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The disposable single use soft tipped small incision injector (model number R-INJ-04/18) is intended to be used to compress and insert into the capsular bag only those IQL models that allow use of this injector in their approved labelling.

The single use small incision disposable injector (model number R-INJ-04/18 is intended to be used to compress and insert into the capsular bag only those intraocular Lenses that allow use of this injector in their approved labelling. It is designed to mechanically fold the lens and insert it into the eye during normal, small incision (1.8mm) cataract surgery. The small incision injoctor (model number R-1NJ-04/18 is a plastic single use disposable device. The injector components harrel, flap, nozzle, bush and sleeve are made of polypropylene. The plunger is made of polycarhonate. The injector is transparent and the plunger is white.

Here's an analysis of the provided text regarding the Rayner Single Use Small Incision Disposable Injector R-INJ-04/18, structured to answer your questions about acceptance criteria and study details:

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)

The document states: "Mechanical testing was completed to ensure that the injector functioned according to the requirements."

• Sample Size: The document does not specify the sample size used for the mechanical testing or any other tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location (Hove, East Sussex, UK) and the submission to the FDA, the testing was likely conducted in the UK or a facility approved by the manufacturer.

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)

The document does not provide any information on the involvement of experts for establishing ground truth. The testing described is "mechanical testing," which implies objective, measurable parameters rather than expert-derived ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for test results. Mechanical testing typically involves predefinedPass/Fail criteria for objective measurements, rather than subjective agreement among adjudicators.

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

This section is not applicable to the provided document. The device is a mechanical injector for intraocular lenses, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance would not be relevant.

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

This section is not applicable to the provided document. The device is a mechanical injector. There is no algorithm involved to perform in a standalone capacity. The "performance" described is the physical interaction of the device with an IOL and its insertion into a model or cadaveric eye as part of mechanical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "mechanical testing," the "ground truth" would likely be:

• Engineering specifications/measurements: Confirmation that the injector could successfully compress and insert the specified IOL models through a 1.8mm incision without deforming the IOL or encountering excessive resistance, as per design requirements.
• Visual inspection: "Visually observe that the lens is symmetrically folded within the loading bay" and for any trapped parts of the optic or haptics.
• Functional outcome: Successful insertion of the IOL into a model or cadaveric capsular bag.

The document does not explicitly state these as "ground truth" but these are inferred based on the description of mechanical testing and device function.

8. The sample size for the training set

This section is not applicable. The device is a mechanical injector, not a machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an AI model. The device underwent design, development, and testing according to established procedures.

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

This section is not applicable for the same reasons as point 8.

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