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The Aequalis Adjustable Reversed Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non repairable rotator cuff tear as a replacement of Shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains

The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis AscendTM Modular Reverse Shoulder System K110599.

The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.

The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:

• Uncoated,
• Hydroxylapatite (HAP) coated,
• HAP over titanium plasma spray (HAP/Ti PS) coated.

The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120):

The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.

The provided text from the FDA 510(k) summary (K141029) describes a medical device, the Aequalis Adjustable Reversed Shoulder System, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses:

• Device: Aequalis Adjustable Reversed Shoulder System (a shoulder joint prosthesis).
• Predicate Device: Tornier Aequalis Adjustable Reverse Shoulder System, K120739.
• Purpose of this 510(k): To add an additional stem configuration (without HAP Coating, with plasma titanium spray coating on a portion, and a fluted surface on a portion) and validate an alternate plasma titanium spray coating supplier.
• Non-clinical Tests: Performed to evaluate device performance per design requirements and risk analysis. These included:
  • Demonstration of design equivalence
  • Fatigue testing
  • Shear fatigue strength
  • Static shear strength per ASTM F1044
  • Static tensile strength per ASTM F1147
  • Abrasion resistance per ASTM F1978
  • Thickness per ASTM F1854
  • Mean void intercept length per ASTM F1854
  • Mean volume percent of void per ASTM F1854
• Conclusion: "All testing results met pre-established acceptance criteria." and "the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device."

Based on the provided text, I cannot answer your questions because the document describes a mechanical orthopedic implant, not an AI or algorithm-based medical device. Your questions are tailored for evaluating the performance of an AI/algorithm.

Therefore, for each of your specific questions, the answer is that the information is not available in the provided document.

Here's why:

1. AI/Algorithm Focus: The core of your questions (e.g., test set, ground truth, experts, MRMC studies, standalone performance, training set) directly pertains to the evaluation of AI/machine learning algorithms. The Aequalis Adjustable Reversed Shoulder System is a physical implant, and its evaluation focuses on mechanical and material properties.

I can only extract information that is present in the document.

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