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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• · Non- inflammatory deqenerative joint disease including osteoarthritis and avascular necrosis,
• · Post-traumatic osteoarthritis.
• · Fractures,
• · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• · Multi-fragmental comminuted fractures of the humeral head,
• · 3- and 4-Fragment-fractures of the proximal humerus,
• · Head-splitting fractures,
• · Dislocated head-splitting fractures,
• · Humeral head depression with more than 40% of joint surface depressed,
• · Interlocking chronic dislocation with deep HILL-SACHS lesion,
• · Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• · Posttraumatic humeral head necrosis,
• · Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• · Rotator cuff tear arthropathy,
• · Chronic trauma shoulder,
• · Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:

• · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The qlenoid cementless is intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with options depending upon the size and anatomical needs of each patient. The subject submission is for new cancellous screws for use in a total reverse shoulder replacement with the previously cleared K231657 components:

• Humeral Head Components ●
• Glenoid and Glenosphere Components ●
• Humeral Stems and Stem Extension Pieces
• Metaphyseal Components ●
• Fixation and Cancellous Screws ●

The subject line extension components are intended for use with previously cleared AGILON XO Shoulder System instruments. There are no changes to packaging, sterility, shelf life, or materials subject to this submission.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System, focusing on new cancellous screws. However, it does not include detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt regarding AI/algorithm performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and limited performance testing of the new cancellous screws. Therefore, I cannot provide all the requested information.

Here's what I can extract and infer from the provided text, along with what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

• Driving Torque (ASTM F543)
• Axial Pull-out Strength (ASTM F543) |
  | Predetermined acceptance criteria met (specific numeric criteria not provided) | Testing demonstrated sufficient performance and met predetermined acceptance criteria. |
  | Biocompatibility (per ISO 10993-1) | Evaluation completed per ISO 10993-1. |
  | Cleaning, sterilization, packaging, shelf-life, and endotoxin standards met | Leveraged from the predicate AGILON® XO Shoulder Replacement System (K231657). |

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

• Sample Size: Not specified for the cancellous screw testing (Torsional Properties, Driving Torque, Axial Pull-out Strength).
• Data Provenance: Not specified. The manufacturer is implantcast, GmbH, located in Buxtehude, Germany, but the location where testing was performed is not mentioned. The study is part of a 510(k) submission, generally involving laboratory testing rather than clinical data provenance in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical shoulder replacement system, and the testing described is mechanical performance (e.g., strength, torque) and biocompatibility, not an AI or diagnostic device that requires expert ground truth for interpretation of medical images or conditions.

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

Not applicable. This device is a mechanical shoulder replacement system, not a diagnostic or AI device that requires adjudication of expert interpretations.

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 medical device (shoulder replacement system), not an AI-assisted diagnostic tool. No AI component or human reader study is mentioned.

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

Not applicable. This is a medical device (shoulder replacement system), not a standalone algorithm.

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

For the mechanical testing of the cancellous screws, the "ground truth" is established by adherence to recognized ASTM standards (ASTM F543) and engineering principles. For biocompatibility, the ground truth is adherence to ISO 10993-1. This is not related to clinical outcomes or expert consensus on pathologies for AI model training.

8. The sample size for the training set

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device that requires a training set.

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

Not applicable. This device is a mechanical shoulder replacement system, not an AI/machine learning device.

Summary of what is present:

The document describes the submission of a medical device (AGILON® XO Shoulder Replacement System) for regulatory clearance. The specific focus of this submission (K241944) is the addition of new cancellous screws to an existing system. The performance testing for these screws involved:

• Engineering analysis.
• Characterization per ASTM F543 for torsional properties, driving torque, and axial pull-out strength.
• Biocompatibility evaluation per ISO 10993-1.
• Leveraging existing data for cleaning, sterilization, packaging, shelf-life, and endotoxin from the predicate device (K231657).

The conclusion is that the testing demonstrated "sufficient performance for the intended use" and "met the predetermined acceptance criteria." However, the specific quantitative values for these criteria and the test results are not detailed in the provided text.

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The Shoulder Innovation's InSet Total Shoulder System, when used with the Inset Stem, 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. Fractures of the humeral head
3. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
4. Avascular necrosis of the humeral head
5. Revision where other devices or treatments have failed.

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

The InSet 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 peqged design intended for cemented fixation only.

This document concerns the 510(k) premarket notification for the "InSet Total Shoulder System" and specifically a product line extension to add the "InSet 95 Humeral Stem." This is a medical device approval and not an AI/ML software approval.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly aspects related to AI/ML such as ground truth, expert adjudication, MRMC studies, and training/test set sample sizes, are not applicable to this document.

The document states under "Clinical Testing Summary": "Clinical testing was not necessary to demonstrate substantial equivalence of the InSet Total Shoulder System InSet 95 Humeral Stem to the predicate device." This indicates that the approval was based on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects or an AI/ML model's performance evaluation.

Here's a breakdown of what is relevant from the document in relation to the device's acceptance:

Acceptance Criteria and Device Performance (Based on information provided, specifically for this medical device approval):

Study Details (as per the document):

1. Sample size used for the test set and the data provenance: Not applicable. This was not a data-driven AI/ML study but a medical device submission based on substantial equivalence and non-clinical engineering tests. No "test set" in the context of an AI/ML model's performance on patient data was used.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for patient data is not established for this type of device approval. The "ground truth" relates to engineering specifications and performance against those specifications, which were assessed via non-clinical testing and comparison to predicates.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 not an AI-assisted diagnostic device.
5. 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.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device approval would be established engineering standards, material properties, and performance benchmarks derived from predicate devices and regulatory requirements. For example, mechanical strength is evaluated against established limits or performance of predicate devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the FDA's clearance of a physical medical device (shoulder implant) based on its substantial equivalence to previously cleared devices and non-clinical engineering testing, not on the performance of an AI/ML algorithm or clinical studies involving human patient data.

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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• · Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• · Post-traumatic osteoarthritis,
• · Fractures,
• · Rheumatoid arthritis.

The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:

• · Multifragmental comminuted fractures of the humeral head,
• · 3- and 4-Fragment-fractures of the proximal humerus,
• · Head-splitting fractures,
• · Dislocated head-splitting fractures,
• · Humeral head depression with more than 40% of joint surface depressed,
• · Interlocking chronic dislocation with deep HILL-SACHS lesion,
• Fracture instability following internal fixation attempt in 3-fragment fractures (secondary dislocation, material loosening),
• · Posttraumatic humeral head necrosis,
• · Omarthrosis.

AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty, to treat a patient after an inverse shoulder has failed. It is not combined with a glenoid implant. It can be used in primary and revision cases.

The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:

• · Rotator cuff tear arthropathy,
• · Chronic trauma shoulder,
• · Decentering of the humeral head after implantation of a humeral head prosthesis.

Please note, that the patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary.

In case of revision surgery, the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system, can be performed in revision cases as follows:

• · From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
• · From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• · From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• · From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty

The device is intended for adults.

The AGILON® XO Shoulder Replacement System Titanium alloy stems are intended for cementless fixation.

The PE-glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation. The glenoids cementless are intended for cementless use with the addition of screws for fixation.

The AGILON® XO Shoulder Replacement System is a modular shoulder replacement system offering various components that can be combined to replace the shoulder joint with various options depending upon the size and of each patient. The components can be combined for use in a total (anatomic and reverse) or a hemi shoulder replacement:

Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap)
• Humeral Stems (Cementless)

Total Anatomic Shoulder:

• Humeral Head Components (AGILON® XO Cap)
• Glenoid Components (AGILON® PE-Glenoid, Cemented)
• Humeral Stems (Cementless)

Total Reverse Shoulder:

• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• Glenoid and Glenosphere Components (AGILON® XO Glenoid Baseplate and AGILON® ● Glenosphere)
• Humeral Stems (Cementless)

Metaphyseal components (including a new line extension 145°), stem extension pieces, and component connection fixation screws are intended to be used for hemi and total (anatomic and reverse) shoulder configurations.

The subject system also includes device-specific reusable instruments for use with the subject implants, including an osteotomy guide, implant trials, and a humeral cutting block.

The provided text describes a 510(k) premarket notification for the AGILON® XO Shoulder Replacement System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a novel AI/software component.

Therefore, many of the requested sections regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, or AUC), sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily relies on "Performance Testing Summary" through engineering analyses and leveraging previous predicate device testing to establish substantial equivalence for a line extension (a new 145° Metaphyseal component).

Here's an attempt to answer the questions based on the provided text, indicating when information is not available or not applicable:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria for a novel device performance study, nor does it report specific performance metrics like sensitivity, specificity, or AUC as would be expected for an AI/software device. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering analysis and leveraged testing.

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

Not applicable. This submission concerns a physical medical device (shoulder replacement system) and a line extension, not an AI/software device requiring a test set of data. The "testing" primarily refers to engineering analyses and biocompatibility/sterilization testing, not a clinical data evaluation in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of experts establishing a ground truth for a test set of data, as this is not an AI/software device.

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

Not applicable. No adjudication method is mentioned as there is no human-reviewed test set data in the context of an AI/software device.

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 submission is for a physical shoulder joint replacement system, not an AI/software device designed to assist human readers.

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

Not applicable. This submission is for a physical shoulder joint replacement system, not an AI/software algorithm.

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

Not applicable. There is no mention of ground truth in the context of data for an AI/software device. The "ground truth" for a physical device refers to its physical properties, biocompatibility, and mechanical performance under various conditions, which are addressed through specifications, engineering analyses, and standardized testing (e.g., ISO for biocompatibility).

8. The sample size for the training set

Not applicable. As this is not an AI/software device, there is no training set mentioned in the document.

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

Not applicable. As this is not an AI/software device, there is no training set or associated ground truth establishment mentioned in the document.

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The Comprehensive® Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The provided text describes a medical device, the "Comprehensive Segmental Revision System (SRS)," and its 510(k) premarket notification to the FDA. This document is a regulatory submission for a medical device and thus does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered diagnostic or predictive system.

The text does mention:

• Non-Clinical Tests/Justification: Coating Characterization, Fatigue Strength Report Flanges, Fatigue Strength Analysis Humeral Stems, Shot Peen Testing Summary, and MRI. These are engineering and material science tests relevant to the physical implant's safety and performance, not a study of an AI system's diagnostic accuracy.
• Clinical Tests: "None provided." This explicitly states that no clinical studies were performed for this specific submission to expand the indications of the device, as substantial equivalence was demonstrated through other means (comparison to predicates, engineering tests).

Therefore, based on the provided text, I cannot answer questions 1 through 9 as they relate to the performance evaluation of an AI device. The document is about a mechanical orthopedic implant, not an AI system.

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The AGILON® XO Shoulder Replacement System is indicated for use for total or hemi shoulder replacement in cases of:

• Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
• Post-traumatic osteoarthritis,
• Fractures.
• Rheumatoid arthritis.
  The main indications for the implantation of an AGILON® hemi shoulder prosthesis are:
• . Multifragmental comminuted fractures of the humeral head.
• 3- and 4-Fragment-fractures of the proximal humerus,
• Head-splitting fractures.
• Dislocated head-splitting fractures,
• . Humeral head depression with more than 40% of joint surface depressed,
• Interlocking chronic dislocation with deep HILL-SACHS lesion,
• . Fracture instability following internal fixation attempt in 3-fragment and 4-fragment fractures (secondary dislocation, material loosening),
• Posttraumatic humeral head necrosis,
• . Omarthrosis.
  AGILON® CTA heads are destined for treatment of stable types of rotator cuff tear arthropathy. In order to achieve satisfactory results with the CTA heads the fornix humeri and the subscapularis tendon must be intact. A CTA cap is intended for the use as a hemi-arthroplasty to treat a patient in revision cases after an inverse shoulder has failed. It is not combined with a glenoid implant. It can also be used in primary cases.
  The main indications for the implantation of an AGILON® inverse (reverse) shoulder prosthesis are:
• Rotator cuff tear arthropathy,
• Chronic trauma shoulder,
• Decentering of the humeral head after implantation of a humeral head prosthesis.
  Please note, that the patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary.
  AGILON® retentive caps invers are indicated in case of shoulder joint instability if the joint cannot be stabilized with a regular AGILON® cap inverse in combination with a Glenosphere. Warning: The use of the AGILON® retentive caps invers entails a decrease of the Range of Motion of the prosthesis. The surgeon has to balance conscientiously the advantage of stabilization and the increased risk of scapula impingement.
  In case of revision surgery the available bone stock has to be evaluated to allow for implantation of well-fixed stems. Conversion of the system can be performed in revision cases as follows:
• . From Hemi Shoulder Arthroplasty to Anatomic Total Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Hemi CTA . Shoulder Arthroplasty
• From Hemi Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi Shoulder Arthroplasty as salvage procedure
• . From Inverse (Reverse) Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty as salvage procedure
• From Anatomic Total Shoulder Arthroplasty to Inverse (Reverse) Total Shoulder Arthroplasty
• From Anatomic Total Shoulder Arthroplasty to Hemi CTA Shoulder Arthroplasty
  The surgeon decides which version of prosthesis for the individual patient is used. This decision depends on several factors, such as the age and the patient's weight, bone quality, shape of the bone and deformation of the joint.
  The device is intended for adults.
  The stems of the AGILON® XO Shoulder Replacement System are intended for cementless fixation. The glenoids of the AGILON® XO Shoulder Replacement System are intended for cemented fixation.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the ALIGON® XO Glenoid Cemented components to the AGILON XO Shoulder System. The components are a line extension to the previously cleared AGILON XO Shoulder Replacement System which add all polyethylene cemented glenoids to the current system. The components introduced with this submission are intended to mate with other previously cleared implantcast shoulder components to make a complete prosthesis.

This document describes the AGILON XO Shoulder System, a Class II medical device. The information provided outlines the regulatory submission, specifically a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device.

However, the provided text does not contain the information requested regarding the acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced AI/algorithm-based performance. The context of the request (acceptance criteria, test set, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is typical for the clinical validation of AI/ML-driven medical devices.

The document instead describes performance testing related to the mechanical and physical properties of the shoulder implant components, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text. The "Performance Testing" section explicitly mentions:

• . Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
• . Range of Motion (ROM) Evaluation

These are engineering/mechanical tests to characterize the physical device, not an assessment of an AI algorithm's diagnostic or predictive capabilities.

To answer your prompt, I would need a document that discusses the performance of an AI/ML component of a medical device, including details about its clinical validation study design and results.

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General indications: The LINK Embrace Shoulder System - Anatomic Configuration is intended for anatomic total or hemi shoulder arthroplasty.

Indications:
• A severely painful and/or disabled shoulder joint resulting from osteoarthritis or theumatoid arthritis

• · Avascular necrosis of the humeral head
• · Deformity and/or limited motion
  · Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
  · Revision of a failed primary component
• · Ununited humeral head fractures
• · Cuff tear arthropathy (CTA Heads only)

The All Poly Glenoid Components are intended for cemented use.

The Humeral Stems Standard with CaP (HX) and Short with CaP (HX) are intended for cementless fixation.

The Humeral Stems Standard without CaP (HX) and Short without CaP (HX) are intended for cementless fixation.

The Humeral Fracture Stems are intended for cementless fixation.

The LINK Embrace Shoulder System offers diverse fixation options suitable for the majority of patient populations and indications. A wide range of stems in different configurations allows for cemented and cementless fixation.

Humeral Stems (Ti6Al4V) are available in monoblock designs, and feature a proximal modular taper connection for assembly to head adapters. The monoblock Humeral Stems are available in Standard Stems and Short Stems with a broad size spectrum, and in non-coated and Calcium Phosphate coated versions. Humeral Fracture Stems are also available. The Humeral Stems have been previously cleared for use with the LINK Embrace Shoulder System – Reverse [K200368].

Humeral Heads (CoCrMo) are available in several sizes with a female taper for connection to the Head Adapters.

CTA Heads (CoCrMo) are available in neutral and different offset versions and feature a male taper for connection to Humeral Stems.

The Cemented All Poly Glenoids are available in conventional polyethylene and in highly crosslinked polyethylene with Vitamin E (E-Dur).

The LINK Embrace Shoulder System is supported by a streamlined, lightweight and ergonomic instrument set.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

Important Note: The provided document is an FDA 510(k) clearance letter and a 510(k) Summary for a medical device (LINK Embrace Shoulder System - Anatomical Configuration). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance metrics, ground truth, experts, and reader studies are not applicable to this document, as it describes a physical shoulder implant, not an AI-powered diagnostic or therapeutic tool.

The "acceptance criteria" in this context refer to the successful completion of non-clinical performance tests and analyses to demonstrate the device's safety and effectiveness compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions related to AI/Software Performance:

Since this document describes a physical medical implant (shoulder prosthesis) and not an AI/software device, the following questions are not applicable (N/A). The concept of "test set," "training set," "ground truth experts," and "reader studies for AI" do not apply in this context.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/software device)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Not an AI/software device)
4. Adjudication method for the test set: N/A (Not an AI/software device)
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: N/A (Not an AI/software device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
7. The type of ground truth used: N/A (Not an AI/software device)
8. The sample size for the training set: N/A (Not an AI/software device)
9. How the ground truth for the training set was established: N/A (Not an AI/software device)

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When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

TiN coated Heads are not intended for hemi-shoulder arthroplasty

When used with the Humeris™ Shoulder System: In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

TiN coated Heads are not intended for hemi-shoulder arthroplasty.

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.

This document is a 510(k) Premarket Notification from the FDA regarding a TiN Coated Humeral Head. It does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, training set details) because this document does not pertain to an AI/ML medical device and does not contain information about a study proving an algorithm's performance.

The document states:

• "Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head to the predicate devices." (Page 7)
• The determination is based on the device being "identical to the primary predicate with the only modification of added TiN coating" and a review of "risk analysis, design controls, biocompatibility, wear properties of the TiN coating, and verification and validation activities to demonstrate that the TiN coating does not increase risk and does not raise new questions of safety and effectiveness." (Page 7)

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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 Catalyst CSR Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where hemi- or total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment. The Catalyst CSR Shoulder System is intended for use in patients with the following conditions where the humeral head, neck and glenoid vault 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

The Catalyst CSR humeral and glenoid implants are intended for cemented use.

The Catalyst CSR Press-Fit humeral implants are intended for uncemented or cemented use.

The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.

This submission adds augmented glenoid components to the CSR Shoulder System. The CSR Augmented Glenoids are nearly identical to the previously cleared CSR 3 Peg Glenoids, except that additional material has been added to the fixation surface creating a 10 degree posterior wedge. Like the previously cleared CSR 3 Peg glenoid components, the CSR Augments are manufactured from UHMWPE conforming to ASTM F648. Also like the previously cleared CSR 3 Peg Glenoid components, three sizes of augmented glenoid components are available. The bearing surface has a symmetrical, oval shaped profile allowing use of each component on either the right or the left side. The glenoid component is designed to allow insertion at an angle, in the same orientation as the surgeon's exposure, to reduce the forceful retraction and bone and soft tissue trauma usually required to insert standard glenoid components. Three backside pegs are engineered to provide implant fixation within the dense cortical and subchondral bone.

The CSR Augmented Glenoid components are compatible with previously cleared CSR Press-Fit humeral components.

This document describes a 510(k) premarket notification for the Catalyst OrthoScience CSR Shoulder System, specifically focusing on the addition of augmented glenoid components. This is a medical device submission, and as such, it does not involve the type of AI/ML device performance criteria, studies, or ground truth establishment typically requested in your prompt.

Therefore, many of the requested fields are not applicable to this document. The existing information pertains to the non-clinical testing performed to demonstrate the device's safety and effectiveness for its intended use, rather than a clinical study evaluating diagnostic accuracy or similar AI model performance.

Here's a breakdown based on the provided text, indicating where information is not applicable:

1. A table of acceptance criteria and the reported device performance

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The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned.

The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications: Zimmer® Trabecular Metal™ Reverse Plus Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System and Comprehensive® Reverse Augmented Baseplates.

The Signature™ ONE Guides and bone models are intended for single use only.

The Signature™ ONE System is developed to assist in pre-operative planning of the glenoid component for Total Shoulder Arthroplasty (using the Signature™ ONE Planner) and to accurately transfer a pre-operative plan to orthopedic surgical procedures (using the Signature™ ONE Guides) if desired. Both anatomic and reverse (TSA and RSA respectively) approaches are supported.

The Signature ONE Guides and Bone Model are designed and manufactured of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized pre-surgical plan and shipped prior to surgery. The guides and bone models are provide nonsterile and sterilized at the hospital. They are used intraoperatively to assist the surgeon in reproducing the plan. The Signature ONE System surgical technique remains close to the conventional shoulder arthroplasty to allow converting to standard surgical technique at any time if needed during the operation.

The Signature™ ONE System uses the Zimmer Biomet Drive Portal for the interaction with external users (i.e. imaging technician and the surgeon). The internal users (i.e. the Zimmer Biomet operators) use manufacturing software applications to prepare the patient cases for the surgeon.

The provided text describes the 510(k) premarket notification for the Signature™ ONE System, a device intended to assist in pre-operative planning and intra-operative guiding for shoulder replacement surgery. However, the document does not contain specific acceptance criteria, detailed study results proving device performance against those criteria, or information regarding AI/algorithm performance metrics.

It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation, rather than providing a detailed performance study with quantitative acceptance criteria and results.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, although testing on "cadaveric specimens" is mentioned. The country of origin of the data is not provided. It is presented as nonclinical performance data, and the general nature of such testing typically implies prospective testing on the device model.

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

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text.

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

• MRMC Study: Not mentioned.
• Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as no MRMC study or AI performance improvement claims are detailed. The device is described as assisting in pre-operative planning and intra-operative guiding, not as an AI for reading or interpreting medical images in the context of improving human reader performance.

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

• The document implies a "human-in-the-loop" system where the surgeon reviews, modifies, and approves the plan. It states the system "assist[s] in pre-operative planning and/or intra-operative guiding" and surgeons "interact with to review, modify and approve the plan."
• No standalone algorithm-only performance is detailed.

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

The term "ground truth" is not explicitly used. However, the validation lab performed studies "under full simulated use on cadaveric specimens," implying that the performance was assessed against known anatomical structures and surgical targets within those specimens, likely guided by expert surgical opinion and established anatomical references for accuracy.

8. The sample size for the training set

Not applicable. The document describes a medical device for surgical planning and guidance, not an AI/machine learning algorithm with a distinct "training set."

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

Not applicable. See #8.

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