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The AltiVate Reverse® Shoulder Prosthesis is indicated 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 RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

This 510(k) submission proposes updated Surgical Technique within labeling, to reflect alternative reaming method to prepare the glenoid surface for the AltiVate Reverse Glenoid wedge baseplate. The alternative technique does not replace the original technique; it adds a secondary method for the user. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced.

This 510(k) clearance letter is for a medical device (AltiVate Reverse® Glenoid), specifically a shoulder joint prosthesis, not an AI/ML-based device. The provided text details the regulatory clearance for the device itself and a minor update to its surgical technique within labeling.

Therefore, the input does not contain the information necessary to describe acceptance criteria and a study proving an AI/ML device meets them as requested in the prompt. The document describes a physical device, not a software or AI algorithm.

Here's why the prompt cannot be answered with the provided text:

• No mention of AI/ML or Software: The entire document refers to a "shoulder joint metal/polymer semi-constrained cemented prosthesis," a physical implant. There is no mention of algorithms, artificial intelligence, machine learning, image analysis, diagnostics, or any other software-based function.
• Performance Testing: The "Performance Testing" section states, "Design Control and Verification and Validation Activities performed, demonstrates substantial equivalence between the subject and predicate devices and did not raise different questions of safety and effectiveness." This refers to traditional engineering and biomechanical testing for a physical implant, not the evaluation of an AI model's performance on data.
• Acceptance Criteria for AI: The prompt specifically asks for acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC) and details about a study evaluating an AI model (test set size, ground truth, expert review, MRMC studies). None of this information is relevant or present in the provided 510(k) letter for a physical orthopedic implant.

In summary, the provided FDA 510(k) letter is for a physical medical device and does not contain any information about the acceptance criteria or study data for an AI/ML-based device.

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The AltiVate Reverse® Shoulder Prosthesis is indicated 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 RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.

The provided text is an FDA 510(k) clearance letter for a medical device called the AltiVate Reverse® Glenoid. It explicitly states that "Clinical data was not required." This means that the device was cleared based on non-clinical performance testing and comparison to predicate devices, rather than through a clinical study involving human patients.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, as no such clinical study was conducted or required for this 510(k) submission.

However, I can extract the information provided about the non-clinical performance testing and the basis for substantial equivalence.

Based on the provided document:

Accepted Basis for Clearance (Non-Clinical/Bench Testing):

Regarding the other requested information (which is not applicable to a non-clinical 510(k) clearance):

1. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance testing was non-clinical (bench testing).
2. Number of experts used to establish the ground truth... and qualifications: Not applicable, as no human expert-driven ground truth was established from clinical data.
3. Adjudication method for the test set: Not applicable, as no clinical test set was used.
4. 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 physical medical implant, not an AI or imaging diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical implant, not an AI or imaging diagnostic tool.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical testing, the "ground truth" was established by adherence to ASTM standards and demonstrated mechanical/material equivalence to the predicate device.
7. The sample size for the training set: Not applicable, as no clinical training set was used.
8. How the ground truth for the training set was established: Not applicable, as no clinical training set was used.

Conclusion stated in the document: "All testing and evaluations demonstrate that the subject device is substantially equivalent to the predicate device identified." This means the device met the acceptance criteria by demonstrating equivalence to a legally marketed predicate device through non-clinical performance testing.

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