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In Anatomic:
The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural dlenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative ioint disease
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

• · Non-inflammatory degenerative joint disease
• · Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:
The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease
• · Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• · Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Stemless Humeral Prosthesis subject to this submission is a humeral anchor intended for press-fit fixation as part of an implant construct in anatomic total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

This FDA submission (K240716) for the AETOS Shoulder System Stemless Humeral Prosthesis does not describe an AI/ML medical device. Therefore, it does not include information on acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies that are typically associated with the evaluation of AI/ML software.

The submission focuses on the substantial equivalence of a new medical implant (a stemless humeral prosthesis) to previously cleared predicate devices. The evaluation criteria for this type of device are primarily based on non-clinical performance data, such as:

• Construct fatigue and corrosion resistance assessment
• Post-fatigue stability
• Static disengagement
• Dynamic stability / loosening
• Bone volume and contact analysis

The document explicitly states: "Clinical performance data were not necessary to demonstrate substantial equivalence of the subject device." This confirms that a clinical study, which would typically involve human readers or an AI algorithm, was not conducted or required for this submission.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because this submission is for a physical orthopedic implant and does not involve AI/ML.

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