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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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