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The Sony IP Converter's (PC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time. The IPC can send medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room. The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

The NU-IP3T/NU-IP3R IP converters are devices for the transmission/reception of 4K or HD images over a network with low latency from devices equipped with 3G-SDI, HDMI, Display Port, or DVI image outputs. Connecting multiple IP converters via a network switch allows you to construct a network video transmission system for medical procedures.

This document is a 510(k) premarket notification for the Sony IP Converter NU-IP3T and NU-IP3R. It states that no clinical study was included in this submission (Section 9, page 6). Therefore, the information required to answer your request about acceptance criteria and a study that proves the device meets those criteria cannot be extracted from this document, as such a study was not performed or submitted.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Sony IP Converter NU-IP40S) through technological characteristics and non-clinical performance data.

Below, I am providing the information that explicitly states why a clinical study was not included, rather than attempting to infer or fabricate acceptance criteria and study details.

Information on Clinical Performance Data:

• Clinical Performance Data: "No clinical study is included in this submission." (Section 9, page 6)

Therefore, all other requested points about acceptance criteria, reported performance, sample sizes, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone performance are not present in this document as they relate to a clinical study that was explicitly not included.

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The Sony IP Converter's (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time.

The IPC can send audio visuals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room.

The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

The Sony IP Converter NU-IP40S is intended to transmit 4K or HD video and audio signals from endoscope system or other modalities equipped with 3G/HD-SDI video output via a high-speed optical fiber network with minimal delay.

Connecting multiple IP Converters via a network switch can construct a network video transmission system for medical procedures.

The provided document is a 510(k) summary for the Sony IP Converter NU-IP40S. This device is an "IP Converter" used for distributing patient images and audio-visuals within a hospital or clinical environment. It is classified as an "Endoscope and accessories" under regulation 21 CFR 876.1500.

The document states that no clinical study was included in the submission. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of clinical outcomes or human reader improvement, as this device primarily deals with technical image and audio-visual distribution.

However, the document does report on non-clinical performance data, which demonstrates the device's conformance to recognized technical safety and electromagnetic compatibility standards. These standards serve as the "acceptance criteria" for the non-clinical performance aspects of this device.

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

1. A table of acceptance criteria and the reported device performance

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 does not specify a "test set" in the context of clinical samples or data. The testing mentioned relates to non-clinical performance (conformance to standards). For such testing, a sample size typically refers to the number of device units tested, but this detail is not provided. Data provenance is also not applicable in this context as it refers to technical performance rather than patient data.

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. The non-clinical performance data involves testing against established technical standards, not expert-derived ground truth on clinical images.

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

Not applicable, as no clinical test set or adjudication process is described.

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. The document explicitly states: "No clinical study is included in this submission." This device is an IP converter for image/audio distribution, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

Not applicable. This device is a hardware IP converter for signal distribution, not an algorithm.

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

Not applicable. For non-clinical performance testing against technical standards, the "ground truth" is the specifications and requirements defined by those standards.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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The LCD Monitor is intended to provide 4K 2D color video displays of images from endoscopic / laparoscopic camera systems and other compatible medical imaging systems. The LCD Monitor is a wide-screen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

The Sony LMD-X310S. LMD-X310MD and LMD-X310NB are 31 inches LCD monitors, and LMD-X550S. LMD-X550MD and LMD-X550NB are 55 inches LCD monitors with an advanced display technology, designed for use in medical environments. These monitors provide 4K resolution 2D color video displays of images from a surgical endoscope, laparoscopic camera system, and other compatible medical imaging systems. They are suitable for environments such as operating rooms. surgical centers, clinics, doctor's offices, and similar locations.

LMD-X310S、LMD-X310MD and LMD-X310NB are operated by DC power supply and supplied with a dedicated AC adaptor, AC-300MD. LMD-X310MD is SONY brand model, LMD-X310S is a model for a specified customer and LMD-X310NB is for unspecified customers.

MD-X550S, LMD-X550MD and LMD-X550NB are operated by AC power supply. LMD-X550MD is SONY brand model, LMD-X550S is a model for a specified customer and LMD-X550NB is for unspecified customers.

Key features include:

• A Large and 4K Screen
• Wide color qamut
• Clear and High-contrast View
• A.I.M.E.™ (Advanced Image Multiple Enhancer)
• Narrow Bezel
• Ergonomic Design
• User-friendly Control Panel
• A Variety of Display Format
• Easy to Clean
• Installation-friendly Cabling

This document describes the regulatory submission for Sony LMD-X310S, LMD-X310MD, LMD-X310NB, LMD-X550S, LMD-X550MD, and LMD-X550NB LCD Monitors. The submission focuses on demonstrating substantial equivalence to a predicate device, the SONY LMD-2451MT LCD MONITOR.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" with specific numerical values for performance metrics that the device had to meet. Instead, it states that the devices conformed to recognized standards and that bench testing "met pre-defined design and performance acceptance criteria."

The performance characteristics are largely presented in a comparative table with the predicate device, focusing on technological characteristics rather than specific "acceptance criteria" against which performance was measured.

Functional Performance Comparison (derived from Section 5.6):

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

The document mentions "bench testing as part of required performance verification and validation activities" (Section 5.7) and states that "Results show that the subject device has met pre-defined design and performance acceptance criteria." However, it does not specify any sample size for the test set or the provenance of any data. The testing appears to be functional and safety testing of the device itself, rather than testing on a dataset of medical images.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission focuses on the safety and performance of a medical display monitor and its substantial equivalence to a predicate device, not on diagnostic accuracy based on expert interpretation of medical images. Therefore, no experts were used to establish ground truth for a test set of medical images, as such a test set is not described.

4. Adjudication Method for the Test Set

Not applicable. As no test set involving expert interpretation is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "No clinical data was collected to support substantial equivalence between the subject and predicate devices" (Section 5.8). Therefore, no MRMC study was performed, and no effect size for human reader improvement with AI assistance is provided.

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

Not applicable. This device is an LCD monitor, a hardware device for displaying images, not an algorithm or AI system for image interpretation. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is implicitly defined by its ability to meet recognized performance and safety standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2) and pre-defined design specifications through functional bench testing. It's not related to medical image interpretations, pathology, or outcomes data, as this is a display device.

8. The Sample Size for the Training Set

Not applicable. As the device is a medical monitor and not an AI/ML algorithm, there is no training set involved.

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

Not applicable. Since there is no training set, this question is not relevant.

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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 Sony PVM-2551MD OLED Monitor is intended to provide color video displays of images from surgical camera systems. The PVM-2551MD is a widescreen, highdefinition monitor for real-time use during minimally invasive surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery.

The Sony PVM-2551MD OLED Monitor is a color video monitor and is intended primarily for use in a medical environment for displaying images captured during minimally invasive and general surgical procedures. The monitor features a 24.5inch widescreen OLED panel and Sony's TRIMASTER™ technology, which has been developed to provide accurate color reproduction, precision imaging, and quality picture consistency. The monitor employs full high-definition (HD) performance with 1920 x 1080 pixels, an aspect ratio of 16:9, and a pixel efficiency of 99.99%. OLED (an acronym for Organic Light-Emitting Diode) is a flat-panel screen technology that represents an advance in display technology. It is an emissive technology that generates light from each pixel. The process that is the basis of OLED is electroluminescence. In the Sony PVM-2551MD OLED Monitor, the OLED panel makes use of an organic material, which emits light when an electric current is applied. Being self-emitting, the strength of luminescence can be controlled by the amount of electric current. This results in quick motion picture response, high contrast and wide dynamic range, and rich color reproduction. In addition to digital signals, the Sony PVM-2551MD OLED Monitor accepts analog signals and converts them to digital signals. The Sony PVM-2551MD OLED Monitor is designed with the flexibility to support a variety of formats as standard and also has two built-in option slots to select, expand, and change input/output signals.

Please note that the provided 510(k) summary for the Sony PVM-2551MD OLED Monitor does not describe a study involving AI or machine learning for medical diagnosis or classification. Therefore, I am unable to provide information on topics such as AI effectiveness, expert ground truth adjudication for AI, or training/test set details for AI.

The document describes a medical monitor, which is a display device, not an AI-powered diagnostic tool. The "Performance Testing" section is very brief and focuses on compliance with recognized standards for electromagnetic compatibility and electrical safety, which are typical for hardware devices.

Here's the information based on the provided document, with an emphasis on what is present and what is explicitly not present:

Acceptance Criteria and Device Performance Study for Sony PVM-2551MD OLED Monitor

This document describes the 510(k) submission for the Sony PVM-2551MD OLED Monitor, a color video monitor intended for displaying images captured during surgical procedures. The performance testing described focuses on the device's compliance with safety and electromagnetic compatibility standards, rather than diagnostic accuracy or an AI algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This document describes performance testing for a hardware display device, not an AI or diagnostic algorithm that would typically use a "test set" of patient data. The testing mentioned refers to engineering compliance tests.
• Data Provenance: Not applicable. No patient data or medical images were used for performance evaluation in the context of a "test set" as understood for AI devices. The testing relates to the device's physical and electronic characteristics.

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

• Not applicable. Ground truth, in the context of medical image interpretation for an AI device, is not relevant to the evaluation of a display monitor.

4. Adjudication Method for the Test Set

• Not applicable. No "test set" of medical cases requiring expert adjudication is described.

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

• No. This document does not mention an MRMC study. The device is a display monitor, and the study described is not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No. This device is a display monitor, not a standalone algorithm.

7. Type of Ground Truth Used

• Not applicable. Ground truth for diagnostic accuracy is irrelevant for evaluating a medical display monitor's compliance with safety and EMC standards.

8. Sample Size for the Training Set

• Not applicable. There is no AI or machine learning algorithm described, and thus no training set.

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

• Not applicable. There is no AI or machine learning algorithm described, and thus no training set or ground truth establishment relevant to AI.

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The Sony LMD-2451MT LCD Monitor is intended to provide 3D and 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. The LMD-2451MT is a widescreen, high-definition, medical grade monitor for real-time use during minimally invasive surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.

The Sony LMD-2451MT LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 24-inch widescreen LCD display panel and employs full WUXGA high-definition (HD) performance. The LMD-2451MT also features Sony's ChromaTru® technology for accurate and consistent color matching across multiple monitors. The monitor is 2D/3D switchable and, therefore, is compatible with both 2D and 3D camera systems to show color and texture variations in full HD in both 2D and 3D modes. In addition to digital signals, the LMD-2451MT accepts analog signals and converts them to digital signals. The 3D mode of the Sony LMD-2451MT LCD Monitor enables more realistic depth perception and spatial orientation than is available in the 2D mode. A micro-polarizer 3D filter is built into the monitor and lightweight circular polarizer 3D glasses are supplied as accessories. The Sony LMD-2451MT LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.

The provided text is a 510(k) summary for a medical device, the Sony LMD-2451MT LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria beyond compliance with recognized standards for electromagnetic compatibility and electrical safety.

Therefore, I cannot populate the requested table and answer many of the questions based solely on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed technical performance study report.

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

1. A table of acceptance criteria and the reported device performance:

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 "Testing... demonstrated compliance" but does not detail the nature of this testing (e.g., number of units tested, types of image data used). This is a monitor, so "data provenance" in the sense of patient data is not applicable. The "testing" refers to product safety and performance testing.

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. This device is a display monitor. "Ground truth" in the context of diagnostic interpretation by experts is not relevant to its performance testing for regulatory submission. Its performance is measured against technical specifications and safety standards, not against human judgment for diagnostic accuracy.

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

• Not applicable. See answer to 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 a passive display monitor, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

• Not applicable. This is a display monitor, not an algorithm.

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

• Not applicable. For a display monitor, the "ground truth" would be the technical specifications (e.g., color accuracy measured by spectroradiometer, resolution by pixel count verification) and compliance with safety standards, not medical ground truth established by experts or pathology.

8. The sample size for the training set:

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

• Not applicable. See answer to point 8.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence for a medical monitor by comparing its intended use, technological characteristics, and compliance with general safety and EMC standards to a predicate device. It does not provide the kind of detailed performance study data, acceptance criteria, or ground truth establishment protocols that would be found in submissions for AI/ML-driven diagnostic devices.

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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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