Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.

The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals.

Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.

The provided text describes a 510(k) premarket notification for the Sony UP-991AD / UP-971AD Hybrid Graphic Printers. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies in the typical sense of AI/CADe devices.

The acceptance criteria are implicitly defined by compliance with applicable standards and a comparison of technological characteristics to predicate devices. The study proving acceptance is a non-clinical performance testing suite.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim for a printer, the "acceptance criteria" are the characteristics of the predicate devices. The device performance is shown by demonstrating that the proposed device is either equivalent or an upgrade in these characteristics.

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

The document states "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE" and "hardware and software testing." It also explicitly says "SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE: Not applicable."

This indicates that no clinical test set was used in the traditional sense for evaluating diagnostic performance with patient data. The testing was likely internal engineering and quality assurance testing of the printer's functionality, safety, and compliance with standards. Therefore, information about sample size for a test set and data provenance in a medical imaging context is not provided and not relevant to this type of device submission.

3. 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)

Not applicable, as no clinical test set with medical imaging ground truth (e.g., diagnoses) was used. The evaluation centered on engineering specifications and adherence to safety standards.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. This device is a printer, not an AI/CADe system. No MRMC study was conducted.

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

Not applicable. This device is a printer, not an algorithm.

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

Not applicable. The "ground truth" for this device would be its technical specifications and performance against industry standards for safety, electrical compatibility, and output quality (e.g., resolution, printing speed, interface functionality). These are verified through engineering tests, not clinical "ground truth" methodologies.

8. The sample size for the training set

Not applicable. This is a hardware device (printer), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD only accepts digital signal inputs and the UP-X898MD accepts both analog and digital signal inputs. The printers are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce 325 dpi high resolution hard copy prints of still images captured by these systems for the patient record purposes or referrals. The images cannot be utilized for diagnostic purposes. Additionally, the UP-X898MD (Hybrid) Printer can store images on a connected USB flash drive.

The provided text is a 510(k) summary for the Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study to prove the device meets specific acceptance criteria for diagnostic performance.

Therefore, many of the requested sections about a study demonstrating clinical performance do not apply to this type of regulatory submission for this device. The device is a "Medical Image Hardcopy Device" which explicitly states "The images cannot be utilized for diagnostic purposes." Its purpose is to produce hard copy prints for patient records or referrals.

Here's an breakdown based on the provided text, highlighting what is available and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, AUC) for the proposed device, as it is a printer and not a diagnostic tool. Instead, it compares the technological characteristics to a predicate device to establish substantial equivalence.

Here's a table summarizing the comparison of technological characteristics, which serves as the basis for demonstrating equivalence and "performance" in this context:

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

• Not Applicable. This submission is for a medical image printer, not a diagnostic device that requires a test set of clinical data for performance evaluation in the typical sense (e.g., assessing an AI algorithm's accuracy). The "testing" referred to is hardware and software testing for safety and compliance with standards.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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:

• Not Applicable. This device is a printer and is specifically stated as not for diagnostic purposes. It does not involve AI or human readers for diagnostic interpretation.

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

• Not Applicable. This device is a hardware printer, not an algorithm.

7. The type of ground truth used:

• Not Applicable. No clinical ground truth (like pathology or outcome data) is established or used for this device's performance evaluation because it is a printer and not a diagnostic device. The "ground truth" for its performance is its adherence to technical specifications and safety standards.

8. The sample size for the training set:

• Not Applicable. This device is a printer, not a machine learning algorithm. It does not have a "training set" in the context of AI or diagnostic performance.

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

• Not Applicable. See point 8.

Summary of the Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets its "acceptance criteria" (which in this context are primarily safety, effectiveness for its intended use, and substantial equivalence to a predicate device) is based on non-clinical performance testing:

• Hardware and software testing: The submission explicitly states, "The safety and effectiveness of the proposed UP-D898MD and UP-X898MD Graphic Printers have been confirmed by hardware and software testing."
• Compliance with applicable standards: The printers comply with:
  • IEC 60601-1:2005 + C1:2006 + C2:2007
  • AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
  • IEC 60601-1-2:2007
• Comparison to Predicate Device: The side-by-side comparison (table above) demonstrates that while there are technological upgrades (e.g., increased resolution, faster printing, digital input), these "differences do not impact the safety and effectiveness of the printers for the intended use" compared to the predicate device (Sony Video Graphic Printer UP-850). The intended use itself explicitly states the images are not for diagnostic purposes.

Therefore, for this specific device, the "acceptance criteria" are related to its functional performance as a hardcopy printer, safety, and electromagnetic compatibility, all validated through non-clinical testing and comparison to an established predicate. No clinical studies (as typically understood for diagnostic devices evaluating disease detection) were performed or required, as explicitly stated under "SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE: Not applicable."

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The DRYVIEW CHROMA Imaging System is intended to provide hard copy images from digital imaging source output signals. The device is intended for use with DRYVIEW CHROMA film and reflective media. The device will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging). The images are to be used for medical diagnosis and referral to physicians and their patients. The DRYVIEW CHROMA Imaging System is not intended for use with FFDM or CR Mammography systems.

The DRYVIEW CHROMA Imaging System is an inkjet printing system. The DRYVIEW CHROMA Imaging System (CHROMA System) receives medical data including image and clinical report data from a digital modality. This data is received from medical image source devices (modalities) over a network and communicated to the CHROMA device via digital communication standard, DICOM. User control is performed directly by the modality or through the host control. The CHROMA System device prints the information received using piezoelectric inkjet technology. Tiny ink droplets are propelled from pizeoelectric nozzles in inige toenhology. " in media to form the image or report communicated by the digital modality. The CHROMA System device prints on transparent polyester based (film) as well as reflective (paper) media. Media is removed from a cartridge and transported into the CHROMA System device. Print data and media merge within the device. The CHROMA System employs the use of test patterns to verify imaging performance. A test pattern generator is incorporated to assure consistency between input signals and output density. Software is used to control the image management and machine functions. The information sent to the DICOM interface is used by the DICOM Interface to choose the correct set of printing parameters and halftone patterns for optimal image quality.

This looks like a 510(k) premarket notification for a medical imaging hardcopy device (an inkjet printer). Typically, for such a device, the "acceptance criteria" and "study" would focus on demonstrating that the output (the printed image) meets certain quality and consistency standards to be fit for medical diagnosis. However, the provided document focuses more on substantial equivalence to a predicate device and adherence to general safety and quality standards rather than detailed performance metrics of image quality that would be established through a clinical study.

Therefore, the information requested, particularly regarding clinical study details (sample size, ground truth, experts, MRMC studies), is largely not present in this document because this type of device (a printer) is evaluated differently than, for example, a diagnostic AI algorithm.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated for a "test set" in the context of clinical performance evaluation. The document describes meeting voluntary standards and substantial equivalence, which implies engineering and system-level testing, but not a patient-data-driven "test set" in the diagnostic sense.
• Data Provenance: Not applicable. The "data" are digital images from various modalities (CR, DR, CT, MRI) that the printer receives. The provenance of these images themselves is not relevant to the printer's performance evaluation as described.

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

• Not applicable. This device is a printer. Its performance is assessed through technical specifications and comparison to a predicate device, not by expert interpretation of printed images in a diagnostic study where ground truth would be established.

4. Adjudication method for the test set

• Not applicable. See point 3.

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. This is not an AI-assisted diagnostic device. It is a hardcopy printer. MRMC studies are not relevant nor mentioned.

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

• Not applicable. This is a printer, not a diagnostic algorithm. Its function is to reproduce digital images on physical media. Its "performance" is about faithful reproduction and reliability, not diagnostic accuracy.

7. The type of ground truth used

• Not applicable. The concept of "ground truth" for diagnostic accuracy (e.g., pathology, outcomes data) does not apply to a medical image hardcopy device like this. The closest analogous concept would be the fidelity of the printed output to the digital input, which is assessed through technical printing parameters and test patterns.

8. The sample size for the training set

• Not applicable. This is a hardware device (printer) with embedded software for control and image processing. It is not an AI/machine learning model that undergoes "training" on a dataset in the conventional sense.

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

• Not applicable. See point 8.

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This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR 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. Not for mammography use.

CYPHER implements the necessary DICOM services to receive DICOM print jobs and provides an interface for printing the received data on a Windows™ printer. The device is designed for use with the CANON imagePRESS™ C1 Digital Print System. It consists of an Intel® 945GSE Mini-ITX Board in a shielded enclosure. The user interface is implemented on either an attached monitor or via the remote desktop function inherent in Windows XP. Power is supplied via an external UL listed 12 volt power supply.

The provided text describes a medical image hardcopy device, the "Cypher DICOM Print Solution," and its FDA 510(k) summary. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and the comprehensive study proving its performance.

The document is a regulatory submission for substantial equivalence to a predicate device, focusing on its DICOM compatibility and ability to produce high-quality hardcopy printouts. It mentions "Performance Testing/Data" that demonstrated the device is "safe and effective, performs comparably to and is substantially equivalent to the predicate device," and that "Tests include: Software Validation and evaluation of hardcopy output." Beyond this general statement, specific acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth methods are not provided.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that the device meets these general criteria but does not provide specific quantitative metrics or results that would typically constitute detailed acceptance criteria (e.g., specific resolution targets, color accuracy thresholds, DICOM conformance test results with pass/fail ratios).

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

• Not provided. The document states "Tests were performed on the device," but gives no details about the size or nature of the test set, nor the provenance of any data used for evaluation.

3. 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)

• Not provided. While the device is intended for "medical image diagnosis use and referral" by "medical radiologists, imaging modality specialists," the document does not mention the involvement of experts in establishing ground truth for any performance testing.

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

• Not provided. The document does not describe any adjudication method, suggesting that such a method was either not relevant to the type of testing performed (e.g., functional and imaging quality evaluation for a printer) or not considered necessary for this 510(k) submission.

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 study was not done, nor would it be relevant for this device. This device is a "Medical Image Hardcopy Device (Printer)," not an AI-powered diagnostic tool. Its function is to print DICOM images, not to assist in image interpretation or diagnosis directly via AI. Therefore, an MRMC study measuring human reader improvement with AI assistance is not applicable.

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

• Yes, in the sense that the "device" (printer) was tested independently. The performance testing mentioned ("Software Validation and evaluation of hardcopy output") would inherently be a standalone evaluation of the printer's output quality and DICOM conformance. However, this is not an "algorithm only" in the context of an AI device, but rather a functional evaluation of a hardware/software system.

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

• Not explicitly stated in terms of diagnostic ground truth. For a printer, the "ground truth" would likely involve objective measures of print quality, color accuracy, resolution, adherence to DICOM standards for rendering, and potentially comparison to the digital image data itself. It's not about clinical diagnosis ground truth (like pathology or patient outcomes).

8. The sample size for the training set

• Not applicable / Not provided. This is a medical image printer, not an AI model requiring a training set in the conventional sense. The "training" would be more akin to software development and testing, not machine learning model training.

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

• Not applicable / Not provided. See point 8.

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The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide highresolution hard copy images from digital imaging source output signals. The device is intended for use with KODAK DRYVIEW media including DVM (DryView mammography) films. The imager will interface with a variety of digital modalities, including, but not limited to, CR (Computed Radiology), DR (Digital Radiology), CT (Computerized Tomography), MRI (Magnetic Resonance Imaging) and FFDM (Full Field Digital mammography). Image resizing is used to preserve true geometric size images. The images are to be used for medical diagnosis and referral to physicians and their patients.

The subject device and predicate devices use the same technical design base. The printers receive image data from the modality. User control is performed directly by the modality or through the host control. KODAK DRYVIEW imaging media is removed from a daylight cartridge and transported to the laser imaging station. Image data and media merge at the laser station and the film is scanned. The exposed media is transported through the integrated processor and exits the printer.

Software is used to control the image management and machine functions. AIQC (Automated Image Quality Control) matches printing power with film characteristics to provide consistently high image quality.

The CARESTREAM DRYVIEW 5850 Laser Imager is intended to provide high-resolution hard copy images from digital imaging source output signals for medical diagnosis and referral to physicians and their patients.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly describe a formal "test set" in the context of clinical or performance data. The evaluation of the device relied on compliance with standards and a comparison to a predicate device. Therefore, no information is available regarding:

• Sample size for a test set.
• Country of origin of data.
• Retrospective or prospective nature of data.

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

This information is not applicable as the document does not describe a study involving a "test set" that required expert establishment of ground truth for a diagnostic outcome. The device is a printer, and its performance evaluation focused on technical specifications and output quality.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

A MRMC comparative effectiveness study was not performed or reported in the provided document. The focus was on the device's technical performance and equivalence to a predicate, not on how its use might impact human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a standalone device in the sense that its primary function is to print images based on digital inputs. However, the document does not describe a "standalone study" in the common understanding of an algorithm's diagnostic performance without human interaction. Instead, it describes technical performance and image quality as objectively measured and compared to standards and a predicate device.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the technical specifications and image quality standards that the device is designed to meet, as well as the performance characteristics of the predicate device. It's about how accurately the printer reproduces digital images, not about diagnostic accuracy of the images themselves. The document states that "Medical personnel review images displayed by the subject device and its predicate. This offers ample opportunity for competent human intervention in case of a malfunction or other failure." This implies the ultimate "ground truth" for diagnostic purposes remains with the human medical expert reviewing the printed image.

8. Sample Size for the Training Set

This information is not applicable. The device is a hardware printer with software control, not an AI/ML algorithm that undergoes "training" with a dataset in the typical sense. Its design and automated functions (like AIQC) are built-in, not learned from a training set of images.

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

This information is not applicable for the same reasons as point 8. The "ground truth" for its internal calibration and quality control (AIQC) would be factory-set parameters and established film characteristics.

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The Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing medical diagnostic images from mammography systems. The UP-DF750 is a multi-format imager and also is intended for printing high-resolution diagnostic images from CT, MRI, CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended for use by medical radiologists or other appropriately trained medical personnel.

The Sony UP-DF750 Digital Film Imager is a device for digitally printing black and white still images with DICOM format. The Sony UP-DF750 Digital Film Imager is connected to a DICOM network and the image from a mammography, CT, MRI, CR, DR or other compatible medical imaging system (modality) is transmitted via the DICOM network. Whenever a DICOM file is received, the Sony UP-DF750 Digital Film Imager will understand the DICOM information and images will be formatted in the memory. Then, this information will be transferred to the Print Engine through an internal interface (VF). The data will be processed through sharpness, gamma curve and other types of compensation. The Sony UP-DF750 Digital Film Imager is intended to be used to print DICOM images obtained from a medical modality for the purpose of diagnosis.

This document is a 510(k) summary for the Sony UP-DF750 Digital Film Imager, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The purpose of a 510(k) submission is to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not to prove its performance against specific acceptance criteria through a clinical study or detailed performance evaluation.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with defined acceptance criteria.

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The LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film. The devices are intended to be used by trained medical personnel in a clinic or hospital environment.

The LASER IMAGER, DRYPRO MODEL 873 is a Medical Image Hardcopy Device to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning and it complies with the Federal Performance Standard 21 CFR Part 1040.10.

The provided text is a 510(k) Summary for a medical image hardcopy device, the LASER IMAGER, DRYPRO MODEL 873. This document does not describe acceptance criteria, device performance, or any study involving AI or human readers.

The document focuses on:

• Company and Submitter Information: (Konica Minolta Medical & Graphic, Inc.)
• Device Identification: LASER IMAGER, DRYPRO MODEL 873 (Medical Image Hardcopy Device)
• Classification: Class II, 21 CFR 892.2040, Product Code 90 LMC
• Predicate Device: DRY LASER IMAGER, DRYPRO MODEL 793 (K042133)
• Device Description: Functions as a dry film printer for medical images from various diagnostic equipment (CT, MRI, DSA, Digital Mammography).
• Indications for Use: To acquire and print images from diagnostic equipment on medical dry-film, used by trained medical personnel in clinics or hospitals.
• Substantial Equivalence: Claims substantial equivalence to the predicate device due to similar intended use and technological characteristics.
• Compliance Standards: Mentions IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1 for safety and radiation.
• Conclusion: Reaffirms substantial equivalence to the predicate device.
• FDA Correspondence: An FDA letter confirming the 510(k) clearance based on substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or AI-related metrics as it is not present in the provided text.

This 510(k) is for a hardware device (a printer), not an AI/ML software device. The evaluation process for such a device typically involves demonstrating adherence to safety standards, electromagnetic compatibility, and performance specifications like print quality and speed, usually by showing it is equivalent to a previously cleared device. It does not involve "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI diagnostic tool would.

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The Drystar AXYS is a free-standing dry film printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography.

The Drystar AXYS is a free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

The device is the new Drystar AXYS and it is a dry, B/W printer, using the direct thermal printing principle to produce continuous-tone images with medical diagnostic image quality onto plastic sheets which can be viewed on a light box. The printer is sold with two film input trays. Each tray can be adjusted to five different sizes (in inches) of film, including 8x10, 10x12, 11x14, 14x14 and 14x17. Three different types of film can be used in this new device, two for general purpose radiography and a new type of film for mammography, Drystar DT 2 M. The new mammography film comes in only two sizes 8x10 and 10x12. It is thicker than the general purpose radiography film in order to provide a wider range of optical densities. The printer also handles borders for mammography images in a different manner than for regular medical images.

The provided document is a 510(k) summary for the Drystar AXYS, a medical image hardcopy device (printer). It primarily focuses on demonstrating substantial equivalence to a predicate device (Drystar 5500) rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context of clinical AI/software performance.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this specific document, as it describes a hardware device that prints images, not an AI or software algorithm that analyzes them.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific "acceptance criteria" for clinical performance of an AI/software device, nor does it report performance metrics relevant to an AI/software's diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the closest equivalent to "performance" for this device relates to its printing capabilities and compliance with manufacturing standards.

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

• Not Applicable. This document describes a medical printer, not a diagnostic AI/software that would have a "test set" of patient data for performance evaluation. The "testing" mentioned refers to engineering and quality assurance activities for hardware and software functionality, as well as compliance with standards.

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

• Not Applicable. As above, no clinical test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set or adjudication is mentioned.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was Done

• No. This document does not mention any MRMC studies. The device is a printer, not a diagnostic aid that would involve human readers interpreting images with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Not Applicable. The device is a printer, not an algorithm. Therefore, there is no "standalone performance" study in the context of an AI/software algorithm.

7. The Type of Ground Truth Used

• Not Applicable. For a printer, "ground truth" in the clinical AI sense (e.g., pathology, outcomes data) is not relevant. The "truth" would involve whether the printed image accurately reflects the digital image data, has appropriate density, resolution, and is free from artifacts, which would be assessed through technical specifications and quality control, not clinical ground truth.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware printer, not an AI model that requires a training set of data.

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

• Not Applicable. As above, no training set or its ground truth is relevant for this device.

Summary of the Study (as described in the 510(k) summary):

The "study" described in the document is primarily an equivalence demonstration. It focuses on showing that the Drystar AXYS is substantially equivalent to a previously cleared predicate device, the Drystar 5500.

The key points of the equivalence demonstration and "testing" mentioned are:

• Comparison to Predicate: Detailed comparison of hardware and software characteristics to the Drystar 5500 (though the detailed table 3.1 is not provided in this excerpt).
• Intended Use Equivalence: Stating that the Drystar AXYS has the same indications for use as the Drystar 5500.
• Technological Equivalence: Asserting that the technological characteristics are "identical" to the predicate device.
• Quality Control Procedures: Stating that the device includes an automatic QC procedure to comply with MQSA. This is a crucial "test" for the mammography application.
• Consensus Standards Compliance: Testing against and meeting "a number of consensus standards for safety and electromagnetic compatibility."

In essence, the "study" for this device is a regulatory submission proving that a new version of a printer performs its basic function (printing diagnostic images) and meets relevant safety and quality standards, effectively demonstrating it is as safe and effective as a device already on the market. It does not involve clinical performance studies in the way one would assess a diagnostic AI or software.

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The Dry Laser Imager, DRYPRO Model 832 is intended to be used to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The output image is not a high resolution and DRYPRO Model 832 is not intended for use with FFDM systems.

The Dry Laser Imager, DRYPRO Model 832 is a Laser Imager to receive image data from diagnostic equipment such as CT, MRI, DSA and other medical devices and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, exposing unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning, but it complies with the Federal Performance Standard 21 CFR Part 1040.10. This device has no patient contacting materials and is intended to be used by trained personnel only. The output of the device is evaluated by additionally trained personnel capable of sufficient review to afford identification and intervention in case of malfunction.

This document describes the Konica Minolta Medical & Graphic, Inc. Dry Laser Imager, DRYPRO Model 832, a medical image hardcopy device, seeking 510(k) clearance. The device is intended to receive image data from diagnostic equipment (CT, MRI, DSA) and print it on medical dry-film. It explicitly states that the output image is not high resolution and is not intended for use with FFDM (Full Field Digital Mammography) systems.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a typical quantitative pass/fail format for clinical performance. Instead, it presents a comparison table between the new device (DRYPRO Model 832) and its predicate device (DRYPRO Model 771) to demonstrate substantial equivalence based on technical specifications and intended use. The implicit acceptance criterion is that the new device's performance characteristics are comparable to or improved over the predicate device, or any changes do not raise new questions of safety or effectiveness.

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

The document does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device for diagnosis. This device is a hardcopy printer. The evaluation for substantial equivalence relies on comparing technical specifications and intended use with a predicate device. Therefore, there's no explicitly defined "sample size" or "data provenance" as would be relevant for an algorithm's diagnostic performance. The testing would have focused on the device's functional performance, image quality, and safety standards, but the details of such internal testing are not provided in this summary.

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

Not applicable. As a medical image hardcopy device, the "ground truth" refers to the fidelity and accuracy of the printed image compared to the digital input and established image quality standards for medical prints. There are no mentions of "experts" establishing clinical ground truth for diagnostic purposes in this document, as the device does not perform diagnosis.

4. Adjudication Method for the Test Set

Not applicable for this type of device. Adjudication methods are relevant for evaluating diagnostic accuracy from algorithms or readers.

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

Not applicable. This device is a printer, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a hardware device for printing, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this hardcopy device would implicitly refer to the technical specifications of image quality (e.g., pixel size, density resolution, print fidelity) as verified against industry standards (like those in DICOM and potentially SMPTE patterns mentioned). It's about ensuring the printed output accurately represents the digital input according to established technical benchmarks, rather than a clinical ground truth for a diagnostic finding.

8. The Sample Size for the Training Set

Not applicable. This device is a laser imager, a hardware product, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on the film/thermal paper. This device is not intended for mammography use.

Digital Printer P6000D series Model P6000DU receives signals from diagnostic imaging equipment or a personal computer, and automatically prints and ejects the received image data on 8x10" sized film/thermal paper. It does not incorporate laser scanning unit. The control unit processes and controls image data and performs control of the whole device. This device is not intended for mammography use.

The provided text describes a 510(k) premarket notification for a medical image hardcopy device, the Digital Printer P6000D series Model P6000DU. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission for substantial equivalence to a predicate device, focusing on technical characteristics and compliance with general safety standards, rather than performance studies against specific acceptance criteria.

Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies from the provided text.

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