(125 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viral Penetration | "allows no penetration of virus and provides effective protection against viral penetration." |
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.
§ 892.1620 Cine or spot fluorographic x-ray camera.
(a)
Identification. A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.(b)
Classification. Class II.