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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 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.

AI/ML Overview

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

Acceptance Criteria / Test	Reported Device Performance (Summary)
Mechanical Properties	The IOLs remained mechanically and optically undamaged after manipulation with the AS-9300 injection system.
Cytotoxicity Test	No evidence of causing cell lysis or toxicity. Met requirements.
ISO Systematic Toxicity Test	No mortality or evidence of systemic toxicity. Met requirements.
Intracutaneous Test	No erythema and no edema from SC test extract. Very slight erythema and no edema from SO test extract. Met requirements.
Maximization Sensitization Test	No evidence of causing delayed dermal contact sensitization. Not considered sensitizers.
Aging Study	IOLs remained mechanically and optically undamaged after manipulation with the injector (report included from Lenstec).
Sterilization Validity	Sterilization validity study performed and included for review.

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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