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The ANTERION is a non-contact ophthalmic imaging and analysis device for the eye. It is intended for visualization and measurement of the anterior segment and measurement of the axial length.

The analysis covers:

• · Cornea Thickness
• · Anterior Segment
  • o Anterior chamber width, depth, volume and angle parameters
  • o Lens Thickness
• · Axial Length

The ANTERION is a diagnostic imaging device for the eye. The technology is based on swept-source optical coherence tomography (SS-OCT) technology. The device itself has two basic component groups:

• ANTERION Hardware (Imager/Base) with integrated forehead/ chin rest: The . hardware includes imaging hardware (e.g., laser, LEDs, optics, detectors, hardware for spatial encoding) as well as a touch screen.
• . ANTERION Software (V.1.2.4) (PC): The ANTERION Software includes the main user interface. The software allows for device control, such as selection of examination(s) and imaging parameter(s). The ANTERION software provides an interface for a Medical Image Management and Processing System.

The ANTERION hardware is separated in three parts: the Base (bottom part), the Imager (top part), and the Head Rest (forehead/chin rest).

For examinations, the patient places his/her head in the forehead/chin rest. The Head Rest is mechanically and electronically connected to the Base and controlled via a joystick. Placed within the stand are a stepper motor with additional mechanical parts and a controller board, allowing the operator to move the motorized chin rest up or down for optimally positioning the patients' eye. An external fixation light is mounted at the forehead rest.

The Base mainly contains the power supply and PC connection of the device. In the Imager, the components for scanning, signal generation, and signal processing are contained.

The operator directly accesses two software modules, which are named AQM (acquisition module) and VWM (viewing module). The AQM allows selecting between examinations. The VWM shows acquired images, parameters, and reports.

The ANTERION device contains two imaging modalities, a scanning optical coherence tomography (OCT) modality and an infrared (IR) camera. The OCT modality allows for cross-sectional imaging and biometry, while the IR camera allows for en-face imaging of a patient's eye.

The ANTERION device provides four separate software applications (Apps) to acquire various imaging and measurements of the anterior segment of the eye: (1) the Imaging App (cleared under K211817), (2) the Cornea App, (3) the Cataract App and (4) the Metrics App. The Cornea App provides tomographic data and measurements paraments for the patient's individual corneal geometry and corneal characteristics. The Cornea App provides tomographic data and parameters, such as corneal curvature and thickness. The Cataract App provides key measurements for the cataract surgery planning, such as corneal thickness, anterior chamber depth and axial length. The Metrics App generates OCT images and scan parameters for the anterior chamber such as anterior chamber angle and volume. The four ANTERION Apps are locked/unlocked independently by a license mechanism for each App. The software implementation of these Apps is realized within the AQM and VWM.

This submission is to seek clearance for the Metrics App, Cataract App and Cornea App.

To function as intended, the ANTERION must be connected to a Medical Image Management and Processing system (MIMPS) with compatible interface. To date, HEYEX 2 / HEYEX PACS is the only available MIMPS with compatible interface.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the ANTERION device (K230897).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific thresholds for each parameter. Instead, it presents extensive "Repeatability and Reproducibility" data (precision analyses) from two clinical studies (B-2018-3 and B-2018-5). The implication is that the demonstrated precision values meet the internal acceptance criteria for the device's performance.

Therefore, the table below will present the reported device performance, which is implicitly what the device "met" to achieve clearance. It's important to note that specific numerical acceptance thresholds are not explicitly defined in the provided text. The reported values are the performance demonstrated by the device in the studies.

Table 1: Reported Device Performance (Repeatability and Reproducibility)

Note regarding Acceptance Criteria: The document states, "The device met all pre-determined acceptance criteria" under "Non-Clinical Performance Testing". For clinical performance, it states, "Results of the clinical performance testing demonstrate a favorable clinical performance profile that supports a determination of substantial equivalence." This implies that the demonstrated repeatability and reproducibility values, as detailed in the tables, were considered acceptable for the device's intended use. Specific numerical thresholds for each parameter are not provided.

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

The provided text details the sample sizes for the clinical studies which serve as the test sets for the device's performance.

• Study Protocol B-2018-3:

  • Sample Size:
    • Group A (open angle): 29 participants completed, data from 25 for precision analyses (225 scans). 27 for agreement analyses.
    • Group B (narrow angle): 27 participants completed, data from 27 for precision analyses (234 scans). 26 for agreement analyses.
    • Total enrolled: 30 Group A, 28 Group B.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

• Study Protocol B-2018-5:

  • Sample Size: 176 participants enrolled, 172 completed.
    • Group A (normal anterior segment): 27 participants.
    • Group B (cataract): 33 participants.
    • Group C (corneal abnormalities): 45 participants (38-43 for specific parameters in precision analysis tables).
    • Group D (post-keratorefractive surgery): 29 participants (28-29 for specific parameters).
    • Group E (pseudophakic/aphakic eyes): 41 participants (39-40 for specific parameters).
    • Scans: Varied per parameter and group, ranging from ~243 to 378 scans for precision analysis.
  • Data Provenance: Single clinical site in the United States. The study was prospective, observational clinical study.

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

The provided text does not explicitly state the number of experts or their qualifications used to establish ground truth for the test set.

It mentions:

• "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" for Protocol B-2018-3.
• "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed" for Protocol B-2018-5.

While it mentions manual correction and an "independent reading center," it does not specify the number of experts, their specialty (e.g., ophthalmologists, optometrists, or technicians), or their years of experience for establishing this ground truth.

4. Adjudication Method for the Test Set

The document mentions "Manual correction of ANTERION segmentation and manual editing of the scleral spur and angle recess points were performed as needed" and "Manual correction of ANTERION segmentation was performed by an independent reading center and manual placement of the angle recess points were performed."

However, it does not describe a formal adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements among multiple readers or for establishing the final "ground truth" if multiple experts were involved in these manual corrections. It implies that a single "manual correction" was applied, but the process for achieving a single corrected state from potentially multiple reviewers or iterations is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a standard MRMC comparative effectiveness study was not performed as described for AI assistance.

The studies compared the ANTERION device's measurements not to human readers' performance, but to other devices (CIRRUS HD-OCT 5000 and Pentacam AXL) for accuracy and to itself for precision (repeatability and reproducibility). The ANTERION is an imaging and measurement device, not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, a study of how human readers improve with AI vs without AI assistance is not applicable in the context described.

The studies assessed the ANTERION's ability to consistently and accurately measure ophthalmological parameters.

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

The performance results presented (Repeatability and Reproducibility) for the ANTERION device represent its standalone performance as a measurement device. The reported CV% values reflect the device's inherent precision in generating these measurements.

While manual corrections of ANTERION segmentation were performed in the studies, this was described as a step in processing the acquired images to enable measurements, rather than human "interpretation" of the algorithm's output for diagnostic purposes in a human-in-the-loop scenario. The repeatability and reproducibility are derived from the measurements produced by the device, sometimes after such manual adjustments. The overall goal was to demonstrate the consistent and accurate measurement capability of the device rather than a diagnosis assistance system.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment appears to be based on:

• Comparison to legally marketed devices: The studies performed "agreement analyses" with CIRRUS HD-OCT 5000 and Pentacam AXL, implying these served as reference or comparative ground truth for measurement accuracy. The details of these agreement analyses (e.g., Bland-Altman, Deming regression) are mentioned, but the specific numerical outcomes of these agreement analyses are not provided in the excerpt.
• Manual correction by experts/independent reading center: For measurements derived from image segmentation (e.g., angle parameters, corneal thickness, chamber depth), "manual correction of ANTERION segmentation" and "manual placement of the angle recess points" were performed. This suggests that the ground truth for these segmented features was established by manual review, presumably by qualified personnel, even though their qualifications are not specified.

Therefore, the ground truth is a combination of comparison to established ophthalmic devices and expert manual correction/review of segmented images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

The provided document describes the clinical studies for device validation/testing. It does not provide information on the sample size used for the training set of the ANTERION's algorithms. As a measurement device rather than an AI diagnostic algorithm in the typical sense, it's possible that its internal algorithms rely on established physical/optical models and calibration, not necessarily a large-scale "training set" of images in the machine learning context. However, if machine learning was used for segmentation, the training set details are not provided.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a "training set" or the use of machine learning for its algorithms, there is no information on how the ground truth for any hypothetical training set was established.

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The Myopia Master is an interferometer indicated for measuring the axial length of the eye and is intended as an aid to eye care providers.

The OCULUS Myopia Master integrates the axial length measurement function of the cleared OCULUS Pentacam AXL (K152311) into the cleared PARK 1 device (K073508), which is an ocular device that includes Scheimpflug imaging, autorefractometry and keratometry functionalities. The Myopia Master combines the following measuring functions in one unit: Axial length, Auto-Refractometer, Keratometer.

Here's a breakdown of the acceptance criteria and the study proving the Myopia Master device meets them, based on the provided FDA 510(k) summary:

It's important to note that the provided document is a 510(k) summary for a combination device (Myopia Master integrates functionalities from two previously cleared predicate devices: PARK 1 and Pentacam AXL). The focus of this 510(k) is on demonstrating substantial equivalence to existing devices, rather than establishing de novo performance for a novel device. Therefore, the depth of clinical study details for acceptance criteria might differ from a full PMA or de novo submission. The document primarily emphasizes that the integrated functionalities maintain the safety and effectiveness of the individual predicate devices.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly lay out "acceptance criteria" in a typical table format with specific numerical targets for accuracy, precision, sensitivity, or specificity. Instead, the "acceptance" is implied through the demonstration of substantial equivalence to predicate devices. The performance data section refers to compliance with safety and technical standards and software validation, but not specific clinical performance metrics with target values for this combined device's primary function of axial length measurement in a clinical population.

Implied Acceptance Criterion: The primary implied acceptance criterion is that the Myopia Master's performance, particularly for axial length measurement, is comparable in safety and effectiveness to its predicate device, the Pentacam AXL.

Reported Device Performance (as demonstrated by comparison to predicate):

Study Details Proving Device Meets Acceptance Criteria

The document states: "Only eyes without any ocular disease were evaluated during the clinical study performed for FDA clearance of this device, so it is unknown whether accuracy and precision when used in patients with ocular pathology will yield acceptable results." This indicates a clinical study was performed, but the details are very brief.

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

   • Sample Size: Not explicitly stated. The document mentions "clinical study," but does not provide the number of subjects or eyes included in the test set.
   • Data Provenance: Not explicitly stated (e.g., country of origin). It states "clinical study performed for FDA clearance of this device," which usually implies data from a regulated clinical trial, likely involving human subjects. The retrospective/prospective nature is also not specified, though clinical studies for clearance are often prospective.

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

   • This information is not provided in the document. For a device like this, the "ground truth" for axial length measurement is typically established by comparative measurements against a highly accurate, established gold standard biometer, rather than expert consensus on images.

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

   • This information is not provided. Given the nature of a biometry device, adjudication methods as typically used for image-based diagnostic AI (e.g., radiologists reviewing images) are less relevant. The "ground truth" would be the measurement from a reference device.

4. 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:

   • No, an MRMC study was not indicated or described. This device is an interferometer for measuring axial length, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Its clinical value is in providing an objective measurement.

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

   • Yes, implicitly. The device functions as a measurement tool. The "performance" refers to its ability to accurately and precisely measure axial length. While a human operates the device to capture the measurements, the "algorithm only" performance would be its measurement accuracy and precision compared to a gold standard, which would have been evaluated in bench and clinical testing. The document states: "Bench and Clinical testing demonstrate that the Myopia Master is as safe and effective as its predicate devices."

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

   • Not explicitly stated, but highly likely comparative measurements against a clinical gold standard biometer. For devices that measure parameters like axial length, ground truth is typically a direct measurement from a highly accurate, established clinical reference device (e.g., another clinically validated optical biometer) rather than expert review of images or pathology. The document's statement about only eyes without ocular disease suggests a focus on establishing accuracy in a "healthy" or "normal" population.

7. The sample size for the training set:

   • Not provided. As a non-AI measurement device (combining existing technologies), the concept of a "training set" in the context of deep learning models isn't directly applicable for its primary function. If there were internal software algorithms that involved data-driven optimization (e.g., for image processing to find edges for white-to-white), the data used for development or "training" of these algorithms is not detailed. The software uses algorithms adopted from previously cleared devices.

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

   • Not applicable in the context of a typical AI training set. For established measurement technologies, the "ground truth" is defined by the physical principles of measurement and validated against known standards and other devices. The document highlights that "The algorithms and functions for measuring, keratometry and refraction determination are unchanged from the PARK 1, while the algorithms and functions for measuring the axial length were adopted from the Pentacam AXL software." This implies leveraging the pre-established validity of the predicate devices' internal algorithms.

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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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