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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

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The UDI 2W system is a direct digital radiographic upgrade unit used to directly capture and convert conventinal projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, it can be printed and/or stored electronically. The Meridian UDI 2W unit provides digital radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The UDI 2W system can be used with a fixed, portable, or wireless 17"X17" or 14"x17" sensor plate. The UDI 2W can not be used for Mammography applications.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Universal Digital Interface 2W (UDI2W) and primarily discusses its regulatory classification, indications for use, and compliance requirements. It does not include details on specific performance metrics, study designs, sample sizes, or expert qualifications.

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The UDI 2 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.

Universal Digital Interface 2 (UDI 2)

This document is a 510(k) clearance letter for the Universal Digital Interface 2 (UDI 2) and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The letter primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, many of the requested details are not present in the provided text.

Based on the provided text, here's what can be extracted:

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

This information is not present in the document. The FDA letter is a regulatory clearance based on substantial equivalence, not a performance report.

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

This information is not present in the document. The letter does not detail the testing methodology or data sets used for demonstrating substantial equivalence.

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):

This information is not present in the document.

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

This information is not present in the document.

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:

This information is not present in the document. The UDI 2 is described as a "Direct Digital Radiography Upgrade unit" that converts X-ray images to digital; there is no indication that it includes AI or that an MRMC study related to AI assistance was performed.

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

This information is not present in the document. The device description does not suggest an "algorithm-only" performance evaluation as it is an imaging system.

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

This information is not present in the document.

8. The sample size for the training set:

This information is not present in the document.

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

This information is not present in the document.

Summary of what the document does provide:

• Device Name: Universal Digital Interface 2 (UDI 2)
• 510(k) Number: K140251
• Primary Function: A Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images.
• Output: Diagnostic images viewable on a monitor, which can be manipulated, printed, and/or e-mailed.
• Application: Provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics, and imaging centers.
• Sensor Plate Size: 17" x 17" or 14" x 17".
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, Regulatory Class II.
• Type of Use: Prescription Use.

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the full 510(k) submission documentation, which is not included in this FDA clearance letter.

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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

This document is a 510(k) premarket notification decision letter from the FDA for the Universal Digital Interface (UDI) 1717. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more extensive submission summary.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document primarily focuses on the FDA's decision regarding substantial equivalence based on the device's indications for use.

To obtain the requested information, you would need to consult the actual 510(k) submission document (K112527) which would contain the technical specifications, testing protocols, and performance data used to demonstrate substantial equivalence to a predicate device.

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The UDI 1417W System is a Direct Digital Radiography Upgrade unit used to directly capture and conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The portable, Wireless 14" x 17" sensor plate captures large patient imaging and areas. The UDI 1417W cannot be used for Mammography applications.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Universal Digital Interface-Wireless (UDI 1417 W)". This document is a clearance letter, not a study report. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain the detailed information requested regarding:

• Acceptance criteria table and reported device performance
• Sample sizes used for test and training sets
• Data provenance
• Number of experts for ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training set was established

This type of information would typically be found in a separate Premarket Notification 510(k) Summary or the Design Validation Report submitted as part of the 510(k) application, not in the FDA's clearance letter itself.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA compared the UDI 1417W to existing, legally marketed devices and found them to be similar enough in terms of safety and effectiveness, based on the data submitted by Meridian Medical Systems. The letter itself does not describe the specific studies and their results that led to this determination.

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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas. The UDI 1717 cannot be used for Mammography applications.

Universal Digital Interface (UDI) 1717

This looks like an FDA 510(k) clearance letter and an "Indication for Use" statement, not a scientific study or clinical trial report. As such, it does not contain the detailed information required to answer your questions about acceptance criteria and study results.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a regulatory approval letter. It confirms that the device (Universal Digital Interface (UDI) 1717) is substantially equivalent to a legally marketed predicate device. It does not specify any acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present any device performance data from a specific study.
• No Study Details: This document does not describe any specific study conducted to prove the device meets acceptance criteria. It doesn't mention sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, standalone performance, or training set details.

To answer your questions, you would need access to the actual 510(k) summary or the original submission documents, which contain the technical details and performance data that the FDA reviewed.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.

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