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The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling

The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraccular lens that allow use of this injector in their approved labelling. The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip. There are different Injector sets based on the type of cartridge that is used (AS-9300-16, AS-93001620, AS-9300-24,AS-9300-2420). The product is manufactured according to the ISO 13485:2003 Quality Standards and Quality System Requlations. The Injector body is manufactured from Polycarbonate 144R Blue. The plunger assembly which consists of plunger, shaft and outer and inner cap is made up of, Polycarbonate 144R white and the spring is made of stainless steel (SS304) under validated conditions. The cartridge is made from medical grade lubricated polypropylene and the silicon tip is also from medical grade. The injector system will be delivered sterile.

The provided text describes the acceptance criteria and the study conducted for the ASICO SofTip Injector System but does not contain information about AI or machine learning. Therefore, I cannot address aspects related to AI/ML performance, training datasets, or multi-reader multi-case studies with AI assistance.

Based on the provided text, here's the information about the device's acceptance criteria and the study to demonstrate its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the mechanical performance testing (e.g., how many IOLs were tested). It refers to the "IOL's" (plural) remaining undamaged.

For biocompatibility tests:

• Cytotoxicity Test: Not specified.
• ISO Systematic Toxicity Test: Not specified (refers to "extracts" and "test article extracts").
• Intracutaneous Test: Tested on "rabbits." The number of rabbits is not specified.
• Maximization Sensitization Test: Tested on "guinea pig." The number of guinea pigs is not specified.

The data provenance is not explicitly mentioned as retrospective or prospective, nor does it specify the country of origin of the data beyond implying the studies were conducted to FDA and ISO standards. The tests were performed by "ASICO" or supplied by "Lenstec" (a predicate company) for the aging study.

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

This information is not provided in the document. The device testing primarily focuses on mechanical and biocompatibility properties, not diagnostic interpretation requiring expert ground truth establishment.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable as the tests performed are laboratory-based mechanical and biological evaluation, not clinical or image-based evaluations requiring adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is not an AI/ML-driven diagnostic or assistive tool. It is an intraocular lens injector system.

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

This information is not applicable as the device is not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the mechanical and aging studies, the "ground truth" was established by the physical and optical integrity of the IOLs after manipulation, determined through unspecified measurement methods.
For biocompatibility tests, the "ground truth" was established by the absence of adverse biological reactions (e.g., cell toxicity, systemic toxicity, irritation, sensitization), as measured by the specific ISO standard protocols.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a training set.

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

This information is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a training set.

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The Royale® AE-9036 LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens will be removed out of the cartridge and delivered to the desired position.

The injectors are autoclavable, reusable titanium hand pieces which are used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens. They are a modification to the previously cleared Injector Royale AE 9045 K023737. The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured.

The provided text describes a 510(k) submission for the "Royale AE 9036 LSP" intraocular lens injector. It includes information about tests performed to demonstrate the device's performance, but it does not provide a table of acceptance criteria with corresponding performance metrics in a defined quantitative format, nor does it detail a study that directly proves the device meets specific quantitative acceptance criteria.

The document primarily focuses on verifying the device's functionality and safety through mechanical, optical, and cleaning tests, largely in comparison to a predicate device and relevant international standards.

However, I can extract the relevant information based on the request, even if it's not presented in the exact requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table. Instead, it describes passing various tests to ensure the integrity of the IOL and the cleanliness and safety of the injector. The "reported device performance" is generally stated as "the instrument has passed all the necessary tests successfully."

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

The document does not specify the precise sample size (number of lenses, number of injectors, or number of tests) used for the performance tests. It refers to "the IOLs" and "the instrument" generally.

Data Provenance: Not explicitly stated, but given the manufacturer (ASICO LLC, USA) and the context of a 510(k) submission to the FDA, it is highly probable the testing was conducted in a controlled laboratory environment, likely in the US or by a recognized testing facility. The data appears to be prospective as it describes tests performed specifically for device qualification.

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

Not Applicable. The ground truth in this submission is established through objective laboratory testing (e.g., optical property measurements, mechanical property tests, microbiological analysis, irritation tests) based on recognized international standards (ISO 11979-2, ISO 11979-3) and internal protocols (Acrinol test, Bio-Burden test, Intra-ocular irritation test). It does not involve human interpretation or consensus for establishing the ground truth of a diagnostic outcome.

4. Adjudication Method for the Test Set

Not Applicable. As the tests are objective, laboratory-based evaluations against specified standards or criteria, there is no need for an adjudication method by experts in the typical clinical sense (like 2+1, 3+1). The "adjudication" is inherent in passing or failing the defined test protocols.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Royale AE 9036 LSP is an intraocular lens injector, a surgical instrument. The evaluation focuses on its mechanical, optical, and biological safety performance, not on human interpretation.

6. Standalone Performance Study (Algorithm Only)

Not Applicable. This device is a manual surgical instrument and does not incorporate an algorithm in the sense of AI or automated analysis. Its "standalone performance" is its functional performance as an injector for IOLs, which was evaluated as described in the "Tests Performed" section.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is based on:

• International Standards: Compliance with ISO 11979-2 (optical properties) and ISO 11979-3 (mechanical properties) for IOLs.
• FDA Guidance Document: Compliance with the FDA IOL Guidance Document.
• Objective Laboratory Test Results: Outcomes of Acrinol staining, microbiological burden assessment, and intraocular irritation tests.
• Visual Inspection/Assessment: For damage to IOLs after manipulation.

8. Sample Size for the Training Set

Not Applicable. This device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms. The tests performed are for device verification and validation.

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

Not Applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.

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