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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 (<20 EU / device)

  The document states that these tests were performed "to demonstrate substantial equivalence to the predicate device," implying that the results of these tests met benchmark values or comparisons to the predicate device, although specific numerical results or direct comparisons are not provided in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable in the context of an AI/algorithm test set. The "samples" here refer to physical components of the prosthesis used in mechanical bench testing. The specific number of mechanical test samples for each test (e.g., how many glenoids were subjected to fatigue testing) is not provided in this summary.
• Data Provenance: Not applicable. These are laboratory bench tests on physical devices, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Experts and Qualifications: Not applicable. Ground truth, in the AI sense, relates to clinical diagnoses or interpretations, which are not part of this mechanical testing.

4. Adjudication method for the test set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This is a mechanical prosthesis, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Ground Truth: Not applicable in the AI/algorithm sense. The "ground truth" for these mechanical tests would be established by engineering specifications, material properties, and comparison to the predicate device's known performance characteristics.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

• Training Set Ground Truth: Not applicable.

In summary: The provided document is an FDA 510(k) summary for a physical medical device (shoulder prosthesis). It describes mechanical bench testing to demonstrate performance sufficient for "substantial equivalence" to a predicate device, rather than a clinical study or performance evaluation of an AI-based diagnostic or therapeutic algorithm, which is what your questions are primarily tailored to. Therefore, most of your questions are not directly applicable to the content of this specific document.

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