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R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.

These are square-field single- or, optionally, multi-layer x-ray collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.

The provided K110856 document details the premarket notification for RALCO's R104/A, R108, and R108 F Manual X-Ray Collimators. However, it does not contain specific acceptance criteria or an explicit study report with performance metrics in the way a clinical trial or algorithm validation study would.

Instead, this submission focuses on establishing substantial equivalence to a predicate device (K030487 Ralco R72 Manual Collimator) based on bench testing and safety testing. The core argument is that the new devices are "as safe and effective" as the predicate device due to similar design, intended use, and conformance to US Performance Standards.

Here's an analysis based on the information provided, highlighting what is and is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative metrics for "safety" and "effectiveness" are not provided. For example, there are no reported measurements of radiation leakage, field size accuracy (beyond the 2% tolerance claim), or shutter precision from the bench tests.
• The document does not elaborate on the specific "bench, safety test, and laboratory testing" that led to these conclusions.

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

• Sample Size: Not specified. The document refers to "bench, safety test, and laboratory testing" but does not provide details on the number of units tested or the specific conditions.
• Data Provenance: Not specified, but generally, bench and laboratory testing for a device like this would be conducted by the manufacturer (Ralco srl, in Italy). The testing would be prospective in nature, as it's part of the design verification and validation process for the new device.

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

• This type of information is not applicable to this submission. The device is a mechanical X-ray collimator. Its performance is evaluated through engineering and physical measurements (e.g., light field accuracy, shutter movement, structural integrity, electrical safety), not through expert interpretation of medical images or clinical outcomes. Therefore, there is no "ground truth" derived from medical experts in the context of a diagnostic reading study.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, typically for AI algorithms or reader performance studies. This is a physical device.

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

• Not applicable. This submission is for a physical medical device (X-ray collimator), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.

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

• Not applicable. This is a hardware device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance would be objective physical measurements and engineering specifications, e.g., using calibrated measuring equipment to verify dimensions, light intensity, field accuracy, mechanical movement tolerances, and electrical safety parameters. It is not based on expert consensus, pathology, or outcomes data in the medical sense.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" for its development or validation.

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

• Not applicable. See point 8.

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This device is intended to be used in radiology.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.

This device is for diagnostic use.

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view.

The provided document is an FDA 510(k) clearance letter for the R-201 device, which is a diagnostic x-ray beam-limiting device (collimator).

Unfortunately, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.

The letter primarily provides:

• Confirmation of substantial equivalence to predicate devices.
• The device's regulation number, name, and product code.
• Indications for use.
• General regulatory information and requirements for marketing the device.

It does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth establishment for any studies.
3. Information on expert qualifications, adjudication methods, or MRMC studies.
4. Data on standalone algorithm performance.
5. Training set details.

To answer these questions, one would need to review the original 510(k) submission (K101036) document, which would contain the performance data and testing methodology used to demonstrate substantial equivalence. The provided FDA letter is merely the agency's response to that submission.

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This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
This device is intended to be used in the radiology.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the R-20J is the same as that of predicate beam limiting device R-30H (K031771). Consequently, the indications for use of the R-20J are also the same as that of the beam limiting device R-30H (K031771) and there are no additional indications.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a Beam Limiting Device R-20J. It does not contain information about acceptance criteria or a study proving that the device meets such criteria because it pertains to a traditional medical device (a collimator), not an AI/ML-driven device.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "device performance," "sample size," "ground truth," "MRMC study," or "standalone performance" as they relate to AI/ML device testing are not applicable to this document.

Ask a specific question about this device

This collimator is to be used in conjunction with an x-ray generator and x-ray tube to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Beam Limiting Device R-30H). This document does not contain information about acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment for a device's performance.

The letter's purpose is to state that the FDA has reviewed the manufacturer's premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than detailed performance study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

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General Purpose Fluoroscope Applications

Not Found

The provided text describes a 510(k) clearance letter from the FDA for a device called "Facts Monoblock Diagnostic X-Ray Tube Housing Assembly." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria, device performance, study details (sample sizes, ground truth, expert qualifications, etc.), or specific comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the given text. The document is solely a regulatory clearance letter acknowledging substantial equivalence based on prior submissions, not a scientific study report.

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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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The AXT 150M and/or its variations is intended to be used by or under the authority of a licensed MD or RT. The AXT 150M and/or its variations is accessories to control the x-ray beam for use on a diagnostic Imaging equipment. The intended market will consist of Original Equipment Manufacturers (OEM), as designed to be adapted to various x-ray systems.

AXT 150M Manual Collimator

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (AXT 150M Manual Collimator), indicating that the device is substantially equivalent to a predicate device.

The letter and the "Indications For Use" statement do not include:

• A table of acceptance criteria and reported device performance.
• Details about a study or clinical trial.
• Sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details.

Therefore, I cannot fulfill the request based on the provided input.

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