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The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including:

• Axial Length measurement of the eye by ultrasonic means.
• Implanted IOL power calculation, using the Axial Length measurement. .

The AXIS NANO is an ultrasonic system designed for ophthalmic use. It uses A type scaris for biometric measurements of the eye. The system is composed of a laptop computer connected an acquisition module. The A-scan probe (either TP-01-b or TP-02-las) connects to the acquisition module.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it states that "Laboratory testing... was conducted to verify that the AXIS NANO met design specifications and was substantially equivalent to the predicate devices." No concrete performance metrics or study results are presented.

Therefore, I cannot populate the table or answer most of your detailed questions based on the given information.

However, I can extract the following:

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

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

• Sample size: Not specified.
• Data provenance: Not specified (no clinical testing was performed).

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

• Not applicable as no clinical testing was performed and ground truth establishment by experts for a test set is not mentioned.

4. Adjudication method for the test set:

• Not applicable as no clinical testing or adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC or AI-assisted study was performed or discussed. The device itself is an ophthalmic biometer ultrasound system, not an AI diagnostic tool for human readers.

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

• The document implies that laboratory testing of the device (AXIS NANO Ophthalmic Biometer Ultrasound System) was done to verify it met design specifications. This would inherently be a standalone evaluation of the device's physical and functional characteristics. However, no specific "algorithm-only" performance akin to an AI model's standalone performance is detailed.

7. The type of ground truth used:

• Not explicitly defined, as no clinical study for "ground truth" establishment is detailed. The "ground truth" for the device's performance would be against its own design specifications and its measured performance compared to the predicate devices.

8. The sample size for the training set:

• Not applicable; this device is an ultrasound system, not an AI model requiring a training set.

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

• Not applicable; this device is an ultrasound system and does not have a training set in the AI sense.

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