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The Royale® AE 9045 injector is intended as a reusable instrument to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. It is designed to incorporate Alcon cartridges Type C for foldable intraocular lenses. The cartridge is loaded into the injector body and by pushing the piston. The lens will be removed out of the cartridge and delivered to the desired position.

The injector is an autoclavable, reusable titanium hand piece which is used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens.

The provided text is a 510(k) summary for the "Injector" device, a reusable titanium handpiece for delivering folded intraocular lenses (IOLs) during cataract surgery. To provide the requested information about acceptance criteria and study details, I need to extract this from the provided text.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials with precise acceptance criteria and performance metrics in the same way a PMA (Pre-Market Approval) submission would.

Here's what can be inferred and what is not explicitly stated in the provided text:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided 510(k) summary. The document mentions "performance tests" but does not detail the number of IOLs, cartridges, or test runs conducted.
• Data Provenance: Not specified. The manufacturer is Anton Meyer & Co. Ltd. in Nidau, Switzerland, suggesting the testing could have occurred there, but this is not explicitly stated.
• Retrospective or Prospective: Unclear, but typically, performance tests for a 510(k) submission are conducted prospectively as part of the device development and validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable and not specified. The "performance tests" described focus on the physical delivery of the IOL and its integrity, not on subjective expert assessment of an outcome which would require ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable and not specified. Adjudication methods are typically used when there's an ambiguity in interpretation (e.g., image analysis, clinical outcome assessment). The described performance tests are likely objective measurements of physical attributes.

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. The device is a mechanical injector for IOLs, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant here.

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

Not applicable. The device itself is a mechanical "standalone" instrument. There is no algorithm being evaluated in this context. The performance tests would be of the device's mechanical function.

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

The "ground truth" for the acceptance criteria would be based on objective physical measurements and visual inspection to ensure the IOL's "overall power, shape resolution or cosmetic attributes" are not adversely affected. This would likely involve:

• Dimensional measurements to verify shape resolution and overall power (if measurable after delivery).
• Optical inspection (e.g., microscopy) for cosmetic attributes (scratches, deformations).
• Functional tests to confirm the lens is delivered smoothly and correctly.
  The document doesn't detail the specific methods for these measurements.

8. The sample size for the training set

Not applicable. The "Injector" is a mechanical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model.

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

Not applicable for the same reason as point 8.

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