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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 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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The Corvis ST is intended to measure the intra-ocular pressure of the eye in patients with less than 3 diopters of corneal astigmatism. In addition, the Corvis ST is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea.

The Corvis ST performs the following two functions: Tonometry and Pachymetry. The Corvis ST measures intraocular pressure without contact with the eye by applying an air puff to the eye. The eye is illuminated and during the air puff, a high-speed camera records the movement of the eye with more than 4000 images per second. The high-speed camera analyzes a sequence of 140 Scheimpflug images of the cornea to determine intra-ocular pressure. The Corvis ST measure corneal thickness and shape based on sectional images when the cornea is not influenced by the air puff. The pachymetry measurements of the Corvis ST and the cleared Oculus predicate use the same image processing routine for analysis to obtain corneal thickness measurements. Tonometry and pachymetry functions can be performed during the same evaluation or separately.

Here's a breakdown of the acceptance criteria and study details for the Corvis ST, based on the provided document:

Acceptance Criteria and Device Performance:

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Pachymetry (Clinical):
     • Test Set Size: 51 subjects (102 eyes).
     • Data Provenance: Internal study (implies data was collected by the manufacturer, likely prospective). No specific country of origin is mentioned, but the manufacturer is based in Germany.
   • Tonometry (Clinical):
     • Test Set Size: 120 eyes (40 eyes per IOP group).
     • Data Provenance: Not explicitly stated if internal, but likely collected prospectively for the purpose of the study. No specific country of origin is mentioned.
   • Pachymetry (Bench):
     • Test Set Size: "Several glass plates with several known thicknesses." Not a human sample size.
     • Data Provenance: Internal study.
   • Tonometry (Bench):
     • Test Set Size: Manometric controlled test eye (phantom). Not a human sample size.
     • Data Provenance: Internal study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Pachymetry (Clinical): Ground truth was established by comparing to measurements from the FDA-cleared predicate device, Pachycam (K041841). No human experts were explicitly mentioned for ground truth.
   • Tonometry (Clinical): Ground truth was established using the Goldmann applanation tonometer (Haag-Streit), which is considered a clinical standard. No human experts were explicitly mentioned for ground truth.
   • Bench Testing (Pachymetry & Tonometry): Ground truth was established by known physical standards (calibrated glass plates for pachymetry, manometrically controlled pressure chamber for tonometry).

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

   • No adjudication method involving human readers for the test set was mentioned or implied for either pachymetry or tonometry. The comparison was directly against established reference devices or physical standards.

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 MRMC comparative effectiveness study was mentioned.
   • The Corvis ST is a diagnostic measurement device (tonometer/pachymeter), not an AI-assisted diagnostic aid for human readers. Its performance is evaluated on the accuracy of its direct measurements against a reference, not on how it assists human interpretation.

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

   • Yes, the performance studies described are for the standalone device. The device takes measurements directly, and its output (IOP, corneal thickness) is compared to a reference standard. There is no human-in-the-loop component for the measurement process itself in these evaluations.

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

   • Pachymetry (Clinical): Ground truth based on measurements from an FDA-cleared predicate device (Pachycam).
   • Tonometry (Clinical): Ground truth based on measurements from a widely accepted clinical standard device (Goldmann applanation tonometer).
   • Bench Testing (Both): Ground truth based on known physical standards (calibrated glass plates, manometrically adjusted pressure chamber).

7. The sample size for the training set

   • The document describes performance studies, which are typically test sets. It does not provide information about a training set for the device's algorithms. The device's image processing routines are mentioned, and for pachymetry, it states they use the "same image processing routine" as the cleared predicate, implying established algorithms rather than ones newly trained for this submission.

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

   • Not applicable as no training set information is provided in the document. The device's underlying technology seems to rely on established image processing techniques and comparison against predicate devices rather than a de novo AI model that requires a distinct training phase.

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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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The Pachycam is designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. The implanted keratometer measures the central radii of the cornea.

The Pachycam is a non-invasive, diagnostic system created to take photos of the anterior segment of the eye, portable and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. 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 the anterior segment of the eye from one fixed location (180°) and analyses one, selected by software.

The Pachycam Scheimpflug Camera is a non-invasive diagnostic system designed to photograph the eye and take Scheimpflug images of the anterior segment of the eye to evaluate the thickness of the cornea. It also measures the central radii of the cornea using an implanted keratometer.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics in a structured table. Instead, it focuses on demonstrating substantial equivalence to a predicate device (OCULUS Pentacam) and safety. The key aspects of "performance" are implicitly related to its ability to perform its intended functions accurately, consistently, and safely, as shown by internal company studies.

However, based on the device description and comparison to the predicate, we can infer some performance aspects:

Study Proving Acceptance Criteria:

The document explicitly states: "The Pachycam is proven effective for its intended uses through internal company studies."

This indicates that internal testing was conducted by OCULUS Optikgeräte GmbH to validate the device's performance against its intended uses, including the evaluation of corneal thickness and measurement of central corneal radii. While the specific details of these internal studies are not provided in the publicly available summary, the FDA's clearance (K041841) suggests they found sufficient evidence to support the claims of safety and effectiveness for substantial equivalence.

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

The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the "internal company studies."

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set in the internal company studies.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for a test set. This detail is typically found in studies involving subjective interpretation of data, which may not be the primary evaluation method for a device like a Scheimpflug camera that provides quantitative measurements.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The submission focuses on substantial equivalence to a predicate device based on technical and functional similarity, and internal effectiveness studies, rather than a direct comparison of human reader performance with and without AI assistance. The Pachycam primarily provides objective measurements.

6. Standalone (Algorithm Only) Performance Study:

Yes, the "internal company studies" that proved the device effective for its intended uses can be considered a form of standalone performance study. The Pachycam is described as generating images and measurements, implying the algorithm's ability to perform these functions independently to evaluate corneal thickness and measure central radii. The device's "effectiveness" through these studies would refer to the performance of its built-in measurement algorithms in producing accurate data.

7. Type of Ground Truth Used:

The document does not explicitly state the specific "type" of ground truth used for the internal company studies. However, for a device measuring corneal thickness and radii, the ground truth would typically involve:

• Reference Measurements: Comparison to established gold standard devices or methods (e.g., ultrasonic pachymetry, other validated keratometers, optical coherence tomography).
• Clinical Correlation: Evaluation of the device's measurements against clinical findings and established norms.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is understandable as the Pachycam is described as an optical imaging and measurement device based on a physical principle (Scheimpflug principle) and its effectiveness is likely validated through its measurement accuracy against known standards, rather than through a machine learning model that requires explicit training data.

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

As no training set is mentioned or implied for a machine learning model, specific information on how ground truth for a training set was established is not applicable/not provided in this document. The device's functionality relies on optical physics and algorithms inherent to the Scheimpflug principle for image acquisition and measurement, not on a machine learning model that is "trained."

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

• • corneal shape,
• analyse condition of the lens (opaque crystalline lens), ●
• analyse the anterior chamber angle, ●
• analyse anterior chamber depth, .
• analyse the volume of the anterior chamber, .
• . analyse anterior or posterior cortical opacity,
• analyse the location of cataracts (nuclear, subcapsular and or cortical), using cross . slit imaging with densitometry,
• corneal thickness. ●

The Pentacam Scheimpflug Camera is a non-invasive, diagnostic system created to take photographs of the anterior segment of the eye, table mounted and AC powered. The system is based on the Scheimpflug Principle for Slit Image photography. The device consists of a measurement unit, power supply and a CPU. The measuring system uses blue light (UV-free) given to a slit to illuminate the eye, and a CCD-Camera for photography. The measuring system offers the possibility of automatically rotation to get photographs of every part of the eye. The system calculates from the photos a 3D-modell of the eye.

The provided text describes the Pentacam Scheimpflug Camera and its substantial equivalence to a predicate device, but it does not contain a detailed study report with specific acceptance criteria and performance data in the format requested.

Therefore, I cannot populate the table or answer most of the questions directly from the given input. The document is primarily a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence rather than presenting a full clinical study with quantitative performance metrics against predefined acceptance criteria.

Here's what I can extract and infer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: "internal company and independent clinical studies" are mentioned, but no details on country of origin or whether they were retrospective or prospective are provided.

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

• Not specified. The document does not describe how ground truth was established for any test sets.

4. Adjudication method for the test set:

• Not specified.

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:

• No, an MRMC comparative effectiveness study is not mentioned. The device is described as a diagnostic system based on the Scheimpflug principle, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results with and without AI.

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

• The device itself IS a standalone imaging and analysis system. The "algorithm" is integral to its function of calculating a 3D model and various ocular parameters from the acquired photos. The effectiveness mentioned in the text likely refers to the overall system's ability to produce these measurements, but no specific "standalone" performance study in the context of an AI algorithm only is detailed.

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

• Not specified.

8. The sample size for the training set:

• Not applicable as the document does not describe a machine learning algorithm that requires a separate training set. The device's operation is based on established optical and mathematical principles (Scheimpflug principle, 3D model calculation).

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

• Not applicable (see point 8).

Summary of what is present in the document relevant to performance and validation:

• The document states that "The Pentacam is proven effective for its intended uses through internal company and independent clinical studies."
• The primary method for demonstrating "effectiveness" (and substantial equivalence) described in the document is through comparison to a predicate device (NIDEK EAS-1000) based on shared technology (Scheimpflug principle, CCD camera, similar operating system) and intended uses (anterior segment photography and evaluation of corneal shape, lens condition, anterior chamber, pachymetry, etc.).
• It highlights safety aspects, such as being non-invasive, using eye-safe light intensity, and meeting electrical safety requirements.

To provide the detailed information requested in your prompt, a dedicated clinical study report or validation protocol for the Pentacam would be needed, which is not part of this 510(k) summary.

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