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MYAH is intended to be used by an eye care professional:

• to measure the axial length of the eye in a population age 5 and above
• to capture and store digital images of the meibomian glands under near-infrared illumination in adult population.
  MYAH is not intended to be used in patients with cataracts.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a device called "MYAH," which is an AC-Powered Slitlamp Biomicroscope. The letter states its indications for use (measuring axial length and capturing meibomian gland images) and mentions it's a Class II device.

However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific questions you've asked about device performance and validation.

Therefore, I cannot provide the requested information based on the text provided.

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MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional. MYAH is not intended to be used in patients with cataracts.

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The provided FDA documentation for the Myah device (K211868) does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods typically associated with AI/ML device evaluations.

The document is a substantial equivalence (SE) determination letter for a traditional device (AC-powered slitlamp biomicroscope) used for measuring axial length, not an AI/ML diagnostic or assistive device. The letter updates an earlier SE determination to correct typographical errors.

Therefore, I cannot provide the requested information based on the given text.

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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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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.

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ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Clamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.

It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

The ARGOS is substantially equivalent to the predicate device identified previously:

• the ARGOS (Santec Corporation) that was cleared by the FDA on October 2nd, 2015(K150754) as the primary predicate as it has the most similar intended use and characteristics
• the IOLMaster 700 (Carl Zeiss Meditec) that was cleared by the FDA on June 29, ● 2015 (K143275, K170171) as an additional (secondary) predicate to support a new feature of reference image capture on the version of ARGOS in this submission.

The predicate devices are Class 2 devices to premarket notification, as defined per regulation number 21 CFR 886.1850. In addition, the predicate devices have product codes of MXK(ARGOS), and HJO(IOLMaster700).

The version of ARGOS in this submission is a modified version of the Argos cleared under K150754 which is substantially equivalent with regard to intended use, operating principle, function, materials, and energy source. The differences from the predicate ARGOS (K150754) that are subject of this 510(k) submission are:

• An additional feature of reference image capture function ●
• Labeling change including change in the intended use adding the feature of reference . image capture.
• . This image can be transferred to image guided devices in order to support the execution of preoperative plan.

The changes described in this submission do not affect how the hardware is used to acquire measurements as a biometer, nor do these changes affect the principle of operation of the device.

The provided document describes the ARGOS device, a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT), and its 510(k) submission for clearance. The document focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the ARGOS ver1.5 which includes a new "Reference Image functionality."

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in terms of specific quantitative thresholds that the new ARGOS ver1.5 needs to meet for its added functionality. Instead, it argues for substantial equivalence primarily by:

• Comparing technological characteristics of the new ARGOS (ver1.5) with its primary predicate (ARGOS K150754) and a secondary predicate (IOLMaster 700 K143275, K170171).
• Stating that the new feature (reference image capture) is similar to a feature already present in a legally marketed predicate (IOLMaster 700).
• Referring to compliance with recognized consensus standards for performance and safety.
• Highlighting that the core biometry measurement capabilities did not change from the primary predicate. The in-vivo repeatability specifications for measured parameters (Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, Keratometry, Astigmatism, Pupil Size, White-to-White) are listed as identical to the primary predicate, implying these performance metrics were already accepted.

Implied Acceptance Criteria and Reported Performance (from comparison tables):

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

The document does not specify the sample size for any clinical test set in terms of patient data. It primarily relies on bench testing and software verification/validation. The comparison of in-vivo repeatability values references the existing performance of the predicate device, not new clinical data for the ARGOS ver1.5 to prove equivalent clinical performance.

• Sample Size for Test Set: Not explicitly stated for patient data. The "Performance Testing" section refers to "bench tests" and "software verification and validation," which typically involve internal testing and simulations rather than patient samples for the new features. The existing in-vivo repeatability data cited appears to be from the primary predicate, not new testing on the modified device regarding its core measurement functions.
• Data Provenance: The document does not provide details on the country of origin of data or whether it was retrospective or prospective. Given the focus on substantial equivalence through design and testing against standards rather than new clinical trials for the added feature, such details are not expected to be prominent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. The document does not describe a clinical study involving human readers or expert-established ground truth for a test set, especially pertaining to the new "Reference Image functionality." The changes are assessed through engineering and software validation, and comparison to existing, already-cleared devices.

4. Adjudication Method for the Test Set

N/A. No clinical study with human readers and adjudication is described.

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

N/A. No MRMC study is described. The device is not an AI/CADe device that assists human readers in diagnosis. It's a measurement device with an added image capture utility.

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

The device itself is a standalone measurement instrument. Its "performance" is its ability to accurately measure ocular parameters and capture images. The "Performance Testing" section (12.1 and 12.2) effectively describes this standalone performance evaluation, focusing on:

• Bench tests: ISO standards, hardware specifications (axial/lateral distance, SNR, depth attenuation).
• Software verification and validation: According to FDA guidance and ISO standards.
• Cybersecurity review.

These tests demonstrate the device's capability to function as intended without human intervention for the measurement process itself, or for the image capture function. The usability evaluation ensures the human-device interaction is acceptable.

7. The Type of Ground Truth Used

• For biometric measurements: The "ground truth" for proving performance (cited from the predicate) would typically be established based on highly accurate reference devices or physical models, although the document doesn't detail the predicate's original ground truth methodology. For the new device, the claim is that its measurement capabilities have not changed and are thus equivalent to the predicate.
• For reference image functionality: The ground truth for this new feature would be its ability to capture and transfer an image. This is validated by functional testing and comparison to the secondary predicate (IOLMaster 700), which already has this function. There isn't a "ground truth" in the clinical diagnostic sense for an image capture tool beyond its intended function of capturing an image.
• For safety and performance standards: The "ground truth" is compliance with the specifications and limits defined by the international and national consensus standards (e.g., ISO, IEC, ANSI/AAMI).

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set in the typical sense of machine learning. It's a measurement instrument. The "Vision Planner software package" and "Argos UI software" are traditional software applications that undergo verification and validation, not model training.

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

N/A. No training set is involved.

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The Pentacam® is designed to take photos of the anterior segment of the cornea, pupil, anterior chamber and lens of the eye. To evaluate:

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

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

The Pentacam AXL is designed to take photos of the anterior segment of the eye to measures eye components such as Axial length, Corneal thickness, Anterior chamber depth, Corneal curvature, Corneal cylinder, Corneal cylinder axis and White-to-white-distance. 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 captures Scheimpflug images of the anterior eye segment through varying axes. The Scheimpflug images created during an examination are transmitted to the connected PC. The axial length of the eye is measured by interferometry.

Scheimpflug images can be captured within maximum 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 provided text describes the acceptance criteria and study proving that the Pentacam AXL device meets these criteria by demonstrating substantial equivalence to predicate devices (IOL Master 500 and Pentacam).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria (as implied by comparison to predicate devices) and Reported Device Performance:

The acceptance criteria for the Pentacam AXL are implicitly defined by its agreement with the predicate devices (IOL Master 500 and Pentacam) on various ophthalmic measurements. The study evaluated agreement using mean differences and 95% Limits of Agreement (LoA). The table below summarizes the reported performance for the overall eye population in comparison to IOL Master 500, which serves as the primary benchmark for the new functionalities (like axial length). Similar data exists for other eye populations and for comparison with the original Pentacam for parameters related to Scheimpflug imaging.

Note: The acceptance criteria are interpreted as the demonstrated agreement (Limits of Agreement) with the predicate devices, indicating that the Pentacam AXL performs within acceptable ranges compared to established devices. A separate de novo set of acceptance criteria is not explicitly stated, but the study design aims to show non-inferiority/agreement.

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

• Test Set 1 (Pentacam AXL vs. IOL Master 500):

  • Sample Size: 80 subject eyes (20 eyes in each of four pre-defined eye populations).
  • Data Provenance: Not explicitly stated as country of origin, but described as a clinical study comparing the Pentacam AXL with the IOL Master 500. This implies prospective collection for the purpose of this comparison.
  • Four Eye Populations: Normal eyes (phakic, no cataracts/corneal disease), eyes with cataracts, eyes with abnormal corneal shape (post-keratorefractive surgery), and eyes without a natural lens (aphakic/pseudophakic).

• Test Set 2 (Pentacam AXL vs. Pentacam):

  • Sample Size: 138 eyes of 138 patients.
  • Data Provenance: Not explicitly stated as country of origin, but described as a second agreement study. This implies prospective collection for the purpose of this comparison.

• Test Set 3 (In-house Precision Testing):

  • Sample Size: 40 eyes of 40 subjects.
  • Data Provenance: Described as "In-house Precision Testing," implying internal data collection.

3. 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. The study design is a comparison between two devices (Pentacam AXL and predicate devices), rather than an evaluation against a manually established ground truth by experts. The "ground truth" for the test set is effectively the measurements obtained by the predicate devices.

4. Adjudication Method for the Test Set:

This information is not provided. As the study is a direct comparison between device measurements, traditional adjudication methods involving expert review of images for diagnosis or measurement might not be directly applicable in the same way as, for example, a diagnostic AI study. The "adjudication" is implicitly the statistical comparison of measurements from two automated devices.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided text. The study focused on the agreement between the Pentacam AXL and existing devices (IOL Master 500 and Pentacam) for quantitative ophthalmic measurements. It did not involve assessing human reader performance, either with or without AI assistance.

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

Yes, the studies described are essentially standalone performance evaluations. The Pentacam AXL, an ophthalmic device, directly measures various eye parameters. The evaluations compare these direct device measurements against those from predicate devices or against repeat measurements from the same device (precision study). There is no "human-in-the-loop" aspect to these performance assessments; they assess the device's inherent measurement capabilities.

7. The Type of Ground Truth Used:

The type of ground truth used is comparison to legally marketed predicate devices.

• For axial length, corneal curvature, corneal cylinder, anterior chamber depth, and white-to-white distance, the IOL Master 500 served as the predicate/reference device.
• For central corneal thickness, and corneal shape parameters, the Pentacam Scheimpflug Camera served as the predicate/reference device.
• For the precision study, repeat measurements from the Pentacam AXL itself served as the reference for repeatability and reproducibility.

8. The Sample Size for the Training Set:

The document describes studies for device validation (performance testing), not for training a machine learning algorithm. Therefore, there is no "training set" mentioned or implied for an AI/algorithm in the context of device development as presented here. The Pentacam AXL is a measurement device, and the Scheimpflug images capture process and subsequent analysis are part of its inherent design, not machine learning that requires a separate training set.

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

As there is no training set for an AI/algorithm described in this submission, this question is not applicable.

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ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraccular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, White (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.

Argos is a swept-source based biometer that provides the biometry and keratometry of the eye prior to cataract surgery and aids in the selection of the appropriate IOL.

Argos processes 3 OCT images (B-scans) and 3 CMOS camera images per measurement in seconds - reducing procedure time and minimizing patient discomfort. From the OCT images the biometry parameters are evaluated by segmenting the cornea, iris, lens, and retina. The operator can edit the biometry parameters by manual adjustment: Axial length, Corneal thickness, Anterior chamber depth (or aqueous depth), Lens thickness, White-towhite (corneal diameter), Pupil size. The keratometry values: K-values (flattest and steepest meridians), Astigmatism (angle of flattest meridian), are evaluated from the CMOS camera image, in combination with the OCT information.

All distance/thickness parameters (Axial length, Corneal thickness, Anterior chamber depth, Lens thickness, White, Pupil size) are simultaneously measured from 2dimensional OCT images.

All the boundaries of ocular segments are detected and distances and thicknesses are calculated by taking into account the refractive indices of each medium.

Axial length is the distance from the corneal apex to the fovea or, more specifically, to the ILM (Internal Limiting Membrane). The calculation is performed as the sum of the thicknesses (after refraction correction) of the cornea, aqueous humor, lens and vitreous.

Corneal thickness is the distance between the anterior and the posterior apexes of the cornea divided by the cornea refractive index (1.375).

Aqueous depth is evaluated as the distance between the posterior surface of the cornea and the anterior surface of the lens divided by the refractive index (1.336).

Anterior chamber depth is the sum of corneal and aqueous humor distances.

Lens thickness is the distance between the anterior and the posterior surfaces of the lens divided by its refractive index (1.410).

Pupil size is the lateral distance between the two inner boundaries of the iris region.

White-to-white (Corneal diameter) is the lateral distance between the inner boundaries of the cornea-sclera interface.

K-values (Radii of flattest and steepest meridians) and Astigmatism are evaluated by the size and distance of the reflected images of the infrared LED ring projected onto the cornea.

Safety protocol is well integrated into the device in both hardware and software to ensure the safety of both the patient and the operator.

The control program on the computer runs on Windows. The operation panel on the display attached to the PC provides all the functionalities.

IOL calculation uses widely recognized formulas; Hoffer Q, Haigis, Holladay1, SRK/T, etc.

The provided document describes the ARGOS device, an optical biometer, and its performance evaluation. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the clinical studies in the format of a predefined threshold. Instead, it presents the device's performance in relation to a predicate device (Lenstar LS900) through various statistical measures, implying that performance comparable to the predicate or within acceptable clinical ranges constitutes "acceptance." The "repeatability" values can also be considered a form of performance criteria.

*   **Data Provenance:** A single U.S. clinical site; collected prospectively for the agreement study.

• Precision Study (Repeatability and Reproducibility - Table 17.2.2):

  • 43 healthy eyes (for both repeatability and reproducibility).
  • Data Provenance: Not explicitly stated, but generally part of the same prospective clinical study.

• Enhanced Retinal Visualization (ERV) mode Validation Study (Table 17.2.3 and 17.2.4):

  • Cataractous eyes: 45 eyes (23 right eyes) for comparison with Lenstar.
  • Healthy eyes: 43 consecutive healthy eyes for repeatability of ERV mode.
  • Data Provenance: Not explicitly stated, but generally part of the same prospective clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set beyond the clinical measurements themselves. The study primarily relies on the agreement between the ARGOS device and the predicate device (Lenstar LS900) as the reference for performance, and the precision of the ARGOS itself.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The clinical studies compare measurements between devices and evaluate the precision of the ARGOS device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study involving human readers' improvement with or without AI assistance was done or described. This device is an optical biometer for objective measurements, not an image interpretation AI system for diagnosis where human reader studies are typical.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are standalone performance evaluations of the ARGOS device. The ARGOS device is an automated measurement tool. The "Agreement Study" and "Precision Study" assess the device's inherent measurement capabilities. While an operator initiates measurements, the performance metrics (Axial Length, CCT, etc.) are generated solely by the device's algorithms and hardware.

7. The Type of Ground Truth Used

The "ground truth" for the clinical studies is implicitly established by:

• Predicate Device Measurements: The Lenstar LS900, an already legally marketed optical biometer, serves as the primary comparator. The assumption is that its measurements are an acceptable reference.
• Internal Consistency/Precision: The repeatability and reproducibility studies establish the device's consistency in its own measurements, which is a form of internal ground truth for precision.

There is no mention of "pathology" or external "outcomes data" being used as ground truth for parameter measurements in this context.

8. The Sample Size for the Training Set

The document does not specify a training set or its sample size. This is typical for medical devices that perform direct physical measurements rather than AI algorithms trained on large datasets for pattern recognition. The algorithms for biometry are based on physical principles (e.g., swept-source OCT) and established calculations, not machine learning model training in the conventional sense.

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

As no training set is described for an AI model, there is no information on how its ground truth was established. The device relies on physical measurement principles and established formulas (e.g., Hoffer Q, Haigis, Holladay1, SRK/T) for IOL power calculation.

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The PARK 1 is designed to photograph the eye and take Scheimpflug images of the anterior segment to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea. The implanted Ophthalmic Refractometer measures the refractive power of the eye.

The PARK 1 is a non-invasive, diagnostic system created to:

• take photos of the anterior segment of the eye
• measure the refractive power of the eye
• measure the central corneal K-values.
  The device is stationary and AC powered. The PARK 1:
• is based on the Scheimpflug Principle for Slit Image photography. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The device takes a series of images of the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software
• has a real keratometer to measure directly the central keratometer values as per definition in the 3.1mm ring.
• includes an Ophthalmic Refractometer to measure the refractive power of the eye (21CFR886.1760)
  The device consists of a measurement unit, built in CPU, head and chin rest and an external power supply.

This application for the PARK 1 device does not explicitly define "acceptance criteria" as a separate section with specific thresholds. Instead, the "Brief summary of nonclinical tests and results" section presents repeatability data, which implies that the device's performance is deemed acceptable if it demonstrates a certain level of precision for pachymetry and keratometry measurements. The substantial equivalence claim is based on similarity to predicate devices rather than meeting a predefined performance standard.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Given the lack of explicit acceptance criteria, the table below presents the reported repeatability measurements, which are the primary performance metrics provided for the device. The "Acceptance Criteria" column is inferred as the reported repeatability values themselves, implying that these values were considered appropriate for demonstrating substantial equivalence.

Detailed Study Information

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

   • Sample Size: 46 subjects (92 eyes).
   • Data Provenance: The study was "internally performed" by OCULUS Optikgeräte GmbH. It is retrospective, as the measurements were taken and then analyzed. The country of origin is not explicitly stated for the subjects, but the applicant is based in Germany.

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

   • Number of Experts: Not applicable. The study measured the device's repeatability rather than comparing its measurements to a "ground truth" established by experts. The measurements were taken by "the same operator" to determine how consistently the device performs.
   • Qualifications of Experts: Not applicable, as there were no experts establishing ground truth in this study design.

3. Adjudication method for the test set:

   • Adjudication Method: Not applicable. There was no ground truth that required adjudication. The study focused on the variability of the device's own measurements.

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:

   • MRMC Study: No. This study was a device repeatability study, not a comparative effectiveness study involving human readers or AI assistance. The PARK 1 is a diagnostic measurement device, not an AI-assisted diagnostic tool.
   • Effect Size: Not applicable.

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

   • Standalone Performance: Yes, in a sense. The study evaluated the device's intrinsic repeatability when operated by a single individual, focusing on the consistency of the device's measurements. The "algorithm" here refers to the device's measurement system. However, it's not a standalone AI algorithm.

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

   • Type of Ground Truth: Not applicable. The study aimed to determine the repeatability of the device's measurements, not its accuracy against an external gold standard or ground truth. Each measurement performed by the device on an eye served as its own data point for assessing consistency.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's an optical measurement device. Its internal algorithms are part of its fixed design, not learned from data.

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

   • Ground Truth for Training Set: Not applicable. As it's not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.

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