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MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eve.

MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versatility for both A-scan and B-scan operations.

The A-Scan biometric unit of the Advent System has the following features: Operational modes - Automatic and Manual Probe alignment - LED fixation light and audio feedback Multiple eye categories - Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic IOL calculations - programs include the latest in SRK, Holladay and Hoffer Q Patient storage - up to 16 patients, including right and left eye User interface - standard computer keyboard Display - 9" high resolution white phosphor CRT Accessories - printer, video output

The B-Scan imaging unit of the Advent System has the following features: Scanning - 50 degrees sector scan probe, allowing eye view from wide variety of angles

Normal mode - requires selection of parameters Windowed mode - allows user selectable scanning angle Controls - depth, gain, contrast and brightness Display - 9" high resolution white phosphor CRT User interface - standard computer keyboard

Accessories - camera, printer. VCR

MENTOR Advent™ System uses the following transducer operations and characteristics:

A-Scan: There is a single ultrasound mode where the transducer is pulsed at a repetition frequency of approximately 5 Hz. The transducer is a non-scanning crystal with a frequency of approximately 8 Mhz. This system uses the same ultrasound transducer as in the predicate device.

B-Scan: There are two ultrasound modes, Normal and Windowed. The transducer is a single crystal mechanical sector probe with a center frequency of 11 MHz. It is housed in an oil-filled sealed chamber. The transducer sweeps 8 frames/sec. Sweep angle is 50°, pulse repetition frequency is 5.5 KHz and there are 275 transmitted lines per scan. In the Windowed mode, the size and position of the user selected window affects the pulse rate and spacing of the pulse, and thus the radiated field. Ultrasonic power measurements reported later have been made in the worst case condition,

This 510(k) summary explicitly states that the determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical. Therefore, there is no study described in the provided text that proves the device meets any acceptance criteria.

Response based on provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states, "The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical."

2. Sample sized used for the test set and the data provenance: Not applicable as no performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study was conducted.

4. Adjudication method for the test set: Not applicable as no performance study was conducted.

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 device described is an ophthalmic ultrasonic system, not an AI-assisted device. Additionally, no performance studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no performance study was conducted.

7. The type of ground truth used: Not applicable as no performance study was conducted.

8. The sample size for the training set: Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set in the conventional sense. No performance studies were conducted.

9. How the ground truth for the training set was established: Not applicable. This is a medical device, not an AI/ML algorithm. No performance studies were conducted.

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