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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.

Ask a specific question about this device

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.

Ask a specific question about this device

The AGILON® XO Shoulder Replacement System is indicated for use for cementless inverse (reverse) 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.

AGLON® 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 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

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 into an hemi or reverse shoulder:
Hemi Shoulder:

• Humeral Head Components (AGILON® XO Cap and AGILON® XO CTA Cap) ●
• o Humeral Stems (Cementless)
  Reverse Shoulder:
• Humeral Head Components (AGILON® Cap Inverse and AGILON® PE-Inlay) ●
• o Glenoid and Glenosphere Components (AGLION® XO Glenoid Baseplate and AGILON® Glenosphere)
• o Humeral Stems (Cementless)
  Metaphyseal components, stem extension pieces, and component connection fixation screws are intended to be used for hemi and reverse shoulder configurations.

This document describes the AGILON® XO Shoulder Replacement System, a modular shoulder replacement system. However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML-driven medical devices.

Instead, this document is a 510(k) premarket notification summary for a traditional medical device (shoulder replacement system) and focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance testing" section refers to mechanical and material property testing, which is standard for orthopedic implants, not performance studies for an AI/ML algorithm.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance study details for an AI system because that information is not present in the provided text. The document is about a physical implant, not a software device with performance criteria like sensitivity, specificity, or reader improvement.

Ask a specific question about this device