or origin of cadavers is not mentioned.

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

This is not applicable as the document describes non-clinical and cadaveric testing, not a study evaluating human interpretation or diagnosis where expert ground truth would be established.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3.

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 is not applicable. The device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is an orthopedic implant, not an algorithm.

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

For the non-clinical tests (ASTM F2028-17 and cadaver testing), the "ground truth" would be the physical measurements and observations from the tests themselves, demonstrating mechanical properties or performance under simulated conditions. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a clinical study.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI algorithm that requires a training set.

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

This is not applicable for the same reasons as #8.

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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 Resurfacing Humeral Head System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total arthroplasty is determined by the surgeon to be the preferred method of treatment. The Equinoxe Resurfacing Humeral Head System is intended for use in patients with the following conditions where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable.

• Osteoarthritis .
• Avascular Necrosis .
• Rheumatoid Arthritis
• Post-traumatic Arthritis .
• Correction of functional deformity 0
• Fractures of the humeral head 0
  The Equinoxe Resurfacing Humeral Head System is intended for uncemented use only.

The Equinoxe Resurfacing Humeral Head System is intended as a cementless humeral resurfacing system that can be used in hemi- shoulder arthroplasty (where it does not articulate with a glenoid component) or total shoulder arthroplasty (where it articulates with a glenoid component). Implantation of this device involves minimal bone removal. The overall design goal of the Equinoxe Resurfacing Humeral Head System is to provide a bone-preserving option for treating degenerative conditions of the shoulder joint.
The Equinoxe Resurfacing Humeral Head System is a modular system, consisting of an articular humeral head component and a humeral cage component mated together via Morse taper connection to provide stabilization of the implant assembly. The dome shaped resurfacing humeral head component is manufactured from cobalt-28Chromium-6Molybdenum alloy per ASTM F1537 with titanium plasma coating per ASTM F1580 and Hydroxylapatite coating per ASTM F1185 on the non-articulating or bone-contacting surface. Manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) with titanium plasma coating per ASTM F1580, the cylindrical cage component features multiple fins for anti-rotation. The variable sizing options and the modular composition of the Equinoxe Resurfacing Humeral Head System facilitates selection and anatomic reconstruction of the native humeral head.
If utilized in total shoulder arthroplasty procedures, the System is compatible with the following Equinoxe Shoulder Glenoid components: Keeled Glenoids, Pegged Glenoids, Caged Glenoids, and Augmented Glenoids cleared with the following 510(k)s: K042021, K093430, K113309, K103419, K111379, and K121220.
The Equinoxe Resurfacing Humeral Head System is accompanied by a complete instrumentation and trial system to assist the surgeon in the implantation of each component.

The provided document is a 510(k) summary for the Exactech® Equinoxe® Resurfacing Humeral Head System, which is a medical device. It does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of AI. The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of characteristics like indications for use, materials, and design features.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from this document as it pertains to AI/ML device studies.

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