Search Results

Anatomic Total Shoulder or Hemi-Shoulder
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

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems).
• Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
• Difficult clinical management problems where other methods of treatment may not be inadequate.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• A severely painful, disabling, arthritic joint
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
• Revisions of previously failed shoulder joint replacements

The INHANCE™ Convertible Glenoid system consists of a Baseplate with minor modifications compared to the previously cleared Baseplate in K212737 and a poly insert that locks atop the Baseplate to allow for an anatomic procedure. The Convertible Glenoid Insert implants are offered in four sizes: Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Convertible Glenoid Insert implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and an interrupted fixation ring along with a finned central fixation post to facilitate poly locking to the Convertible Glenoid Baseplate.

The INHANCETM Convertible Glenoid Insert Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the INHANCE Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.

The INHANCE™ Convertible Glenoid Baseplates, previously cleared in K212737, were modified to provide for a means of mechanical fixation between the Convertible Glenoid Inserts and Baseplates.

The INHANCE Convertible Glenoid implants are compatible with the implants and instruments previously cleared for use in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737).

This document describes the regulatory approval for the INHANCE™ Convertible Glenoid device. It is a medical device, specifically a component of a shoulder arthroplasty system. Therefore, the "acceptance criteria" and "device performance" refer to the successful completion of specific non-clinical (mechanical, material, and biocompatibility) tests according to established standards, rather than the performance of an AI algorithm based on clinical data.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes the regulatory approval for a medical device (orthopedic implant), not an AI algorithm. Therefore, the concepts of "test set" and "data provenance" specifically for AI evaluation are not applicable in this context. The "test sets" here refer to the samples of the physical device or its materials subjected to various non-clinical (mechanical, material, biological) tests as outlined above. The provenance of these test articles would be the manufacturing process of the INHANCE™ Convertible Glenoid components.

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

This information is not applicable. For physical medical devices, "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM, ISO), which dictate testing methodologies and performance thresholds. These standards are developed and maintained by expert committees in relevant engineering and medical fields, but there isn't a "number of experts" establishing ground truth for a specific test set in the same way clinical data is evaluated for AI.

4. Adjudication Method for the Test Set

This information is not applicable. "Adjudication method" usually refers to resolving disagreements among human reviewers (e.g., radiologists) in AI or clinical studies. In the context of device testing, results are typically objective measurements against a standard, which are then analyzed and interpreted by qualified engineers/scientists.

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

This information is not applicable. An MRMC study is relevant to AI/diagnostic imaging devices. This document concerns the mechanical and material performance of an orthopedic implant.

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

This information is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this medical device, the "ground truth" is based on:

• Adherence to established international and national standards (e.g., ASTM F1378, ISO 10993-1, ASTM F2028, ASTM F1829, ASTM F2695, ISO 11607-1, ISO 11607-2, ISO 11137-1, ISO 11137-2).
• Engineering justifications and characterizations demonstrating equivalence to predicate devices and acceptable performance (e.g., non-worst-case for wear, identical material properties).
• Quantitative data derived from physical testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI algorithm and thus no training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no AI algorithm and thus no training set or ground truth for it.

Summary of Device-Specific Information:

The INHANCE™ Convertible Glenoid is a shoulder arthroplasty component. Its acceptance for market (substantial equivalence to predicate devices) was based on a comprehensive series of non-clinical tests and evaluations covering:

• Range of Motion
• Biocompatibility
• Porous Structure Characterization
• AO-HXLPE Material Characterization
• Glenoid Wear Rate Evaluation
• Dynamic Evaluation of Loosening/Disassociation
• Static Evaluation of Locking Mechanism
• Glenoid Fatigue Resistance
• MRI Compatibility
• Shelf-Life
• Sterilization Validation

All these tests met their respective acceptance criteria as defined by national and international standards (ASTM, ISO) and FDA guidance, ensuring the device's safety and effectiveness. Clinical testing was explicitly stated as "not necessary to demonstrate substantial equivalence."

Ask a specific question about this device