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IN ANATOMIC:

The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

The AEQUALIS FLEX REVIVE Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The AEQUALIS FLEX REVIVE Shoulder System is indicated for use 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 other devices if sufficient bone stock remains

IN REVERSE:

The AEQUALIS FLEX REVIVE Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:

• Rheumatoid arthritis
• · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• · Correction of functional deformity
• · Fractures of the humeral head
• · Traumatic arthritis
• · Massive and non-repairable rotator cuff tear
• · Revision of the devices if sufficient bone stock remains

The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.

Notes:

• All components are single use.
• · The coated humeral stem is intended for cemented or cementless use.
• · The all-poly glenoid components are intended for cemented use only
• · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
• Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.

AEQUALIS FLEX REVIVE Shoulder System (AFR) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation. AFR includes a proximal body (metaphysis), spacer(s), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.

The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Ascend Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.

The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 180 mm (using the standard proximal body, spacers, and stem) in 10mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.

The proximal body, stem, and spacers are made from Ti6Al4V per ASTM F-136. The proximal body and stem have a Titanium plasma coating. The assembly screw and locking cap are made from of CoCr per ISO 5832-121. They are single use and packaged sterile, using gamma radiation at a minimum dose of 25 KGy to an SAL of 1x10-6.

The provided text describes the AEQUALIS FLEX REVIVE Shoulder System, a medical device, and summarizes the non-clinical performance testing conducted to support its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document summarizes non-clinical performance testing which typically involves bench testing of mechanical properties and material characteristics, not clinical studies with patient data. Therefore, the concepts of "test set sample size" and "data provenance (e.g., country of origin, retrospective/prospective)" as they relate to clinical data are not applicable here. The tests are performed on manufactured device components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth for mechanical and material tests is established by engineering specifications, recognized standards (ASTM, ISO), and analytical methods, not by expert consensus from clinical professionals for individual test cases.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for reconciling discrepancies in expert opinions on patient data. For non-clinical performance testing, compliance with predetermined acceptance criteria against recognized standards is the primary method of evaluation.

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 is a submission for a shoulder implant system, not an AI-powered diagnostic or assistive device for human readers.

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

Not applicable. This is a physical medical device (shoulder implant), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing and acceptance criteria is based on:

• Recognized Industry Standards: ASTM (e.g., F1378-12, D4169-16), ISO (e.g., 10993-1, 5832-121).
• Internal Engineering Specifications: Derived from device design, intended use, and comparison to predicate devices (e.g., specific torque values, cement mantle thickness targets).
• Comparative Analysis to Predicate Devices: Demonstrating that the new device's performance is not significantly inferior to that of a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" for the device's design and manufacturing would involve engineering principles, materials science, and previous product development experience.

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8.

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