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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(K) SUMMARY

Manufacturer:	implantcast GmbHLüneburger Schanze 2621614 BuxtehudeGermany
Contact:	Ms. Juliane HöppnerHead of Regulatory Affairsimplantcast GmbHLüneburger Schanze 2621614 BuxtehudeGermanyPhone: +49 4161 744 135Fax: +49 4161 744 200Email: j.hoeppner@implantcast.de
Prepared By:	Mr. Dave McGurlMCRA, LLC803 7th Street NW, Floor 3Washington, DC 20001Phone: 202.552.5797dmcgurl@mcra.com
Date Prepared:	August 17, 2022
Device Trade Name:	AGILON XO Shoulder System
Device Class andCommon Name:	Class II
Classification:	21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,Metal/Polymer Cemented
Product Codes:	KWT, PHX, HSD
Indications for Use:	The AGILON® XO Shoulder Replacement Systemis indicated for use for total or hemi shoulder replacementin cases of:

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

Device Description: 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

{3}------------------------------------------------

implantcast shoulder components to make a complete prosthesis.

Predicate Device:	- Fx Solutions Humeris Shoulder (K163669)
Reference Device:	- AGILON XO Shoulder Replacement System (K191433)
SubstantialEquivalence:	The AGILON XO Shoulder System AGILON® XO GlenoidCemented components are substantially equivalent to theglenoids of the legally marketed predicate device system, theFx Solutions Humeris Shoulder, with respect to design andintended use. Additionally, the AGILON XO GlenoidsCemented components are substantially equivalent tocomponents of the AGILON XO Shoulder ReplacementSystem reference device cleared in K191433.
Performance Testing:	All necessary testing has been performed for the "worst-case"components of the AGILON XO Shoulder System to assuresubstantial equivalence to its predicate and to demonstrate the

subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:

. Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
. Range of Motion (ROM) Evaluation
The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.

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Indications for Use

510(k) Number (if known) K222482

Device Name AGILON XO Shoulder System

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.

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

{5}------------------------------------------------

· 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Manufacturer:	implantcast GmbHLüneburger Schanze 2621614 BuxtehudeGermany
Contact:	Ms. Juliane HöppnerHead of Regulatory Affairsimplantcast GmbHLüneburger Schanze 2621614 BuxtehudeGermanyPhone: +49 4161 744 135Fax: +49 4161 744 200Email: j.hoeppner@implantcast.de
Prepared By:	Mr. Dave McGurlMCRA, LLC803 7th Street NW, Floor 3Washington, DC 20001Phone: 202.552.5797dmcgurl@mcra.com
Date Prepared:	August 17, 2022
Device Trade Name:	AGILON XO Shoulder System
Device Class andCommon Name:Classification:	Class II21 CFR 888.3650: Prothesis, Shoulder, Non-Constrained,Metal/Polymer Cemented
Product Codes:	KWT, PHX, HSD
Indications for Use:	The AGILON® XO Shoulder Replacement Systemis indicated for use for total or hemi shoulder replacementin cases of:

{7}------------------------------------------------

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.

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

{8}------------------------------------------------

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 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.

Device Description: 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

{9}------------------------------------------------

implantcast shoulder components to make a complete prosthesis.

Predicate Device:	Fx Solutions Humeris Shoulder (K163669)
Reference Device:	AGILON XO Shoulder Replacement System (K191433)
SubstantialEquivalence:	The AGILON XO Shoulder System AGILON® XO GlenoidCemented components are substantially equivalent to theglenoids of the legally marketed predicate device system, theFx Solutions Humeris Shoulder, with respect to design andintended use. Additionally, the AGILON XO GlenoidsCemented components are substantially equivalent tocomponents of the AGILON XO Shoulder ReplacementSystem reference device cleared in K191433.
Performance Testing:	All necessary testing has been performed for the "worst-case”components of the AGILON XO Shoulder System to assuresubstantial equivalence to its predicate and to demonstrate the

. Dynamic Evaluation of Glenoid Loosening or Disassociation (ASTM F2028-17)
. Range of Motion (ROM) Evaluation
The AGILON XO Shoulder System subject to this submission Conclusions: possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the AGILON XO Shoulder System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the AGILON XO Shoulder System components are substantially equivalent to the predicate device for the intended use.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”