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The intended uses of the EP-1000 Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. 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. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

The intended uses are identical to the Codonics NP-1600 Series Medical Printers (Premarket notification K962364) as a color, reflective media imager. The intended uses are identical to the Seiko ColorPoint 1720 (Premarket notification K991282) in terms of color, reflective media output.

The EP-1000 Imagers are dry, thermal, color printer/imagers. The devices produce continuous tone, diagnostic quality B/W and color images on reflective, incident light viewed media. The images produced via dye-diffusion technology are photographic and medical color matched quality.

Digital images are input directly to industry standard parallel (IEEE 1284) or Universal Serial Bus (USB 1.1) interfaces. The EP-1000 recognizes only its own proprietary image format which employs a 24-bit, RGB encoding for each pixel to be printed. Lossy data compression is not employed. Software drivers can be written or adapted for a plurality of host imaging applications and operating systems, which can translate image data of any format to the EP-1000 format.

The EP-1000 does not process or alter the received image data in any way. Host imaging applications or drivers can be designed to pre-compensate image data with gamma, contrast, rotation, scaling, etc; but the EP-1000 can only print the image data as received.

Imaging is accomplished via directly-modulated discrete-element thin-layer linear thermal print head technology. The recording medium is heat activated dye-diffusion of color onto photographic quality ChromaVista paper. The image formation is accomplished without wet chemistry processing common to many laser film imaging systems in use today.

The provided text describes the Codonics EP-1000 Medical Color Dry Imagers, a medical image hardcopy device.

Here's an analysis of the acceptance criteria and study data based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for the EP-1000 Imagers. Instead, acceptance is primarily based on the device demonstrating substantial equivalence to predicate devices in terms of function, intended use, and performance characteristics for medical image hardcopy output.

The document highlights the following performance characteristics as important for medical image hardcopy devices:

• Fidelity of the modulation transfer function
• Spatial frequency response
• Color resolution
• Density response
• Full image field uniformity

The reported performance indicates that the EP-1000 meets these needs:

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is primarily an equivalence study, demonstrating that the EP-1000 Imagers are substantially equivalent to already legally marketed predicate devices.

1. Sample size used for the test set and the data provenance:
   The document mentions "printer resolution pattern testing, and clinical studies" but does not specify sample sizes for any test set (e.g., number of images, number of cases). The data provenance (country of origin, retrospective/prospective) is also not mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not specify the number of experts or their qualifications for establishing ground truth related to image quality or diagnostic suitability. It does state that the system is "intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians," implying these are the end-users who would evaluate image suitability.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   The document does not describe any adjudication method for the test set.

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 study was mentioned. This device is a hardcopy printer, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a hardware printer. Its "performance" is inherently standalone in the sense that it prints images as it receives them. The document states: "The EP-1000 does not process or alter the received image data in any way." Therefore, its performance is evaluated on the fidelity of the printed output based on the input, rather than an algorithm's diagnostic capabilities. "Laboratory tests have documented expected results consistent with predicate devices currently in commercial distribution, particularly with regard to the predicate NP-1600."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For output quality, the ground truth appears to be established by comparison to the "expected results consistent with predicate devices" and confirming "quality suitable for the intended medical imaging use" through resolution patterns (SMPTE) and density response. The document implies that images are "suitable for medical image diagnosis use and referral," suggesting expert judgment on diagnostic quality as an implicit ground truth, though not explicitly detailed.

7. The sample size for the training set:
   This device is a hardware printer, not a machine learning algorithm that requires a training set. Therefore, no training set sample size is applicable or mentioned.

8. How the ground truth for the training set was established:
   As there is no training set for this hardware device, this question is not applicable.

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