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CS Imaging is digital imaging software intended to be used with Carestream Dental's digital imaging devices by healthcare professionals to display, adjust, make measurement, print, export and store digitized images to support image diagnosis in medical care, predominantly in dentistry.

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Unfortunately, the provided text does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for proving device performance.

The document is a 510(k) clearance letter from the FDA for a device called "CS Imaging." It primarily addresses the administrative details of the clearance, the device's classification, general regulatory requirements, and its indications for use. It confirms that the device is substantially equivalent to legally marketed predicate devices.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, data provenance, or the number of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• The type of ground truth used or how it was established for either test or training sets.

The "Indications for Use" section (page 3) describes what the software is intended to do (display, adjust, measure, print, export, and store digitized images to support image diagnosis in dentistry), but it doesn't detail any performance metrics or studies to validate these functions beyond the general determination of substantial equivalence.

Therefore, I cannot fulfill the request using only the provided text.

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CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis.

Not Found

This document is a 510(k) clearance letter for the CS Imaging software. It clears the device for marketing and states its intended use. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide any performance metrics as typically found in clinical studies.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria with detailed study results as requested in the prompt. While a substantial equivalence determination often relies on comparing technical characteristics and showing that the new device performs as intended and is as safe and effective as a predicate device, the detailed study data you've requested regarding acceptance criteria and performance metrics are not typically presented in the FDA's 510(k) clearance letter itself. These details would usually be found in the manufacturer's 510(k) submission summary or detailed study reports.

Therefore, I cannot provide the requested information based solely on the provided text. The document confirms that the CS Imaging software is cleared for marketing with the indications for use described, but it does not detail:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for test sets.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone performance studies.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

The provided text only includes:

• Device Name: CS Imaging
• Indications for Use: "CS Imaging software is intended to be used with Carestream's dental digital imaging systems by healthcare professionals to display, adjust, measure, print and store 2D digital images of the dento-maxillofacial region of the human anatomy to support image diagnosis."
• Regulatory Class: II
• Product Code: LLZ
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system

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