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The Sony UP-DF500 FilmStation™ Digital Film Imager is a thermal printer intended for use in printing high-resolution diagnostic images from CT, MRI or other compatible medical imaging systems. The Sony UP-DF500 is intended for use by medical radiologists or other appropriately trained medical personnel.

The Sony UP-DF500 FilmStation™ Digital Film Imager is a general purpose thermal printer and is intended for use as an accessory to a wide variety of medical imaging systems for digitally printing black and white still images with DICOM format. The Sony UP-DF500 is connected to a DICOM network and the image from a compatible medical imaging system is transmitted via the DICOM network.

This document is a 510(k) Summary for the Sony UP-DF500 FilmStation™ Digital Film Imager, a thermal printer used for medical imaging. The 510(k) submission seeks to demonstrate substantial equivalence to existing predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific acceptance criteria in terms of quantitative performance metrics (e.g., resolution, spatial accuracy, density range, diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on overall purpose, function, and intended use.

The "reported device performance" is implicitly demonstrated through the claim of substantial equivalence and the device's technological characteristics aligning with the predicate devices. The core "performance" being evaluated is its ability to produce high-resolution diagnostic images comparable to other legally marketed thermal printers.

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

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically associated with clinical performance studies, which are not detailed in this 510(k) summary for a hardcopy device. The focus here is on engineering and functional equivalence rather than diagnostic accuracy on patient data.

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

Since no specific test set or clinical performance study is described, there's no mention of experts or their qualifications used to establish ground truth for a test set.

4. Adjudication Method:

Given the lack of a detailed clinical performance study with a test set, there is no adjudication method mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

The device is a thermal printer, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not conducted and is irrelevant to this device.

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

The device is a standalone thermal printer. Its "performance" is in printing images, not in making diagnostic interpretations. So, in a sense, its operation is "standalone" in its function of printing. However, this is not a standalone diagnostic algorithm in the context of typical AI medical device evaluations. The performance being evaluated is the quality of the hardcopy output itself, independent of human interpretation until the image is presented to a human.

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

Given the nature of the device as a thermal printer, the "ground truth" would likely relate to the accuracy of image reproduction – e.g., how closely the printed image matches the digital image data in terms of resolution, gray scale, and spatial fidelity, rather than a clinical ground truth like pathology for diagnostic accuracy. The document does not specify how this ground truth (for image reproduction quality) was established or evaluated.

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. This type of information is pertinent to machine learning algorithms, which are not applicable to a thermal printer in this context.

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

As there is no mention of a training set, there is no information on how its ground truth was established.

Summary of Acceptance Criteria and Study (Based on Inference from 510(k) Format):

Based on the nature of a 510(k) for a medical image hardcopy device, the "acceptance criteria" and "study" are not presented in the format often seen for diagnostic algorithms. Instead, acceptance is based on demonstrating substantial equivalence to already legally marketed predicate devices.

• Acceptance Criteria (Inferred):

  • Functionality: The device must perform the same overall function as predicate devices (printing high-resolution diagnostic images from CT, MRI, etc.).
  • Intended Use: The device must share the same intended use as predicate devices (for use by medical radiologists or other appropriately trained medical personnel for diagnostic purposes).
  • Technological Characteristics: The device must have technological characteristics (e.g., thermal printing technology, DICOM connectivity) that are sufficiently similar to predicate devices, or any differences do not raise new questions of safety or effectiveness.
  • Image Quality: Although not explicitly quantified, the implicit acceptance criterion is that the printed image quality (resolution, gray scale, lack of artifacts) must be diagnostically acceptable and comparable to the output of predicate devices.

• Study That Proves the Device Meets Acceptance Criteria (Inferred):
  The "study" is the 510(k) submission process itself, which involves:

  • Comparison to Predicate Devices: A detailed comparison of the Sony UP-DF500 FilmStation™ to the specified predicate devices (Agfa Drystar 4500, Codonics Horizon Series, Fuji Medical Dry Imager FM-DP 2636, Kodak Dry View 8610 Laser Imager) regarding their intended use, technological characteristics, and performance.
  • Engineering and Performance Testing (not detailed in this summary): While not explicitly described in the provided sections, a 510(k) submission would typically include engineering tests and performance data to demonstrate that the device meets its design specifications and produces images equivalent in quality to predicate devices. This would cover aspects like resolution, Dmax/Dmin, uniformity, and artifact levels, likely tested against industry standards or internal specifications, rather than a clinical study with patient cases. The FDA's review and ultimate clearance (FEB 0 4 2003) signify that these factors were deemed acceptable.

In essence, for this type of device, the "study" is a technical comparison and evaluation of the device's technical specifications and output quality to ensure it is as safe and effective as existing legally marketed devices, rather than a clinical trial assessing diagnostic accuracy with expert readers.

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The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony. PCM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.

The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is a general purpose computer monitor which has been modified for use in medical settings for patient monitoring applications. It will display images received from a computer system and is designed for use with PC-compatible computers.

The provided 510(k) summary for the Sony PGM-100P1MD Trinitron® Color Graphic Monitor does not describe acceptance criteria or a study proving the device meets specific performance metrics.

This document is a premarket notification for a medical device (a color graphic monitor) intended for patient monitoring applications. The primary focus of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already legally marketed in the US, rather than proving performance against specific acceptance criteria through a dedicated study.

Here's why the requested information isn't present and what the document does provide:

• Substantial Equivalence: The document explicitly states the FDA's finding of "substantial equivalence" to predicate devices (Sony Trinitron Color Video Monitor PVM-1343MD, Electrohome M1544/1744 High Resolution Monochrome Monitors, and Siemens Sirecust 1481T Digital Telemetry System). This means the manufacturer argued that the new device has the same intended use and similar technological characteristics as existing, legally marketed devices, and does not raise new questions of safety or effectiveness.
• Device Description and Intended Use: These sections clarify what the device is and how it's meant to be used (displaying multi-paramater data in graphic format for patient monitoring).
• Technological Characteristics: This section highlights that the primary difference from predicate devices is "higher resolution." While improved resolution is a performance characteristic, the document doesn't quantify it with acceptance criteria or present data from a study specifically designed to prove this higher resolution meets a defined standard.

Therefore, for the specific questions asked, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable/Not provided. No test set or data provenance is mentioned in the context of performance testing. The comparison is based on technological characteristics and intended use relative to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No ground truth establishment is described.
4. Adjudication method for the test set: Not applicable/Not provided. No 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, this is not applicable. This device is a monitor, not an AI-assisted diagnostic tool. Such a study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a hardware monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. No performance testing against a ground truth is described.
8. The sample size for the training set: Not applicable/Not provided. This is a hardware device; there is no mention of a "training set" in the context of machine learning or algorithms.
9. How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided 510(k) summary is a regulatory filing demonstrating substantial equivalence, not a detailed scientific study on device performance against specific acceptance criteria.

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The Sony DKR-700 Digital Still Recorder is intended for use in the recording of video images obtained from medical imaging systems for purposes such as administration, patient record archival storage and education. For example, the DKR-700 Digital Still Recorder can be utilized for recording images acquired by video cameras, fluoroscopic X-ray systems, angiographic X-ray systems, optical microscopes or other systems which produce a compatible video signal.

The Sony DKR-700 Digital Still Recorder is a general purpose electronic device for digitally recording both color and black and white still images from a variety of analog sources in either a noncompressed or compressed mode to a Sony Magneto Optical (MO) MiniDisc. Recorded images may then be played back from the MO disc and viewed on a standard (analog) video monitor, or may be transmitted via a SCSI interface for importing into a PC/Windows application environment. With the DKR-700, information such as date, image number and image name can be attached to each image. Specific images can then be searched for and retrieved at the user's request.

The major components of the Sony DKR-700 Digital Still Recorder are the recorder, the recording media and the DKR-700 plug-in software. The RM-C700 Remote Control Unit and foot switches are optional accessories for external control of the device.

The provided text describes a medical device, the Sony DKR-700 Digital Still Recorder, and its intended use, but it does not contain information about acceptance criteria, a study proving device performance, or any of the detailed metrics requested in your prompt.

The document is a 510(k) summary, which is a premarket notification submitted to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. This type of submission typically focuses on technological characteristics and equivalence to predicate devices rather than detailed performance studies with acceptance criteria, ground truth, or expert review panels.

Therefore, I cannot populate the table or answer the specific questions about performance studies, sample sizes, experts, or ground truth with the information provided. The document outlines:

• Device Name: Sony DKR-700 Digital Still Recorder
• Intended Use: Recording video images from medical imaging systems for administration, patient record archival, and education. It's an accessory to various medical imaging devices.
• Predicate Devices: Sony DVR-10 Digital Videocassette Recorder and Sony Laser VideoDisc Recording (LVR) System.
• Technological Characteristics: Records digital still images from analog sources to a Sony Magneto Optical (MO) MiniDisc, with playback and SCSI interface for PC integration. The primary difference from predicates is the recording media.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a performance testing protocol, which are not present in this 510(k) summary.

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