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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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The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

The Mastel 1 Folder is an ophthalmic surgical device designed for use in inserting a foldable intraocular lens into the eye. The materials, basic scientific concepts, physical properties and intended use of the Mastel 1 Folder are similar to those of the predicate devices.

The Mastel 1 Folder Implantation System is comprised of a medical-grade titanium handpiece, a material commonly used in reusable surgical devices. The handpiece rod is designed to accept a single-use cartridge. The handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The handpiece is provided to the customer in a plastic case in a non-sterile state.

Acceptance Criteria and Study for Mastel 1 Folder™ Implantation System

1. Table of Acceptance Criteria and Reported Device Performance

This document summarizes the safety and effectiveness for a device that is a mechanical inserter; therefore, the "acceptance criteria" are related to maintaining the physical integrity and optical properties of the intraocular lenses (IOLs) during the insertion process. The reported device performance indicates successful delivery of IOLs without degradation of their critical parameters.

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

• Sample Size for Test Set: 130 intraocular lenses (IOLs), ranging from 6.0 D to 23.0 D.
• Data Provenance: The study was an in vitro performance test. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards, likely in the U.S. or by a U.S. entity. The data is prospective in the sense that it was specifically generated for the submission to demonstrate device performance.

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

Not applicable. The study was an in vitro performance test of a mechanical device's ability to handle and deliver intraocular lenses without damaging them or altering their critical physical and optical characteristics. The "ground truth" was established by objective measurements of the IOLs post-delivery against their known specifications/tolerances. No human expert interpretation of images or clinical outcomes was involved in establishing this in vitro performance ground truth.

4. Adjudication method for the test set

Not applicable. As described above, the "ground truth" was derived from direct physical and optical measurements of the IOLs. There was no need for expert adjudication because the assessment was objective and quantitative, comparing measured parameters against acceptable ranges.

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. This device is a mechanical intraocular lens implantation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

Yes, a standalone in vitro performance test was conducted. The device (Mastel 1 Folder Insertion System) was used to deliver 130 intraocular lenses, and the IOLs were subsequently evaluated for various physical and optical parameters. This test assesses the device's performance directly and independently of any human-in-the-loop clinical use evaluation.

7. The type of ground truth used

The ground truth used was based on objective physical and optical measurements of the intraocular lenses (IOLs) after being processed by the device. These measurements (diopter, astigmatism, resolution, visual acuity characteristics, overall diameter, loop angles, and sagitta) were compared against acceptable standards or specifications for IOLs, ensuring the device did not negatively impact their functional integrity.

8. The sample size for the training set

Not applicable. This device is a mechanical tool, not an artificial intelligence or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

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

Not applicable. As this is a mechanical device and not an AI/ML system, no training set or its associated ground truth establishment methods are relevant.

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