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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 Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total shoulder arthroplasty are as follows:

• · Osteoarthritis, osteonecrosis or post-traumatic degenerative problems
• · Congenital abnormalities in the skeletally mature
• · Primary and secondary necrosis of the humeral head
• · Pathologies where arthrodesis or re sectional 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)
• · To restore mobility from previous procedures (e.g. previous fusion)

In the USA, the Equinoxe Stemless Shoulder is only indicated for total shoulder arthroplasty.

The Equinoxe Stemless Shoulder humeral components are indicated for press-fit, uncemented use.

When used in total shoulder arthroplasty, the Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.

The Equinoxe Stemless Humeral Components are intended to be used with Exactech Equinoxe Stemless Humeral Heads and the Equinoxe glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V and have porous regions. The Equinoxe Stemless Humeral Components are available in in three sizes, with lengths between 17mm and 24mm.

This FDA 510(k) K192097 premarket notification is for a medical device called the Exactech® Equinoxe® Stemless Humeral Components. It is an orthopedic implant for shoulder arthroplasty.

It's important to note that this document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device through engineering analyses and non-clinical testing. It does not involve studies with human subjects, AI algorithms, or deep learning models. Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone AI performance, training set sample size) are not applicable to this type of device submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail numerical sense for each test. Instead, it states that the devices "perform as intended and are substantially equivalent to the identified predicate devices" based on the non-clinical testing. The "reported device performance" is the conclusion that the device passes these tests, thereby demonstrating substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for fatigue). These would typically be determined by relevant ASTM or ISO standards for testing orthopedic implants, but are not detailed in this summary.
• Data Provenance: Not applicable in the context of this device. The "data" comes from engineering and laboratory testing of the physical device components, not from patient data or clinical images. It's not retrospective or prospective in the clinical sense.

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

Not applicable. "Ground truth" in this context is established by physical measurement against engineering specifications and industry standards for material properties, mechanical performance, and sterilization. It doesn't involve clinical experts establishing diagnoses or observations.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of clinical cases requiring adjudication. The tests are physical and chemical evaluations.

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 a physical orthopedic implant, not an AI-powered diagnostic or assistive device for human readers.

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

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

7. The Type of Ground Truth Used

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

• Established mechanical engineering principles.
• Relevant ASTM/ISO International Standards for orthopedic implants.
• FDA Guidance Documents (e.g., for sterility).
• Material specifications (e.g., for Ti-6Al-4V).
• Functional requirements for shoulder replacement devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is a physical implant, not a machine learning model.

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

Not applicable, as there is no training set.

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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 Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty 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.
• · 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)
• · To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech under the Equinoxe brand name. The subject device is intended to provide surgeons with a short-stem, distal bone preserving option that is compatible with minimally invasive surgical techniques. The proposed device is manufactured from Ti-6Al-4V and has Titanium Plasma Spray, grit blasted, and polished regions. The stems are available in 10 sizes, with distal stem diameters between 6mm and length of 70mm.

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe® Preserve Stem, a humeral stem for shoulder replacement surgery. It establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies in the way you've outlined, as this document pertains to a physical orthopedic implant and its regulatory clearance process based on substantial equivalence, not an AI/software as a medical device.

The document discusses:

• Indications for Use: What the device is intended for.
• Technological Characteristics: How the device is similar to predicate devices (materials, design, dimensions, sterilization).
• Non-Clinical Testing: Engineering analyses performed to demonstrate performance (Fatigue Testing, Subsidence and Pull-out Testing, Pyrogen testing).

It does not contain information about:

1. A table of acceptance criteria and reported device performance (in terms of AI metrics).
2. Sample size for a test set, data provenance, or ground truth.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or therapeutic device that would require the specific types of studies and acceptance criteria you're asking about.

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The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.

The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.

The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.

The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.

The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.

This document appears to be a 510(k) Summary for a medical device called the "Remedy® Shoulder Spacer." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study designed to meet specific acceptance criteria in the way one would for an AI/ML powered device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it describes a physical orthopedic implant, not a software algorithm.

Below is an attempt to map the available information to the closest relevant categories, with explanations for why certain sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, the concept of "acceptance criteria" for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) is not present. Instead, the document discusses performance testing designed to demonstrate safe and effective mechanical function and material properties, and equivalence to a predicate device. The "acceptance criteria" would be compliance with relevant standards and demonstration of properties comparable to the predicate.

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

This is not applicable for a physical device 510(k) submission in the context of diagnostic "test sets." The performance data is based on laboratory testing of the device itself and its components, according to established engineering and material science protocols. There is no biological "data" in the sense of patient images or clinical outcomes that would have "provenance."

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

This is not applicable. "Ground truth" in this context refers to a standard of truth for diagnostic or clinical outcome data, which is not evaluated here. The "truth" for device performance is established through physical and chemical testing against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

This is not applicable. There is no clinical "test set" requiring adjudication by experts.

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 as this is not an AI/ML device or a diagnostic device involving "human readers."

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

This is not applicable as this is not an AI/ML device.

7. The type of ground truth used

This is not applicable in the AI/ML sense. The "ground truth" for the device's acceptable performance is defined by:

• Compliance with recognized standards: e.g., ISO for biocompatibility, sterilization standards.
• Engineering and material science principles: for mechanical strength, fatigue, material composition.
• Comparative data to a legally marketed predicate device: demonstrating that the new device is "substantially equivalent" in terms of safety and effectiveness.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device. There is no concept of a "training set" for a physical orthopedic implant.

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

This is not applicable as this is not an AI/ML device.

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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 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:

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 4part 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 modifying the Exactech Equinoxe Replicator Plates and Fixed Angled Replicator Plates cleared under 510(k) #K042021 and #K102951. The proposed modifications are as follows:

• 1. The proposed replicator plates and the fixed angled replicator plates will attach to the humeral head using a morse taper that is half the height of the morse taper of the anatomic replicator plates and fixed angled replicator plates cleared in 510(k) #K042021 and 510(k) #K102951.
     The proposed Exactech Equinoxe Replicator Plates, and Fixed Angled Replicator Plates are intended to be used with the same Equinoxe Shoulder system components described in 510(k). #K042021 and #K102951 as cited predicates.

This document is a 510(k) premarket notification for a medical device: the Exactech® Equinoxe® Shoulder System Short Replicator Plates.

The document discusses the device's equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving the device meets them through clinical studies in the way a new, high-risk device might. This 510(k) is specifically for modifications to an already cleared device, focusing on "short replicator plates." Therefore, the "study" described is a non-clinical performance data assessment to demonstrate substantial equivalence to predicate devices, rather than a clinical trial to establish efficacy or safety for a novel device.

Given this context, I will address your points to the best of my ability based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are not framed as clinical performance metrics (like sensitivity, specificity, etc.) but rather as successful demonstrations of substantial equivalence in non-clinical tests. The "reported device performance" refers to the results of these non-clinical tests.

2. Sample Size for the Test Set and Data Provenance

The "test set" in this context refers to the samples used in the non-clinical performance data.

• Sample Size: Not explicitly stated. For mechanical tests like "humeral head pull-off," multiple samples would typically be tested, but the exact number is not provided in this summary. For "cadaveric validation," the number of cadavers used is not specified.
• Data Provenance: Not explicitly stated, but these are engineering/biocompatibility tests conducted by the manufacturer (Exactech, Inc.) likely in a lab setting. It is not patient data from a specific country, retrospective, or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission (510(k) for device modification based on substantial equivalence) does not involve expert review panels to establish "ground truth" in terms of clinical outcomes or diagnoses. The "ground truth" for the non-clinical tests would be the specifications and requirements of the ASTM standard (for mechanical testing) and the functional success of the device in cadaveric validation, evaluated by engineers and biomechanical experts involved in the device's development and testing. No specific number or qualifications of "experts" are noted in this summary with regard to establishing ground truth for testing.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human readers or diagnoses that would require an adjudication method like 2+1 or 3+1. The tests are engineering and biomechanical assessments against established standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study designed to evaluate how human readers' performance (e.g., in diagnosis) changes with and without AI assistance across multiple cases. This document describes a 510(k) premarket notification for shoulder system components, focusing on non-clinical data for substantial equivalence, not a clinical study of AI-assisted diagnostic effectiveness.

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

No. This document concerns physical medical devices (shoulder implant components), not algorithms or AI software. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests mentioned is:

• Engineering Standards: For the humeral head pull-off test, the "ground truth" is defined by the specific requirements and performance metrics outlined in ASTM F2009-00.
• Functional Success: For the cadaveric validation, the "ground truth" is the successful functional demonstration that the humeral head can be impacted on axis, indicating proper mechanical interaction and fit.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve machine learning or AI, so there is no "training set." The focus is on the physical properties and functional aspects of a modified medical implant.

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

Not applicable, as there is no training set for this type of device submission.

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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.

Ask a specific question about this device

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:

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 modifying Exactech Equinoxe Cage Glenoid devices cleared via 510(k) #K093430 to change peg geometry and add plasma coating. The proposed Equinoxe Cage Glenoids are intended to be used with the same Equinoxe shoulder system components described in 510(k) #K042021 and 510(k) #K061454 as cited predicates.

The provided text describes a Special 510(k) submission for the Exactech Equinoxe® Cage Glenoids™, which proposes modifications to previously cleared devices. The submission focuses on demonstrating substantial equivalence to a predicate device (Exactech Equinoxe Cage Glenoid, K093430) through non-clinical performance data.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the mechanical testing standards and the conclusion of substantial equivalence. The "reported device performance" is a statement that the device met these criteria, rather than specific numerical results.

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

• Sample Size: Not explicitly stated. The document mentions "test results and analyses," which are typically derived from a specific number of samples for each mechanical test, but the exact number of units tested for each criterion is not provided.
• Data Provenance: Not explicitly stated regarding country of origin. The study is a non-clinical performance study (mechanical testing), not a study involving patient data. Therefore, the concepts of "retrospective or prospective" and "country of origin of the data" are not directly applicable in the same way they would be for a clinical study. These are laboratory-based engineering tests.

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

This information is not applicable to this submission. The "ground truth" for non-clinical mechanical testing is established by adherence to recognized industry standards (e.g., ASTM standards) and the physical properties and performance of the device under specific test conditions. Expert opinion is not used to establish the "ground truth" in the same way it would be for a clinical diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving human interpretation or subjective assessments, often in diagnostic imaging. Mechanical testing results are objective measurements against predefined standards.

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 information is not applicable. This submission is for modifications to a glenoid component (a medical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is entirely irrelevant to this device.

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

This information is not applicable. This is a physical medical device (implant), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Adherence to recognized industry standards: Specifically, various ASTM standards for mechanical testing (e.g., F2028, F1160, F1044, F1147, F1978). These standards define the test methods and often acceptable performance ranges for similar devices.
• Comparison to the predicate device: The fundamental "ground truth" for a 510(k) submission, especially a Special 510(k) for modifications, is demonstrating that the modified device performs equivalently to a legally marketed predicate device, as confirmed by comparing design features, materials, dimensions, and mechanical performance under the same test conditions.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of mechanical testing for a medical implant. Training sets are relevant for machine learning algorithms.

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

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

Ask a specific question about this device

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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