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The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.

The Pensil Trauma is a wall-mounted radiographic cassette holder device.

I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for the "Pensil Trauma, Model WW56100" device, identifying it as a wall-mounted radiographic cassette holder.

While it mentions the device is "substantially equivalent" to legally marketed predicate devices, it does not include any specific performance metrics, acceptance criteria, or details regarding studies (sample sizes, ground truth, expert qualifications, etc.) that would prove the device meets such criteria.

The letter focuses on regulatory approval based on substantial equivalence, general controls, and compliance with manufacturing practices, rather than providing a technical performance evaluation.

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The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

The XRT 600 R/F and his component part is a device to visualize anatomical rne ANT 600 701 and nie compon of x-radiation into a vişual image through electronic amplification and to position a radiographic film cassette to obtain radiographs during fluoroscopy.

The provided text is a 510(k) K992603 clearance letter for the Wuestec XRT 600 R/F device, along with its "Indications For Use" statement.

This documentation does not contain any information regarding acceptance criteria, device performance metrics, or study design details. It is a regulatory approval document that states the device has been found substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

To answer your request, I would need a document such as:

• A premarket submission summary.
• A clinical study report.
• A scientific publication detailing the device's performance evaluation.

The current document only confirms the FDA's regulatory clearance for the device, not the technical or clinical performance data.

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The 4R and 5 mobile x-ray unit with image intensifier system has been designed for diagnosis, suitable for x-ray and radioscopy, and radiography dedicated to:

• Traumatology .
• Paediatrics
• Interventional radiology
• Peace maker implantation
• Operating theater
• Intensive care .
• Respiratory system ●
• Skeleton .

This device does not foresee any interaction with medicine, while the possibility of an interface with some devices like VCR or THERMAL PRINTER is foreseen.

C-Quest 4R and 5 mobile x-ray unit with image intensifier system

The provided document is a 510(k) premarket notification letter from the FDA for a device called "C-Quest 4R and C-Quest 5." This document grants market clearance based on substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating the device meets acceptance criteria.

The 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, focusing on indications for use and safety/effectiveness concerns addressed through general controls and potentially special controls for Class II devices. It does not typically require the submission of detailed performance studies against specific acceptance criteria in the same way a PMA (Premarket Approval) might.

Therefore, I cannot extract the requested information from the provided text. The document is essentially an FDA clearance letter, not a study report.

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The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.

The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands.

This FDA 510(k) clearance letter (K981880) for the DX-480 Add-on Digital Imager determines substantial equivalence to a predicate device. However, the provided document does not contain any information regarding acceptance criteria, device performance metrics, or details of a study used to validate the device's performance.

The letter primarily focuses on:

• Confirming the review of the 510(k) notification.
• Determining substantial equivalence to a legally marketed predicate device.
• Outlining regulatory classifications and general controls applicable to the device.
• Providing contact information for regulatory compliance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in the 510(k) summary or other supporting documentation submitted to the FDA, which is not included in the provided text.

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The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the LightLine-M device. The document is a clearance letter from the FDA for a 510(k) submission, confirming the device's substantial equivalence to previously marketed devices. It outlines regulatory requirements but does not include details about specific performance metrics or testing results.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device