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The Kodak Color Medical Imager 1000 series medical printers are thermal print engines intended to produce continuous tone photographic quality hard copy output with integrated color management that adjusts printed colors to accurately match medical image monitors or user specified color profiles. The hardcopy output includes, however is not limited to, nuclear medicine, ultrasound, CT (especially 3-D reconstruction), MRI and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. Digital images can be acquired from, but not limited to local area networks (LAN), Internet, medical image storage devices, or directly from digital medical image capture modalities. The system of printer and physical image is not a high-resolution device and is not intended for use with FFDM systems.

The KODAK Color Medical Imager 1000 is intended for use as a hard copy device for output from imaging source modalities used in medical imaging diagnosis and referral. Electronic image information signals are managed in the KODAK Color Medical Imager 1000 and transformed to heat a color donor ribbon and drive color dyes to a receptor sheet using thermal dye sublimation technology.

The provided text does not contain detailed information about specific acceptance criteria related to device performance in terms of diagnostic accuracy, nor does it describe a study that quantitatively proves the device meets such criteria through a clinical trial or performance evaluation with human readers.

Instead, the document focuses on regulatory compliance, safety, and substantial equivalence to a predicate device based on technical characteristics and adherence to voluntary standards.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of acceptance criteria and reported device performance:

Missing Information (based on the provided text):

The document does not provide information on:

• Sample size used for the test set and the data provenance: There is no mention of a test set for performance evaluation in terms of diagnostic accuracy.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no diagnostic performance study, there's no ground truth establishment for a test set.
• Adjudication method for the test set: Not applicable as no diagnostic performance study is described.
• 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: This is a non-AI device (a medical imager/printer), so an MRMC study with AI assistance is not relevant or described. The document mentions "Medical personnel review images displayed by the subject device and its predicates. This offers ample opportunity for competent human intervention in case of a malfunction or other failure," which refers to the human role in the diagnostic process after the image is printed, not as part of an AI-assisted interpretation study of the device itself.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no diagnostic performance study is described.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm-based diagnostic device requiring a training set in that context.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The document describes a substantial equivalence determination study rather than a clinical performance study. The core "study" is a comparison of the KODAK Color Medical Imager 1000 to a predicate device, the Codonics EP-1000 Medical Color dry imager (K030690). The "proof" that the device meets acceptance criteria primarily relies on:

1. Similarity in Intended Use: The intended uses are stated to be similar.
2. Technological Characteristics: The subject device is stated to use the "same technical design base" as the predicate device.
3. Adherence to Voluntary Standards: The device meets recognized safety and performance standards (DICOM, SMPTE, UL 60950, IEC 60601-1-1, ISO 12207, and ISO 14971).
4. Safety Profile: Both devices have no patient contact and do not control other patient-affecting devices. The document highlights the role of human medical personnel in reviewing images as a safeguard.

In essence, the "study" is a regulatory submission process demonstrating that the new device is "as safe and effective" as a legally marketed predicate device based on direct comparison of its design, intended use, and compliance with general safety and performance standards, rather than a clinical trial measuring diagnostic accuracy using a test set and ground truth.

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