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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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Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.

The provided text describes a submission for a 510(k) premarket notification for the RALCO Model R225 ACS Automatic X-RAY Collimator. This device is a collimator, which is a component of an X-ray system, and therefore, the assessment criteria and study design are different from those for AI-powered diagnostic devices.

The submission focuses on establishing substantial equivalence to a predicate device (K072780, Ralco Model R302DACS Automatic Collimator) rather than demonstrating a specific performance metric against a "ground truth" in the way an AI diagnostic algorithm would.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable in the context of this submission. The submission relies on "bench, safety test, and laboratory testing" rather than a clinical dataset with a specific "test set" for performance evaluation against a diagnostic ground truth.
• Data Provenance: Not explicitly stated as clinical data from specific countries or retrospective/prospective studies. The testing is described as "bench, safety test, and laboratory testing," which typically refers to engineering and quality assurance activities conducted by the manufacturer (RALCO srl in Biassono, Italy).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study requiring expert consensus for a diagnostic "ground truth." The evaluation focuses on the engineering performance and safety of the collimator itself, which are assessed through engineering tests and adherence to standards.

4. Adjudication method for the test set:

• Not applicable. There is no specific "test set" requiring adjudication in the context of this submission.

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:

• No MRMC comparative effectiveness study was done. This device is a hardware component (an X-ray collimator), not an AI algorithm intended to assist human readers.

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:

• Not applicable in the sense of clinical diagnostic ground truth (e.g., pathology, patient outcomes). The "ground truth" here is adherence to engineering specifications, safety standards (e.g., CSA Listed to US Standards), and functional equivalence to the predicate device as demonstrated through "bench, safety test, and laboratory testing."

8. The sample size for the training set:

• Not applicable. This is a manufactured hardware device, not a machine learning model that requires a training set.

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

• Not applicable. As noted above, this device does not involve a training set or associated ground truth in the context of machine learning.

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Model R605DASM Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

This device is a compact radiological automatic collimating system for round and elliptic fields designed to operate with a mobile "C" arm Image Intensifier cquipment. The round and elliptical fields are defined as follows: The round field by 8 lead shutters located near the exit window and a brass cone near the x-ray focus; the elliptical field by the round field and two pairs of lead rectangular shutters located near the collimator entrane window. Round and elliptical field shutters are controlled by 5 stepping motors. The circlinator features a microprocessor circuit built into the collimator to control the 5 stepping-motornia external signal source with CanBus protocol. The circuits return a CanBus protocol signal to indicate correct motor positioning. The two pairs of lead rectangular shutters move isignify and both rotate ± 360° ..

This document is a 510(k) summary for the Ralco Model R605DASM Automatic X-RAY Collimator. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

Here's the breakdown regarding acceptance criteria and the study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., accuracy, precision, error rates) for the device. Instead, the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, and substantial equivalence to a legally marketed predicate device.

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

The document mentions "bench, safety test, and laboratory testing" but does not provide details on the sample size used for any test sets or the data provenance (e.g., country of origin, retrospective/prospective nature). It focuses on the physical characteristics and control mechanisms of the collimator.

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

This information is not applicable and not provided. The device described is an automatic X-ray collimator, a hardware component that limits the X-ray beam. Its performance is assessed through engineering and safety tests, not through clinical interpretation requiring expert consensus on ground truth (like in image analysis AI).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As mentioned above, the assessment is based on physical and functional testing, not on clinical adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for devices that provide diagnostic interpretations or assist human readers in making decisions (e.g., AI for image analysis). The Ralco Model R605DASM is a hardware device for controlling X-ray beams.

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

This is not directly applicable in the typical sense of an "algorithm only" standalone performance study for an AI device. The device itself is an automatic collimator, meaning it operates autonomously to control the X-ray beam based on its internal programming and external signals. The "tests" performed would assess its standalone mechanical and electronic performance, in that sense, it is "standalone." However, this is not a standalone AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established engineering specifications, safety standards, and the physical accuracy of the collimator's movements and beam-limiting capabilities. For example:

• Engineering Specifications: Whether the 5 stepping motors accurately position the shutters.
• Safety Standards: Adherence to US Performance Standards and CSA Listing for safety.
• Functional Testing: The ability to correctly define round and elliptical fields as intended.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a mechanical and electronic system, not an AI model that requires a "training set" in the context of machine learning.

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

This information is not applicable and not provided. As explained in point 8, there is no "training set" in the typical sense for this device.

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Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.

The provided text is a 510(k) summary for the RALCO srl Model R302DACS/A Automatic X-RAY Collimator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the comprehensive completion of the requested table and study information.

The document primarily focuses on establishing substantial equivalence based on safety and effectiveness compared to predicate devices, rather than presenting a performance study with defined acceptance criteria and quantitative results for the new device.

Therefore, I cannot populate the table or provide the requested study details as the information is not present in the provided text.

Here is an explanation of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: The document states, "The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device." It also mentions "analyzing both bench and safety testing data." However, it does not define what these "results" or "data" actually are, what specific performance metrics were measured (e.g., accuracy of collimation, field size precision), nor what the predefined "acceptance criteria" for these metrics were.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Training Set Details: None of this information is available in the provided text. The submission focuses on regulatory compliance and comparison to predicate devices, not on a detailed clinical or technical performance study with these elements.
• Type of Ground Truth: While it mentions "bench, safety test laboratory and user testing," it doesn't specify if this involved expert consensus, pathology, or other forms of "ground truth" as typically understood in a performance study for AI/diagnostic devices. For an X-ray collimator, ground truth would likely relate to the actual dimensions and alignment of the X-ray field versus the device's output, but this is not detailed.

In summary, the provided 510(k) pertains to a hardware device (X-ray collimator) and emphasizes regulatory equivalence based on general safety and effectiveness. It does not include the type of detailed performance study data, acceptance criteria, or ground truth establishment typically found for AI/software-based diagnostic devices.

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Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.

R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.

Here's a breakdown of the acceptance criteria and study information for the Ralco Model R72 X-Ray Collimator, based on the provided 510(k) summary:

This device (Ralco Model R72 X-Ray Collimator) is not an AI-powered device, therefore, many of the requested sections (sample sizes for test/training sets, expert details, MRMC studies, standalone performance) are not applicable as they relate to studies typically performed for AI/ML medical devices. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and user testing.

Acceptance Criteria and Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is a comparison to a legally marketed predicate device (Ralco Model R302, K946320) to demonstrate substantial equivalence. The device is an X-Ray Collimator, a hardware component, not an AI/ML device.

1. Sample size used for the test set and the data provenance:

   • Test Set: Not explicitly quantifiable in terms of "samples" or "data" as would be for an AI model. The testing involved "bench and user testing." The document does not provide the number of units tested or the specific conditions of "user testing."
   • Data Provenance: Not specified, but implied to be from testing conducted by Ralco srl (Italy). The nature of "bench and user testing" suggests prospective testing rather than retrospective data analysis.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is a hardware device submission, not an AI/ML device requiring expert ground truth for classification or interpretation. Testing would involve adherence to technical specifications and safety standards.

3. Adjudication method for the test set:

   • Not applicable for this type of submission. The evaluation is based on technical specifications and functional equivalence.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in image interpretation.

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

   • Not applicable. This device is a passive hardware component, not an algorithm. Its function is to limit the X-ray beam, and its performance is inherent in its design and physical characteristics, not in an interpretive algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance would be derived from engineering specifications, direct measurements (bench testing), and compliance with recognized standards (e.g., 21 CFR 1020.30, UL 2601, IEC 60601-1). For functional aspects like timer accuracy or beam coverage, the ground truth would be the expected performance based on design and physical measurement.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable, as there is no training set.

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