Search Results

This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.

This Device is a Charged Coupled Device (CCD) camera for use in digital radiography, including DSA, high-resolution cardiology, and low dose fluoroscopy. It is designed for use with X-Ray image intensifiers in diagnostic imaging chains. The purpose of this device is to convert the visible image at the output of the X-Ray system image intensifier, to a video signal for display on a TV monitor.

The provided text is a 510(k) premarket notification approval letter for the "Model PKP-06000 CCD Camera." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and contact information for further inquiries.

Therefore, I cannot provide a response to your request based on the given input text. The information required (acceptance criteria, study details, human-in-the-loop performance, etc.) is typically found in the 510(k) summary or detailed device description, which is not present here.

Ask a specific question about this device

The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machine utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. The DXC provides a sterile barrier between the patient and the X-ray machine. Contaminants from the operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation. This product is marketed towards surgeons and hospitals concerned with the convenience and protection of covering an operative X-ray machine, so that it will not contaminate the sterile field.

The Disposable X-Ray Cover is a sterile cover or drape for operative X-ray machines utilised during surgical procedures which require a sterile environment. It allows a surgeon to adjust and manoeuvre at will, without compromising the sterile field. As with most major surgical equipment, X-ray machines cannot be sterilised. It would damage them, rendering them useless. The Disposable X-Ray Cover provides a sterile barrier between the patient and the X-ray machine. Contaminants from operative equipment (the X-ray machine) cannot penetrate through to infect the patient. Patient contaminants (such as blood and bodily fluids) cannot penetrate through to damage the machine. The DXC is disposable and single patient use only, so there is no cross contamination between patients. It is sterilised via gamma radiation.

The provided document is a 510(k) summary for the Disposable Universal X-Ray Cover (DXC 8015) and Disposable Mini X-Ray Cover (DXC 8025) by Fairmont Medical Products, Pty., Ltd. It details the device's purpose and sterilization method but does not contain a comprehensive study description with detailed acceptance criteria and reported device performance in the format requested.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Clinical testing for viral penetration has demonstrated..." but does not specify the sample size for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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

An MRMC study is not mentioned in the document. The device is a physical sterile cover, not an AI software, so an MRMC study with human readers assisting AI would not be applicable.

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

This is not applicable as the device is a physical sterile cover, not an algorithm or AI system.

7. Type of Ground Truth Used:

The document states "Clinical testing for viral penetration has demonstrated...". This implies laboratory-based microbiological testing or a similar scientific method to assess viral blockage, rather than expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. Sample Size for the Training Set:

This is not applicable as the device is a physical cover and does not involve AI or machine learning algorithms that require a training set.

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

This is not applicable for the same reasons as above.

Summary of Missing Information:

The 510(k) summary provides a high-level overview of the device and its intended use, focusing on its sterile barrier function and viral penetration. However, it lacks the detailed methodology and results of the clinical testing that would be expected to fully address the requested information, particularly regarding the specifics of the viral penetration tests (sample size, exact criteria, and detailed results). This is typical for 510(k) summaries for Class II devices that are often cleared based on substantial equivalence to predicate devices, where detailed study designs might be in the full submission but not in the publicly available summary.

Ask a specific question about this device