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The INHANCE™ SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• · Osteoarthritis
• · Post-traumatic arthrosis
• · Focal avascular necrosis of the humeral head
• · Previous surgeries of the shoulder that do not compromise the fixation

Fixation Methods:

The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only.

The INHANCE INTACT™ instruments are intended to be used during orthopedic surgery with INHANCE™ Anatomic Stemless Shoulder System. Cases and trays are intended to hold joint reconstruction instruments during the sterilization process and for storage.

The current submission adds INHANCE INTACT™ Instruments to the INHANCE Stemless Anatomic Shoulder System. The implant components of the system are unchanged. The INHANCEINTACT™ Instruments are designed to facilitate a subscapularis sparing total shoulder arthroplasty for the INHANCE™ Anatomic Stemless Shoulder System.

The INHANCETM SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis of individually packaged implants: a humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt- chromium) in combination with an anatomic glenoid (stainless steel x-ray marker pin embedded) or an anatomic hybrid glenoid featuring a metal central post (titanium alloy). All glenoid implants have a Cross-Linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE) bearing surface.

The provided submission does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML medical device. This document describes a traditional medical device (shoulder joint prosthesis and associated instruments), not an AI/ML-driven diagnostic or therapeutic aid.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not applicable or extractable from this 510(k) summary for an AI/ML device.

Here's a breakdown of what the document does state about testing and equivalence, in the context of a traditional medical device:

The submission focuses on demonstrating substantial equivalence of the "INHANCE INTACT™ Instruments" to predicate devices (K203108 and K212933) for use with the existing "INHANCE™ Anatomic Stemless Shoulder System."

Key points from the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section:

• No AI/ML Component: The device is a traditional orthopedic implant system and instruments. There is no mention of algorithms, AI, machine learning, or software functionality that would require performance metrics like sensitivity, specificity, or AUC against a ground truth.
• Implant Components Unchanged: The implant components of the INHANCE Shoulder System are identical to those of the predicate device.
• Focus on Instruments: The submission is primarily for the "INHANCE INTACT™ Instruments," which are new designs intended to facilitate a subscapularis sparing total shoulder arthroplasty.
• Non-Clinical Testing Only: "Clinical testing was not required to demonstrate substantial equivalence."
• Types of Non-Clinical Testing:
  • Biocompatibility Assessments: Conducted per ISO 10993-1 and FDA Guidance documents. The devices were found to be biocompatible.
  • Bench Testing: Covered "Design equivalence, equivalence of use of the device, material rationale and biocompatibility evaluation."

Therefore, I cannot populate the requested table and information points as they relate to AI/ML device performance criteria and studies. The provided text does not contain any of that specific kind of information.

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