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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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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
The cemented primary humeral stem, long/revision stem, fracture 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 discretion 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:
Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
Congenital abnormalities in the skeletally mature
Primary and secondary necrosis of the humeral head.
Humeral head fracture with displacement of the tuberosities
Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
Displaced three-part and four-part upper humeral fractures
Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
Revision of failed previous reconstructions when distal anchorage is required
To restore mobility from previous procedures (e.g. previous fusion)
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 Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), 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 proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

This submission proposes an increase in the angled surface from 12° to 16°, relative to the 12° posterior augment pegged glenoid devices previously cleared via 510(k) K111379. The proposed Exactech Equinoxe Posterior Augment Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, #K103419, and #K111379.

The provided text describes a Special 510(k) for the Exactech® Equinoxe® UHMWPE 16° Posterior Augment Pegged Glenoids™, which is a modification of a previously cleared device (Exactech Equinoxe UHMWPE 12 Degree Posterior Augment Pegged Glenoid, K111379). The primary change is an increase in the angled surface from 12° to 16°.

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

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 the sample size (number of devices or tests) used for the mechanical testing.
The data provenance is from non-clinical performance data (laboratory testing) conducted by the manufacturer, Exactech Inc. It is not patient data (retrospective or prospective) and thus has no country of origin in the clinical sense.

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

This information is not applicable as the study described is a non-clinical, mechanical testing study, not a clinical study involving expert interpretation of patient data.

4. Adjudication Method for the Test Set

This information is not applicable as there was no expert review or adjudication of clinical data. The study was mechanical testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This was a non-clinical mechanical testing study to demonstrate substantial equivalence of a modified medical device.

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

This information is not applicable as the device is a physical implant, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant.

7. Type of Ground Truth Used

The "ground truth" for this study was established through recognized industry standard test methods (ASTM F2028) for evaluating the mechanical properties of glenoid components. This standard defines the criteria for what constitutes acceptable mechanical behavior.

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set" or ground truth established for one.

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The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
The cemented primary humeral stem, long/revision stem, fracture 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 discretion 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:
Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
Congenital abnormalities in the skeletally mature
Primary and secondary necrosis of the humeral head.
Humeral head fracture with displacement of the tuberosities
Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
Displaced three-part and four-part upper humeral fractures
Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
Revision of failed previous reconstructions when distal anchorage is required
To restore mobility from previous procedures (e.g. previous fusion)
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 Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), 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 proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

This submission proposes an increase in the angled surface from 8° to 12°, relative to the 8º posterior augment pegged glenoid devices previously cleared via 510(k) K103419. The proposed Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, and #K103419.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™, structured according to your request.

Please note: This device is a physical medical implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of your requested points regarding AI-specific studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission. The "study" described is a mechanical test to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples of the actual device component.
• Data Provenance: The study was a non-clinical mechanical test, not reliant on patient data.

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

• Not Applicable. This is a mechanical test of a physical device, not an evaluation requiring expert interpretation of clinical data or images. The "ground truth" is defined by the objective standards and measurements within the ASTM F2028 test method.

4. Adjudication Method for the Test Set

• Not Applicable. As a mechanical test, there is no adjudication of subjective expert opinions. Pass/fail criteria are based on objective measurements against the ASTM standard.

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 physical medical device, not an AI/SaMD. MRMC studies are not relevant.

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

• No. This is a physical medical device, not an AI/SaMD. Standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Mechanical Performance Standards: The "ground truth" for this device's performance is adherence to the objective measurements and pass/fail criteria established by the ASTM F2028 standard for glenoid loosening or disassociation.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set."

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

• Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" or corresponding ground truth establishment process in this context.

Summary of the Study for this Device:

The study conducted for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ was a non-clinical mechanical test performed according to ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.

The purpose of this study was to demonstrate substantial equivalence to a previously cleared predicate device (Exactech Equinoxe UHMWPE 8 Degree Posterior Augment Pegged Glenoid, K103419). The primary change in the new device was an increase in the angled surface from 8° to 12°.

The acceptance criteria were that the new device's mechanical performance, specifically regarding glenoid loosening or disassociation, would meet the requirements of the ASTM F2028 standard and be comparable to the predicate device. The document explicitly states: "Test result and analyses provided in this 510(k) demonstrate Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are substantially equivalent to the cited predicate device." This statement confirms that the device met its acceptance criteria based on the results of the mechanical testing.

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