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The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.

The Abbott Medical Optics (AMO) irrigation sleeve is a device that is intended to direct irrigation solution across the shaft of the phacoemulsification tip, allowing the irrigation solution to enter the eye during ocular surgery. It is a small, molded component that is placed over the phacoemulsification tip. The proposed irrigation sleeve is made of silicone, with a hardness specification of 80+/-5 durometer units. The flow rate of the sleeve is greater than or equal to 18cc, with a length of 0.75 -1.50 inches.

The provided text describes the K103023 510(k) summary for the AMO Irrigation Sleeve. This device is a medical accessory, not an AI/ML powered device, so several of the requested sections (e.g., MRMC study, human reader improvement, AI assistance, standalone algorithm performance, AI training data) are not applicable.

Here's an analysis of the provided information:

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

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

The document does not specify the sample size for the testing of the AMO Irrigation Sleeve. The testing appears to be conducted in-house by Abbott Medical Optics, Inc. ("The proposed AMO irrigation sleeve has undergone testing..."). The provenance is therefore internal to the manufacturer. This is a non-clinical device so the concept of retrospective or prospective data does not apply in the same way as it might for a diagnostic AI device; the device is tested against established engineering and biological safety standards.

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

This information is not provided in the document. For a device like an irrigation sleeve, "ground truth" would likely be established through engineering specifications, validated test methods, and compliance with recognized standards (e.g., ISO for biocompatibility and sterilization), rather than expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. This device is an accessory that has its performance evaluated against engineering specifications and compliance with standards, not through clinical adjudication by experts.

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 AMO Irrigation Sleeve is a medical device accessory, not an AI-powered diagnostic or assistive tool.

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

Not applicable. The AMO Irrigation Sleeve is a medical device accessory, not an AI algorithm.

7. The type of ground truth used

The ground truth for this device is based on:

• Engineering Specifications: Defined parameters for hardness, flow rate, and length.
• International Standards (ISO): Compliance with ISO 10993-1 (biocompatibility), ISO 11137 (sterilization), and ISO 14971 (risk management).
• Validated Test Methods: Procedures to verify durometer, tensile strength, flow rate, and product integrity after sterilization.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for it in that context. The "ground truth" for its performance is established through adherence to manufacturing specifications and compliance with recognized industry and regulatory standards.

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