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Indications for AltiVate™ Stem:

Anatomic Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis;
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
• Post-traumatic arthritis of the glenohumeral joint;
• Avascular necrosis of the humeral head with and without involvement of the glenoid;
• Correction of functional deformity ●

The all-poly glenoid is intended for cemented use

Hemi Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis; ●
• Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; ●
• Post-traumatic arthritis of the glenohumeral joint;
• Avascular necrosis of the humeral head with and without involvement of the glenoid;
• Correction of functional deformity;
• Rotator cuff tear arthropathy;
• Humeral fracture.
• Failed previous shoulder surgery

Reverse Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• . Previously failed joint replacement with a grossly deficient rotator cuff;
• . Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• . Bone defect in proximal humerus;
• . Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• Inflammatory arthritis including rheumatoid arthritis;
• Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures

All humeral stems are intended for cemented or cementless use.

The AltiVate™ Reverse Small Shell Shoulder is a line extension to the AltiVate Reverse System. It consists of four primary components: humeral stem, socket insert, spacer and hemi-adaptor. Device specific instrumentation will also be used. Components are offered for either primary or revision surgery applications, in a hemi or total shoulder application.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding a shoulder joint prosthesis (AltiVate Reverse Humeral Stem, etc.).

It primarily discusses:

• The FDA's substantial equivalence determination for the device.
• Regulatory information and requirements for the manufacturer.
• Indications for Use of the device (Anatomic Total Shoulder, Hemi Shoulder, Reverse Total Shoulder).
• Comparison to predicate devices (previously marketed and cleared devices).
• Non-clinical testing (mechanical testing, endotoxin assessment) that determined substantial equivalence.
• A statement that clinical testing was not required.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (as clinical performance criteria are not defined for this 510(k)).
2. Sample size and data provenance for a test set (as no clinical test set was used).
3. Number and qualifications of experts for ground truth (as no clinical ground truth was established by experts).
4. Adjudication method (not applicable).
5. MRMC comparative effectiveness study (not applicable).
6. Standalone algorithm performance (not applicable, as this is a physical medical device, not an AI algorithm).
7. Type of ground truth (not applicable).
8. Sample size for the training set (not applicable, as no training set for an algorithm was used).
9. How ground truth for the training set was established (not applicable).

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