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The Pentacam AXL Wave is intended to image the anterior segment of the eye which includes the cornea, pupil, anterior chamber and lens. It is indicated for the evaluation of

• corneal shape,
• condition of the lens (opaque crystalline lens),
• the anterior chamber angle,
• anterior chamber depth,
• the volume of the anterior chamber,
• anterior or posterior cortical opacity,
• the location of cataracts using cross slit imaging with densitometry,
• corneal thickness,
• axial length,
• white-to-white distance.
• optical aberrations of the eye,
• and retroillumination imaging.

The Pentacam AXL Wave also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

The Pentacam AXL Wave is intended to image the anterior segment of the eye to measure eye components, such as corneal thickness, anterior chamber depth, corneal cylinder, corneal cylinder axis and white-to-white-distance. The axial length of the eye can be measured by a built-in interferometer. An also integrated aberrometer can determine the optical aberrations of the eye. By using retroillumination imaging, the back-lit eye can be observed.

The measured parameters can be used by physicians to calculate the power of the intraocular lens (IOL) implanted during a cataract surgery.

While rotating around the eye, the Pentacam AXL Wave captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to a connected PC.

Scheimpflug images can be captured within maximum of two seconds. Up to 138,000 genuine height values are measured and analyzed from the Scheimpflug images.

The Scheimpflug images are the basis for the height data which are used to calculate a mathematical 3D model of the anterior eye segment.

The mathematical 3D model, corrected for eye movements, provides the basis for all subsequent analysis.

The axial length of the eye is measured by interferometry measurements are done by a common Hartmann-Shack-Aberrometer. The retroillumination works similar to the illumination method of slit-lamps.

The medical device described, the OCULUS Pentacam AXL Wave, is a combination device that integrates functionalities from two predicate devices: the Pentacam AXL (K152311) and the LUNEAU SAS, VX120 (K143086). The submission focuses on demonstrating substantial equivalence to these predicates, rather than proving performance against specific quantitative acceptance criteria for de novo claims.

Here's an analysis of the provided text in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for the Pentacam AXL Wave does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or other performance metrics, nor does it provide a direct table of reported device performance against such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on the device conforming to established standards and showing that its combined functionalities are as safe and effective as the individual functionalities of the predicate devices.

However, the document lists various technical specifications and qualitative aspects that can be inferred as "performance characteristics" that are deemed acceptable because they are equivalent to or do not significantly deviate from the predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" or provide details on data provenance (country of origin, retrospective/prospective). The submission relies on "bench and clinical testing" to demonstrate safety and effectiveness and substantial equivalence to predicates, rather than presenting a de novo clinical study with a defined test set for performance metrics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The submission focuses on technical equivalence and compliance with established standards, not on a clinical validation study requiring expert-established ground truth.

4. Adjudication Method

This information is not provided in the document. As no specific clinical study with expert ground truth establishment is detailed, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not described or presented in the provided text. The document does not discuss human reader improvement with or without AI assistance. This device is an imaging and measurement device, not an AI-powered diagnostic algorithm with a human-in-the-loop component in the context of this submission.

6. Standalone Performance Study (Algorithm Only)

While the device itself is a standalone system, the provided text does not describe or present a separate "standalone" performance study akin to an algorithm-only evaluation for a machine learning model. Instead, it refers to "bench and clinical testing" which demonstrated the overall device's safety and effectiveness and its substantial equivalence to the predicate devices. The "algorithm" here refers to the underlying physics-based calculations (Scheimpflug analysis, interferometry, Hartmann-Shack principle) rather than a machine learning algorithm requiring separate standalone performance assessment.

7. Type of Ground Truth Used

Given the nature of the device (measuring physical characteristics of the eye) and the submission's focus on substantial equivalence to existing devices, the "ground truth" for the device's measurements would inherently be based on:

• Physical principles/measurements: The accuracy of Scheimpflug imaging for corneal shape, interferometry for axial length, and Hartmann-Shack for aberrations are based on established optical and physical principles.
• Comparison to predicate devices: The "ground truth" for proving equivalence is implicitly the performance and measurements obtained from the legally marketed predicate devices (Pentacam AXL and VX120), which themselves would have been validated against established clinical standards or other "gold standard" instruments.
• The document states "bench and clinical testing demonstrate that the Pentacam AXL Wave is as safe and effective as its predicate devices," suggesting that a comparison of measurements against the predicate devices was likely a core part of the "ground truth" for validation.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This indicates that the device's underlying computational methods for image processing and measurement are likely based on established deterministic algorithms (e.g., optical physics, mathematical modeling of 3D structures) rather than iterative machine learning models requiring large training datasets.

9. How Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" in the context of a machine learning model, the concept of establishing ground truth for a training set does not apply in this document. The device uses established optical and measurement principles, where the accuracy of its internal calculations and measurements would be validated through engineering verification and clinical validation against known physical standards or established clinical measurement methods, as reflected in the "bench and clinical testing" reference.

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