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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

· Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis

• · Rheumatoid and other inflammatory arthritis
• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

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

Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This FDA 510(k) summary is for the AltiVate® Anatomic Shoulder AG e+™ with Markers. It is a premarket notification, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance in the way a clinical trial report would.

However, based on the provided text, I can infer some aspects and directly state where information is not available.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria or reported device performance in the sense of clinical metrics (e.g., pain reduction, range of motion improvement). Instead, it discusses the substantial equivalence to a predicate device based on material, design, and manufacturing standards.

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

• Sample Size for Test Set: Not applicable in the context of the testing performed for this 510(k). The mechanical testing mentioned (ASTM F2028-17) would have a sample size of components, but it is not specified here. There was no clinical study.
• Data Provenance: Not applicable as a clinical test set. The mechanical testing would have been conducted in a lab.

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. No clinical test set with human interpretation requiring ground truth by experts was conducted or needed for this 510(k) submission.

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

Not applicable. No clinical test set requiring adjudication was conducted.

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 device is a shoulder implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a shoulder implant, not an algorithm.

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

Not applicable. The "ground truth" for this device's regulatory clearance is established through demonstrating substantial equivalence to a legally marketed predicate device, primarily through engineering principles, material science, and adherence to relevant ASTM standards for mechanical performance.

8. The sample size for the training set

Not applicable. The device is a mechanical implant; there is no "training set" in the context of machine learning or algorithms.

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

Not applicable. See point 8.

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The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:
• Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis
· Rheumatoid and other inflammatory arthritis

• · Correction of functional deformity, including fracture malunion
• · Humeral head fracture
• · Revision of other devices if sufficient bone stock remains

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

Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

This document is a 510(k) summary for a medical device (AltiVate® Anatomic Shoulder AG e+™ with Markers), not a study report demonstrating device performance against specific acceptance criteria for AI/ML. Therefore, the information required to answer your specific questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies is not present in the provided text.

The closest relevant sections are:

• Mechanical and acoustic testing: "Dynamic evaluation of glenoid loosening or disassociation was performed per ASTM F2028-17." This refers to physical testing of the implant, not AI/ML performance.
• Clinical Studies: "Clinical data was not required." This explicitly states that clinical studies (which would involve human or AI/ML performance data) were not performed for this 510(k) submission.

Since the provided text does not describe an AI/ML device or its performance evaluation, I cannot generate the table or provide details about sample sizes, ground truth establishment, or expert involvement in such a study.

Ask a specific question about this device