Search Results

The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and non-repairable rotator cuff-tear 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
• · Revision of the devices if sufficient bone stock remains.

The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:

• Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
• . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
• or humeral implants Aequalis Reversed FX2 ●

The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.

The document provided does not describe an acceptance criteria or study that proves the device meets specific performance metrics in the way a clinical or standalone study for an AI/algorithm-based device would.

Instead, this is an FDA 510(k) Premarket Notification for a medical device (Aequalis PerFORM Reversed and Aequalis PerFORM+ Reversed Glenoid – a shoulder prosthesis). The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to meet pre-defined performance acceptance criteria as would be typical for a diagnostic or AI device.

Here's how the information provided relates to your request, with an emphasis on what's not relevant for a typical AI/algorithm acceptance criteria study:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail numeric targets for performance metrics like sensitivity, specificity, or AUC, as these are not relevant for a mechanical prosthesis 510(k). The "acceptance criteria" here is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
• Reported Device Performance: The document lists "Performance Data" which consists of a series of non-clinical bench tests (mechanical testing). These demonstrate the physical properties and durability of the prosthesis. Examples include:
  • Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
  • Titanium Porous Structure Stereological Evaluation
  • Titanium Porous Structure Mechanical Verification
  • PerFORM Reversed Fixation Pull-out Test
  • Fatigue Test
  • Range of Motion Analysis
  • PerFORM Reversed Taper Pull-Off Test
  • Glenoid Loosening Test (100,000 cycles)
  • PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
  • PerFORM Reversed Lateralization Comparison
  • PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation
  • Direct Metal Laser Sintering (DMLS) Process Validation
  • Endotoxin (

Ask a specific question about this device