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The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.

The provided document describes the lioli™ IOL Delivery System and its substantial equivalence to a predicate device, but it does not contain detailed acceptance criteria or a comprehensive study report that directly proves the device meets specific performance metric acceptance criteria in a structured format.

The document discusses performance data in a general sense, focusing on non-clinical tests to demonstrate the device's functionality and safety by showing that the delivered IOLs were undamaged and within specifications.

Here's an attempt to extract and synthesize the requested information based on the provided text, noting where specific details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Implied/Deduced" Criteria: The document describes the results of the tests ("all delivered lenses showed no damages"), from which we can infer the unstated acceptance criteria (e.g., "no damages or scratches on IOLs post-delivery").

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

• Sample Size: Not explicitly stated. The document mentions "All lenses were delivered..." and "Each lioli™ IOL Delivery System were also evaluated...", which implies a sample was used but the exact number for IOLs or delivery systems is not provided.
• Data Provenance: Retrospective, as these are pre-market notification tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is AST Products, Inc., located in Billerica, MA, USA.

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

• Experts: Not applicable. The "ground truth" for the performance tests (e.g., integrity checks, dimensional specifications, optical properties) was established through objective measurements and standardized test methods (ISO standards), not through expert consensus or interpretation of subjective data.
• Qualifications: Not applicable for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests performed are objective measurements and observations (e.g., microscope inspection for damage, dimensional checks), rather than subjective assessments requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable. This device is an IOL delivery system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is a mechanical delivery system for IOLs, not an algorithm. Its "performance" is its ability to successfully deliver an IOL without damage, which was assessed in non-clinical tests.

7. The Type of Ground Truth Used

• Ground Truth: Objective measurements against predefined specifications and visual inspection. For example:
  • IOL optical properties: Measured in accordance with ISO 11979-2.
  • IOL mechanical properties (including sagitta): Measured in accordance with ISO 11979-3.
  • Damages/scratches: Visually inspected using a microscope.
  • Biocompatibility: Tested against known safety standards for materials.
  • Dimensional specifications: Compared against manufacturing specifications.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a mechanical medical device, not a machine learning model, and therefore did not require a "training set."

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

• Ground Truth Establishment: Not applicable, as there was no training set.

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