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The Galilei G6 Lens Professional) is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate:

• · Corneal shape
• · Pachymetry (corneal thickness)
• Position of the cornea relative to iris and lens
• · Anterior and posterior opacity
• · Anterior chamber angle
• · Anterior chamber depth
• · Volume of the anterior chamber
• · White-to-white distance
• · Pupil size
• · Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings)
• · Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry
• · Condition of the lens (opaque crystalline lens)
• · Lens shape
• · Crystalline lens thickness

The Galilei G6 Lens Professional is designed to additionally evaluate:

• Axial length

The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

The Galilei G6 Lens Professional is (in hardware and software) identical to the Galilei G4 Dual Scheimpflug Analyzer but features an additional biometry module (hardware and software) referred to as "EBR Accessory".

The Galilei G6 Lens Professional consists of the following functional units:

• Measurement Head Container for the cameras, light sources, monitor drivers and electron-● ics. The Placido disk and Dual-Scheimpflug imaging is integrated into the Measurement Head, which performs a 180-degree rotation during data acquisition.
• Main Monitor Display and navigation through the software, selection of functions. ●
• PC box Container of the power supply and the computer. Periphery (Main monitor, mouse ● and keyboard) is connected directly to the computer.
• . Elevation Table - Height-adjustable instrument table with locking wheels.
• EBR Accessory Container of the EBR main printed circuit board as well as the optical and ● mechanical components such as a scanner and a partial coherence interferometer used for biometry measurements. Mounted inside the PC box.

The GALILE! G6 device takes images of the anterior segment of the eye, which includes the cornea, iris, pupil, limbus, anterior chamber and crystalline lens. Topography and anterior segment tomography are calculated from those images.

A pair of slit light images are recorded simultaneously with two cameras placed at opposite sides at an angle of 45°. Due to the Scheimpflug principle, an angled orientation of the camera's sensor allows a sharp focus over the entire image in spite of the 45° recording angle.

The images are then analyzed and anterior cornea, anterior lens and iris surfaces are detected. This information is then used to reconstruct a three-dimensional model of the anterior chamber.

Twenty (20) concentric rings in the Placido are reflected on the anterior surface of the cornea and recorded by a top-view camera in the center of the measurement head. The sizes and shapes of the recorded rings are used to calculate the curvature of the anterior surface of the eye.

Both the Placido and Scheimpflug information are then merged to a single model of the eye.

The EBR Accessory enables the Galilei G6 to take an optical A-scan by means of partial coherence interferometry.

A beam of partial coherence infrared light is directed along the optical axis into the eye. Whenever it passes a transition between layers with different refractive indices (e.g., corneal surfaces, crystalline lens surfaces, retinal surfaces), a portion of the light is reflected back towards the reflected light is compared to a reference beam passing through a light path of adjustable optical length. The length of the reference arm is varied by a scanner.

When the optical lengths of sample arm and reference arm match to within the coherence length of the partial coherence light source, an interference peak is detected and the corresponding layer within the eye is deduced.

Here's a breakdown of the acceptance criteria and study details for the Galilei G6 Lens Professional, based on the provided document:

Acceptance Criteria and Device Performance

The device's performance was primarily compared to the Pentacam® AXL (predicate device) in terms of agreement, repeatability, and reproducibility of various anterior segment geometry and axial intraocular distance measurements. The Acceptance Criteria are implicitly defined by demonstrating substantial equivalence to the predicate device, meaning the G6's measurements should fall within clinically acceptable differences compared to the AXL. The document highlights that minor differences, if any, should not affect safety or effectiveness.

Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria as pass/fail thresholds for each metric. Instead, it aims to demonstrate "substantial equivalence" of the Galilei G6 Lens Professional to the Pentacam® AXL. The reported device performance is presented as repeatability and reproducibility values (SD and CV%) and a qualitative assessment of agreement with the predicate.

Summary of Study Findings:

• The Galilei G6 demonstrates substantially equivalent performance to the Pentacam® AXL, except for WtW, where device-specific offsets are acknowledged.
• Repeatability and reproducibility metrics are substantially equivalent to the Pentacam® AXL.
• Minor technological differences raise no new safety or effectiveness concerns.
• No adverse effects or complications were observed.

Study Details:

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

   • Test set sample size:
     • Clinical study: 105 eyes of 105 subjects (mean age 40.7 ± 16.3 years). This included various eye conditions: normal eyes, eyes with varying degrees of cataract (20 patients with cataract, some severe up to LOCS III grade 4), high myopia, high hyperopia, post-keratorefractive surgery, severe keratoconus (2 eyes), and prior crosslinking treatment (3 eyes).
     • In-house precision testing (normal eyes): 12 subjects.
   • Data provenance: Prospective, observational, one-center study. The country of origin is not explicitly stated, but the submission is from a Swiss company to the FDA.

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

   • The document does not explicitly mention the use of external experts to establish a "ground truth" for the test set in the traditional sense (e.g., gold standard diagnoses by multiple experts). Instead, the study's primary objective was to evaluate inter-device agreement, repeatability, and reproducibility by comparing the Galilei G6 measurements to those of the predicate device, the Pentacam® AXL itself. The Pentacam® AXL's established measurements served as the comparative benchmark. Therefore, the "ground truth" for the comparison was the measurements obtained from the predicate device within the clinical setting. The study evaluated agreement between devices rather than against an independently established gold standard from experts.

3. Adjudication method for the test set:

   • The document does not describe an adjudication method involving expert consensus for the test set. The study was focused on comparing measurements between two devices (Galilei G6 and Pentacam® AXL) and assessing the Galilei G6's internal consistency (repeatability and reproducibility).

4. If a multi-reader multicase (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:

   • No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. The device in question (Galilei G6 Lens Professional) is a diagnostic imaging and measurement device, not an AI-powered diagnostic aid that assists human readers. The study compared the device's measurements to a predicate device.

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

   • Yes, the performance study implicitly evaluates the device in a standalone capacity for generating measurements. While the device is "operator guided by monitor and joystick" (meaning a human operates it), the reported performance metrics (repeatability, reproducibility, and agreement of measurements) are inherent to the device's measurement capabilities. The study assesses the device's ability to produce consistent and comparable measurements to a predicate device, independent of diagnostic interpretation by multiple human readers.

6. The type of ground truth used:

   • The "ground truth" in this study was the measurements obtained from the predicate device (Pentacam® AXL), against which the Galilei G6's measurements were compared to demonstrate substantial equivalence. For assessing the Galilei G6's own precision, the repeated measurements from the device itself were used. The document does not describe the use of an independent gold standard (e.g., pathology or outcome data generated by methods entirely separate from anterior segment imaging devices).

7. The sample size for the training set:

   • The document does not mention a training set sample size. This is likely because the Galilei G6 Lens Professional is a measurement device based on physical principles (Scheimpflug photography, Placido ring imaging, partial coherence interferometry), not a machine learning or AI algorithm that requires a distinct training dataset in the typical sense. Any internal adjustments or calibrations would be part of the device's engineering and verification, not a separate "training set" as understood in AI studies.

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

   • As no training set is described for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply in this context. The device's measurement algorithms are based on established optical and physical principles.

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